Trial Outcomes & Findings for Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training (NCT NCT03750006)

NCT ID: NCT03750006

Last Updated: 2024-08-30

Results Overview

6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

baseline and at participant completion, an average of 3 months

Results posted on

2024-08-30

Participant Flow

Recruitment from 12/3/2018 - 12/31/2019. Recruitment occurred at the VA Western New York including through posted advertisements and word of mouth.

11 individuals were excluded due to the COVID pandemic.

Participant milestones

Participant milestones
Measure
HIIT Intervention
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Overall Study
STARTED
42
Overall Study
COMPLETED
23
Overall Study
NOT COMPLETED
19

Reasons for withdrawal

Reasons for withdrawal
Measure
HIIT Intervention
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Overall Study
Withdrawal by Subject
8
Overall Study
COVID PANDEMIC
11

Baseline Characteristics

Enhancing Functional Capacity in Older Adults With Short Session High Intensity Interval Training

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Age, Continuous
71.9 years
STANDARD_DEVIATION 6.8 • n=99 Participants
Sex: Female, Male
Female
1 Participants
n=99 Participants
Sex: Female, Male
Male
22 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
23 Participants
n=99 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=99 Participants
Race (NIH/OMB)
Asian
0 Participants
n=99 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=99 Participants
Race (NIH/OMB)
Black or African American
4 Participants
n=99 Participants
Race (NIH/OMB)
White
19 Participants
n=99 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=99 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
Region of Enrollment
United States
23 Participants
n=99 Participants
BMI
30.6 kg/m^2
STANDARD_DEVIATION 0.6076 • n=99 Participants
Smoking status
Non-smoker
5 Participants
n=99 Participants
Smoking status
Former Smoker
16 Participants
n=99 Participants
Smoking status
Current Smoker
2 Participants
n=99 Participants

PRIMARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
6-minute Walk at Baseline and Endpoint
Baseline
418.2 meters
Standard Deviation 72.2
6-minute Walk at Baseline and Endpoint
Endpoint
436.8 meters
Standard Deviation 55.6

PRIMARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Population: One participant was not able to complete the assessment due to scheduling conflict.

Physical Activity Enjoyment Scale (PACES) that provides a valid instrument for assessing enjoyment in physical activity. There are 18 questions, each of which can receive a score from 1 to 7, where 7 is represents greater enjoyment. Scores presented as the mean across all questions giving an overall range of 1-7.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=22 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Physical Activity Enjoyment at Baseline and Endpoint
Baseline
6.1 Scores on a scale
Standard Deviation 0.8
Physical Activity Enjoyment at Baseline and Endpoint
Endpoint
6.2 Scores on a scale
Standard Deviation 0.8

PRIMARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Population: 8 participants were not able to complete the VO2max end point assessment due to COVID pandemic study cessation. One participant was not able to complete the assessment due to scheduling conflict.

Performed as part of a symptom limited maximal endurance test on a cycle ergometer

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=14 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
VO2max at Baseline and Endpoint
Baseline
18.67 mL/min/kg
Standard Deviation 5.12
VO2max at Baseline and Endpoint
Endpoint
19.93 mL/min/kg
Standard Deviation 5.59

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Short Physical Performance Battery (SPPB) is an objective assessment tool for evaluating lower extremity functioning in older persons, including balance, side-by-side/semi-tandem/tandem stands, and gait speed. There are 3 subscales, each of which can receive from 0 to 4 points. Therefore the total range of the test spans summed scores from 0 to 12, where 12 is the best outcome.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Short Physical Performance Battery at Baseline and Endpoint
Baseline
10.11 score on a scale
Standard Deviation 2.0
Short Physical Performance Battery at Baseline and Endpoint
Endpoint
10.46 score on a scale
Standard Deviation 2.1

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Fried frailty phenotype assessment includes: gait speed, grip strength, endurance, activity level, weight loss. These assessments report summed scores of 0 to 5, where 0 is the best outcome. If gait speed or grip strength (m/sec or kg) falls within the lowest quintile (20%) for the age and gender adjusted range, then it is given a score of "1". If both questions on the endurance or activity measures are positive then then it is given a score of "1". If weight loss is greater than 5% over the past year, then it is given a score of "1".

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Frailty at Baseline and Endpoint
Baseline
0.87 score on a scale
Standard Deviation 0.8
Frailty at Baseline and Endpoint
Endpoint
0.61 score on a scale
Standard Deviation 0.8

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). There are 14 subscales with scores of 1 to 5, where 5 is the better outcome. Therefore the total range of the test spans scores from 14 to 70, where 70 is the best outcome. The final score as a percentage with range being 0-100% and top being 100%. This percentage is calculated as: 100 \* ((participant's score - 14) / 56).

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Quality of Life Survey at Baseline and Endpoint
Baseline
80.0 % of Max Score
Standard Deviation 11.4
Quality of Life Survey at Baseline and Endpoint
Endpoint
85.6 % of Max Score
Standard Deviation 9.6

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Population: One participant was not able to complete the assessment due to scheduling conflict.

VA-SLUMS: VA Saint Louis University Mental Status screen. Survey includes 11 questions allowing a range of scores from 1-30 points, where higher scores represent greater mental outcomes.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=22 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Cognitive Survey at Baseline and Endpoint
Baseline
26.6 score on a scale
Standard Deviation 2.5
Cognitive Survey at Baseline and Endpoint
Endpoint
27.3 score on a scale
Standard Deviation 2.3

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

The Activities of Daily living and instrumental activities of daily living are a survey comprised of 14 questions including ability to: dress, eat, ambulate, toilet, hygiene, shop, housework, accounting, food preparation, and use transportation/telephone. Each question gives up to 1 point with a total range of 0-14. Higher scores indicate less independence and greater reliance on support.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint
Baseline
0.04 Score on a scale
Standard Deviation 0.21
Activities of Daily Living & Instrumental Activities of Daily Living Survey at Baseline and Endpoint
Endpoint
0.0 Score on a scale
Standard Deviation 0.0

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Population: RNA was isolated from participant serum samples and sequenced. However, none of the sequenced RNA were microRNA sequences, therefore analysis could not be performed. Consequently, there was no microRNA data that could be presented in a table.

Next Generation Sequencing of microRNA species from serum.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline

Population: No Statistical Analysis was performed as this was only a baseline measurement.

serum 25-hydroxy-vitamin D was measured from serum isolated from blood collected at baseline and measured using ELISA

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Serum 25-hydroxy-vitamin D at Baseline
26.9 ng/ml
Standard Deviation 15.2

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

C-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
C-reactive Protein Level at Baseline and Endpoint
Baseline
3.0 ug/uL
Standard Deviation 3.5
C-reactive Protein Level at Baseline and Endpoint
Endpoint
3.7 ug/uL
Standard Deviation 3.7

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Population: One participant was not able to complete the assessment due to scheduling conflict.

Maximal quadriceps strength. This will be measured with the MicroFET2 dynamometer with a readout in kilograms (kg) of force.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=22 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Quadriceps Strength at Baseline and Endpoint
Right Leg - Baseline
27.7 kg
Standard Deviation 6.8
Quadriceps Strength at Baseline and Endpoint
Right leg - Endpoint
31.1 kg
Standard Deviation 7.1
Quadriceps Strength at Baseline and Endpoint
Left leg - Baseline
28.0 kg
Standard Deviation 7.9
Quadriceps Strength at Baseline and Endpoint
Left Leg - Endpoint
29.9 kg
Standard Deviation 6.9

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

FRAIL scale: fatigability, resistance, ambulation, illnesses, loss of weight. If the answers to any of the questions is yes, then given score is "1" with a total survey range of 0 to 5. Higher scores represent greater frailty.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
FRAIL Scale Survey at Baseline and Endpoint
Baseline
0.2 Score on a scale
Standard Deviation 0.4
FRAIL Scale Survey at Baseline and Endpoint
Endpoint
0.1 Score on a scale
Standard Deviation 0.3

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Interleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Serum Interleukin-6 Level at Baseline and Endpoint
Baseline
3.8 pg/mL
Standard Deviation 1.9
Serum Interleukin-6 Level at Baseline and Endpoint
Endpoint
4.2 pg/mL
Standard Deviation 2.4

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Interleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Serum Interleukin-10 Level at Baseline and Endpoint
Baseline
3.0 pg/mL
Standard Deviation 0.9
Serum Interleukin-10 Level at Baseline and Endpoint
Endpoint
3.1 pg/mL
Standard Deviation 1.2

SECONDARY outcome

Timeframe: baseline and at participant completion, an average of 3 months

Population: The goal of this project was to determine if raw functional near infrared spectroscopy data could be collected in participants. Data collection was verified. This work lays the foundation for future efforts in new experiments to determine methods to analyze the raw data to generate understandable data for interpretation - and lead to better understanding of the impacts of exercise on blood flow in muscle tissue.

Seeking to collect raw data using functional near infra-red spectroscopy to analyze quadriceps during VO2max test. This work is the first steps in the development of techniques that analyze muscle blood flow and tissue oxygenation during exercise.

Outcome measures

Outcome measures
Measure
HIIT Intervention
n=23 Participants
Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle. Short session HIIT: Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
Number of Participants With Muscle Tissue Oxygenation Raw Data Collected
10 Participants

Adverse Events

HIIT Intervention

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

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bruce Troen

VA Kansas City Healthcare System

Phone: 913-574-4896

Results disclosure agreements

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