Trial Outcomes & Findings for Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health (NCT NCT03771417)
NCT ID: NCT03771417
Last Updated: 2025-03-19
Results Overview
The investigators will determine the change from baseline in skeletal muscle strength. These measurements will be performed at baseline and following 16 weeks of exercise training using isokinetic dynamometry and 1 repetition maximum testing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
Measured at week 0 (baseline) and week 16
Results posted on
2025-03-19
Participant Flow
24 participants were enrolled in the present study, 23 participants were randomized. 1 participant did not complete baseline testing.
Participant milestones
| Measure |
Resistance Exercise
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Low Intensity Physical Activity
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Moderate Intensity Exercise
Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (\~60-75% VO2 peak), \~500 kcal/week above resting metabolism).
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
|---|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
8
|
|
Overall Study
COMPLETED
|
6
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Resistance Exercise
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Low Intensity Physical Activity
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Moderate Intensity Exercise
Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (\~60-75% VO2 peak), \~500 kcal/week above resting metabolism).
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Covid-19 Shutdown
|
0
|
1
|
0
|
Baseline Characteristics
Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health
Baseline characteristics by cohort
| Measure |
Resistance Exercise
n=7 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Low Intensity Physical Activity
n=8 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Moderate IntensityExercise
n=8 Participants
Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (\~60-75% VO2 peak), \~500 kcal/week above resting metabolism).
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
70.3 years
STANDARD_DEVIATION 2.9 • n=99 Participants
|
70.4 years
STANDARD_DEVIATION 3.9 • n=107 Participants
|
69.5 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
70.0 years
STANDARD_DEVIATION 3.9 • n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
8 participants
n=107 Participants
|
8 participants
n=206 Participants
|
23 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Measured at week 0 (baseline) and week 16Population: Change is Leg Press 1-RM
The investigators will determine the change from baseline in skeletal muscle strength. These measurements will be performed at baseline and following 16 weeks of exercise training using isokinetic dynamometry and 1 repetition maximum testing.
Outcome measures
| Measure |
Resistance Exercise
n=6 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Moderate Intensity Exercise
n=8 Participants
Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (\~60-75% VO2 peak), \~500 kcal/week above resting metabolism).
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Low Intensity Physical Activity
n=7 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
|---|---|---|---|
|
Skeletal Muscle Strength
|
93.9 Change in Lbs
Standard Error 17.9
|
50.0 Change in Lbs
Standard Error 15.2
|
78.6 Change in Lbs
Standard Error 15.2
|
PRIMARY outcome
Timeframe: Measured at week 0 (baseline) and week 16Population: Change Appendicular Lean Mass (kg/m\^2)
The investigators will determine the change from baseline in skeletal muscle mass. These measurements will be performed at baseline and following 16 weeks of exercise training using Dual X-Ray Absorptiometry.
Outcome measures
| Measure |
Resistance Exercise
n=6 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Moderate Intensity Exercise
n=8 Participants
Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (\~60-75% VO2 peak), \~500 kcal/week above resting metabolism).
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Low Intensity Physical Activity
n=7 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
|---|---|---|---|
|
Skeletal Muscle Mass
|
0.22 Change Appendicular Lean Mass (kg/m^2)
Standard Error 0.11
|
0.17 Change Appendicular Lean Mass (kg/m^2)
Standard Error 0.10
|
0.27 Change Appendicular Lean Mass (kg/m^2)
Standard Error 0.10
|
SECONDARY outcome
Timeframe: Measured at week 0 (baseline) and week 16Population: Change skeletal muscle oxidative capacity measured using high-resolution respirometry in permeabilized muscle fibers for complex I and II substrates (pyruvate, malate, glutamate, and succinate) expressed as pmols/sec/mg wet weight.
The investigators will determine the change from baseline in mitochondrial function. These measurements will be performed at baseline and following 16 weeks of exercise training.
Outcome measures
| Measure |
Resistance Exercise
n=6 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Moderate Intensity Exercise
n=7 Participants
Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (\~60-75% VO2 peak), \~500 kcal/week above resting metabolism).
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Low Intensity Physical Activity
n=3 Participants
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
|---|---|---|---|
|
Mitochondrial Function
|
27.2 pmols/sec/mg wet weight
Standard Error 5.9
|
17.0 pmols/sec/mg wet weight
Standard Error 5.4
|
5.9 pmols/sec/mg wet weight
Standard Error 8.3
|
Adverse Events
Resistance Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RE Plus Moderate Intensity Exercise
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RE Plus Low Intensity Physical Activity
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 |
Resistance Exercise
n=7 participants at risk
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Moderate Intensity Exercise
n=8 participants at risk
Exercise Intervention: Participants will be asked to complete supervised RE 2 days per week and supervised calorically matched moderate intensity physical activity 3 days per week (50 min/session at 4 METS (\~60-75% VO2 peak), \~500 kcal/week above resting metabolism).
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
RE Plus Low Intensity Physical Activity
n=8 participants at risk
Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week and regular unsupervised low intensity physical activity breaks in sedentary time 5 days per week \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].
Exercise Intervention: The use of exercise to improve muscle and cardiometabolic health in older adults.
|
|---|---|---|---|
|
Investigations
Fall
|
0.00%
0/7 • During study period, up to 16 weeks
|
0.00%
0/8 • During study period, up to 16 weeks
|
12.5%
1/8 • Number of events 1 • During study period, up to 16 weeks
|
|
Cardiac disorders
Vasovagal
|
0.00%
0/7 • During study period, up to 16 weeks
|
0.00%
0/8 • During study period, up to 16 weeks
|
12.5%
1/8 • Number of events 1 • During study period, up to 16 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place