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.
TERMINATED
NA
42 participants
baseline and at participant completion, an average of 3 months
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
| 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
| 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
| 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 months6-minute walk, total distance over 6 minutes in a 50 foot long hallway, participants asked to walk at a "brisk" pace.
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 monthsPopulation: 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
| 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 monthsPopulation: 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
| 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 monthsShort 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
| 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 monthsFried 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
| 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 monthsQuality 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
| 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 monthsPopulation: 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
| 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 monthsThe 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
| 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 monthsPopulation: 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: baselinePopulation: 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
| 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 monthsC-reactive protein was measured from isolated serum samples at baseline and endpoint using ELISA
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 monthsPopulation: 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
| 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 monthsFRAIL 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
| 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 monthsInterleukin-6 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA
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 monthsInterleukin-10 collected from serum extracted from blood samples taken at baseline and endpoint and measured using ELISA
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 monthsPopulation: 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
| 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 adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place