Trial Outcomes & Findings for Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease (NCT NCT04299308)
NCT ID: NCT04299308
Last Updated: 2025-07-23
Results Overview
FDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) calculated from native-space region of interest (ROI).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
Resting Vs acute exercise bout: ~1 month
Results posted on
2025-07-23
Participant Flow
Participant milestones
| Measure |
Moderate Intensity Aerobic Exercise
45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
High Intensity Aerobic Exercise
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
27
|
31
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Moderate Intensity Aerobic Exercise
45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
High Intensity Aerobic Exercise
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
issue with PET image (1)
|
1
|
0
|
Baseline Characteristics
Acute Exercise and the Cerebral Metabolic Response in Aging and Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
Moderate Intensity Aerobic Exercise
n=29 Participants
45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
High Intensity Aerobic Exercise
n=31 Participants
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=99 Participants
|
27 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Age, Continuous
|
72.2 years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
74.2 years
STANDARD_DEVIATION 8.1 • n=107 Participants
|
73.2 years
STANDARD_DEVIATION 7.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
31 participants
n=107 Participants
|
60 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Resting Vs acute exercise bout: ~1 monthFDG PET measures reflecting cerebral metabolism standardized to the uptake value of the cerebellum and standardized uptake value ratios (SUVR) calculated from native-space region of interest (ROI).
Outcome measures
| Measure |
Moderate Intensity Aerobic Exercise
n=27 Participants
45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
High Intensity Aerobic Exercise
n=31 Participants
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
|---|---|---|
|
Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) Metabolism (Standard Uptake Value Ratio)
|
-0.0514 SUVR
Standard Deviation 0.03
|
-0.0667 SUVR
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: Resting Vs acute exercise bout: ~1 monthPopulation: Individuals who completed both visits with blood draws available
Change in lactate AUC between the resting and exercise condition
Outcome measures
| Measure |
Moderate Intensity Aerobic Exercise
n=28 Participants
45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
High Intensity Aerobic Exercise
n=31 Participants
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
|---|---|---|
|
Lactate Area Under the Curve
|
40.3 AUC change (mmol/L*min)
Standard Deviation 27.5
|
97.0 AUC change (mmol/L*min)
Standard Deviation 50.8
|
SECONDARY outcome
Timeframe: Resting Vs acute exercise bout: ~1 monthPre/post change in circulating Brain Derived Neurotrophic Factor between the resting and exercise conditions
Outcome measures
| Measure |
Moderate Intensity Aerobic Exercise
n=28 Participants
45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
High Intensity Aerobic Exercise
n=31 Participants
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
|---|---|---|
|
Brain-derived Neurotrophic Factor (BDNF) Change
|
610.2 pg/mL
Standard Deviation 1071.9
|
353.3 pg/mL
Standard Deviation 239.8
|
Adverse Events
Moderate Intensity Aerobic Exercise
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Intensity Aerobic Exercise
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Moderate Intensity Aerobic Exercise
n=29 participants at risk
45-55% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.45 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.55 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
High Intensity Aerobic Exercise
n=31 participants at risk
65-75% of heart rat reserve (HHR) Low range = ((Max HR from Visit 1) - Resting HR ) \* 0.65 + Resting HR High range = ((Max HR from Visit 1) - Resting HR) \* 0.75 + Resting HR
Aerobic Exercise: Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
|
|---|---|---|
|
Cardiac disorders
Abnormal ECG
|
0.00%
0/29 • 1 month
|
3.2%
1/31 • Number of events 1 • 1 month
|
|
Gastrointestinal disorders
Nausea
|
3.4%
1/29 • Number of events 1 • 1 month
|
3.2%
1/31 • Number of events 1 • 1 month
|
|
Infections and infestations
Covid diagnosis
|
3.4%
1/29 • Number of events 1 • 1 month
|
0.00%
0/31 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place