Trial Outcomes & Findings for COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE) (NCT NCT04595773)

NCT ID: NCT04595773

Last Updated: 2026-05-12

Results Overview

The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

Before and after 10 weeks

Results posted on

2026-05-12

Participant Flow

48 participants who consented to the study * 40 participants were randomized to study interventions * 6 participants were screen failure * One participant withdrew before randomization * One participant withdrew after randomization and prior to start of intervention

Participant milestones

Participant milestones
Measure
Aerobic Exercise Intervention (AET+)
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks.
Control Group (CON)
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks.
Period 1 - Week 1-10
STARTED
20
20
Period 1 - Week 1-10
COMPLETED
20
20
Period 1 - Week 1-10
NOT COMPLETED
0
0
Period 2 - Week 11- 20
STARTED
0
20
Period 2 - Week 11- 20
COMPLETED
0
19
Period 2 - Week 11- 20
NOT COMPLETED
0
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Aerobic Exercise Intervention (AET+)
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks.
Control Group (CON)
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks.
Period 2 - Week 11- 20
Physician Decision
0
1

Baseline Characteristics

COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control Group (CON)
n=20 Participants
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks, then crossed over to perform aerobic exercise three times a week for 10 weeks.
Total
n=40 Participants
Total of all reporting groups
Aerobic Exercise Intervention (AET+)
n=20 Participants
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks.
Age, Categorical
<=18 years
0 Participants
n=504 Participants
0 Participants
n=2016 Participants
0 Participants
n=1512 Participants
Age, Categorical
Between 18 and 65 years
20 Participants
n=504 Participants
38 Participants
n=2016 Participants
18 Participants
n=1512 Participants
Age, Categorical
>=65 years
0 Participants
n=504 Participants
2 Participants
n=2016 Participants
2 Participants
n=1512 Participants
Sex: Female, Male
Female
16 Participants
n=504 Participants
31 Participants
n=2016 Participants
15 Participants
n=1512 Participants
Sex: Female, Male
Male
4 Participants
n=504 Participants
9 Participants
n=2016 Participants
5 Participants
n=1512 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=504 Participants
7 Participants
n=2016 Participants
4 Participants
n=1512 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
17 Participants
n=504 Participants
33 Participants
n=2016 Participants
16 Participants
n=1512 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=504 Participants
0 Participants
n=2016 Participants
0 Participants
n=1512 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=504 Participants
0 Participants
n=2016 Participants
0 Participants
n=1512 Participants
Race (NIH/OMB)
Asian
3 Participants
n=504 Participants
4 Participants
n=2016 Participants
1 Participants
n=1512 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=504 Participants
0 Participants
n=2016 Participants
0 Participants
n=1512 Participants
Race (NIH/OMB)
Black or African American
3 Participants
n=504 Participants
5 Participants
n=2016 Participants
2 Participants
n=1512 Participants
Race (NIH/OMB)
White
13 Participants
n=504 Participants
29 Participants
n=2016 Participants
16 Participants
n=1512 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=504 Participants
2 Participants
n=2016 Participants
1 Participants
n=1512 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=504 Participants
0 Participants
n=2016 Participants
0 Participants
n=1512 Participants

PRIMARY outcome

Timeframe: Before and after 10 weeks

Population: All participants who completed the first 10 weeks of the study intervention.

The 6-minute walk test (6MWT) is a measure of physical capacity and subjects are instructed to walk as far as possible around a pre-measured walking course over a time period of six minutes. The 6-minute walk test distance (6MWD) is the total distance walked in meters during the 6MWT and greater distance walked means better physical capacity. This outcome is reported as the difference between time-points (post- minus pre-10 weeks).

Outcome measures

Outcome measures
Measure
Aerobic Exercise Intervention (AET+)
n=20 Participants
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks.
Control Group (CON)
n=20 Participants
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks.
Change in 6-minute Walk Test Distance (6MWD)
57.7 Meters
Standard Deviation 44.67
18.4 Meters
Standard Deviation 25.67

Adverse Events

Aerobic Exercise Intervention (AET+)

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

Control Group (CON) - Education

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Control Group (CON) - Exercise

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Aerobic Exercise Intervention (AET+)
n=20 participants at risk
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week plus weekly education for 10 weeks.
Control Group (CON) - Education
n=20 participants at risk
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed weekly education for 10 weeks.
Control Group (CON) - Exercise
n=20 participants at risk
Participants post-acute infection from SARS-CoV-2 with persistent sequelae performed aerobic exercise three times a week for 10 weeks.
Ear and labyrinth disorders
Vertigo
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Gastrointestinal disorders
Diarrhoea
10.0%
2/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Investigations
Electrocardiogram abnormal
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Investigations
Imaging procedure
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Gastrointestinal disorders
Irritable bowel syndrome
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
General disorders and administration site conditions
Fatigue
10.0%
2/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
General disorders and administration site conditions
Influenza like illness
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
General disorders and administration site conditions
Non-cardiac chest pain
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Nervous system disorders
Headache
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Cardiac disorders
Atrial fibrillation
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
General disorders and administration site conditions
Pain
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Infections and infestations
Otitis media
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Infections and infestations
Otitis media acute
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Infections and infestations
Skin infection
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Infections and infestations
Urinary tract infection
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Injury, poisoning and procedural complications
Fall
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Injury, poisoning and procedural complications
Vaccination complication
20.0%
4/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
10.0%
2/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Investigations
Coronavirus test positive
15.0%
3/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
10.0%
2/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
15.0%
3/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Musculoskeletal and connective tissue disorders
Arthralgia
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Musculoskeletal and connective tissue disorders
Myalgia
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cyst
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Psychiatric disorders
Anxiety
10.0%
2/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Psychiatric disorders
Depression
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Cough
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Pharyngitis
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Pharyngitis streptococcal
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Rhinitis
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Sinusitis
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
15.0%
3/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
10.0%
2/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Skin and subcutaneous tissue disorders
Dermatitis allergic
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Skin and subcutaneous tissue disorders
Rash
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Skin and subcutaneous tissue disorders
Skin irritation
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
Vascular disorders
Hypotension
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
0.00%
0/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.
5.0%
1/20 • Start of study to end of on-site study completion, ~3 months for Aerobic Exercise Intervention (AET+) and ~6 months for Control Group (CON)
Adverse events (AEs) were defined as any symptom or condition occurring after study initiation that was not present at baseline. For conditions or symptoms present at baseline, events were reported as adverse events only if there was a worsening in severity or an increase in frequency during the study period.

Additional Information

Dr. Leighton Chan

National Institutes of Health Clinical Center (NIH CC)

Phone: 1 301 496 4300

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place