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Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Muscle and Cardiometabolic Health

Resistance Exercise and Low-Intensity Physical Activity Breaks in Sedentary Time to Improve Skeletal Muscle and Cardiometabolic Health in Older Adults-REALPA Breaks in Sedentary Time Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03771417
Acronym
REALPA
Enrollment
24
Registered
2018-12-11
Start date
2019-01-16
Completion date
2023-02-09
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging, Cardiovascular Diseases, Diabetes Mellitus, Disability Physical, Insulin Resistance, Sarcopenia

Brief summary

What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal muscle health in older adults? What are the effects of resistance exercise (RE) alone or RE plus low intensity physical activity (LPA) breaks in sedentary time (ST) on skeletal cardiometabolic health in older adults?

Detailed description

Although awareness of the detrimental impact that sedentary behavior has on skeletal muscle and cardiometabolic health has increased over the last 20 years, more than 60% of older adults remain sedentary for greater than 8 hours per day. Moreover, 80% to 90% of adults 60 years of age or older do not meet the current public health guidelines for aerobic exercise (AE) or resistance exercise (RE) based physical activity (PA). Collectively, these adverse health behaviors contribute to the development of multiple chronic medical conditions commonly afflicting older adults, including type 2 diabetes, cardiovascular disease, sarco/dynapenia, frailty, and premature mortality. Emerging evidence suggests that breaking up sedentary time with light intensity PA (LPA) improves muscle and cardiometabolic health. Recent data also suggest that RE combined with moderate intensity AE effectively improves muscle and cardiometabolic health in older adults. However, the impact that RE combined with LPA breaks in sedentary time has on muscle and cardiometabolic health in older adults remains unknown. The overall objective of this pilot study is to determine the effect of 16 weeks of RE alone or RE combined with LPA breaks in sedentary time on muscle and cardiometabolic health.

Interventions

BEHAVIORALExercise Intervention

The use of exercise to improve muscle and cardiometabolic health in older adults.

Sponsors

Pennington Biomedical Research Center
CollaboratorOTHER
National Institute on Aging (NIA)
CollaboratorNIH
Louisiana State University and A&M College
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Are capable and willing to give written informed consent, and understand

Exclusion criteria

2. 65-80 years of age inclusive 3. Body Mass Index (BMI) between 18.5-34.9 kg/m2, inclusive 4. Physically inactive determined by self-report 5. Stable medical therapy for allowable medications for 30 days defined as: 1. No addition or removal of a medication 2. No change in dosage of a medication 6. Having no life-threatening conditions or diseases 7. Willing to allow researchers to use data, bio-specimens (blood and muscle tissue), and images (e.g., magnetic resonance imaging) for research purposes after study participation is completed 8. At least 2 weeks post-completion of the COVID19 vaccine regimen. a. Acceptable proof of vaccine includes a completed vaccine card and/or letter from a healthcare provider indicating the date that the COVID19 vaccine was completed.

Design outcomes

Primary

MeasureTime frameDescription
Skeletal Muscle StrengthMeasured at week 0 (baseline) and week 16The 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.
Skeletal Muscle MassMeasured at week 0 (baseline) and week 16The 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.

Secondary

MeasureTime frameDescription
Mitochondrial FunctionMeasured at week 0 (baseline) and week 16The investigators will determine the change from baseline in mitochondrial function. These measurements will be performed at baseline and following 16 weeks of exercise training.

Countries

United States

Participant flow

Pre-assignment details

24 participants were enrolled in the present study, 23 participants were randomized. 1 participant did not complete baseline testing.

Participants by arm

ArmCount
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.
7
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.
8
RE Plus Moderate IntensityExercise
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.
8
Total23

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyCovid-19 Shutdown010
Overall StudyWithdrawal by Subject100

Baseline characteristics

CharacteristicResistance ExerciseTotalRE Plus Moderate IntensityExerciseRE Plus Low Intensity Physical Activity
Age, Continuous70.3 years
STANDARD_DEVIATION 2.9
70.0 years
STANDARD_DEVIATION 3.9
69.5 years
STANDARD_DEVIATION 5
70.4 years
STANDARD_DEVIATION 3.9
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants4 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants19 Participants7 Participants7 Participants
Region of Enrollment
United States
7 participants23 participants8 participants8 participants
Sex: Female, Male
Female
5 Participants16 Participants5 Participants6 Participants
Sex: Female, Male
Male
2 Participants7 Participants3 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 70 / 80 / 8
other
Total, other adverse events
0 / 70 / 82 / 8
serious
Total, serious adverse events
0 / 70 / 80 / 8

Outcome results

Primary

Skeletal Muscle Mass

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.

Time frame: Measured at week 0 (baseline) and week 16

Population: Change Appendicular Lean Mass (kg/m\^2)

ArmMeasureValue (MEAN)Dispersion
Resistance ExerciseSkeletal Muscle Mass0.22 Change Appendicular Lean Mass (kg/m^2)Standard Error 0.11
RE Plus Moderate Intensity ExerciseSkeletal Muscle Mass0.17 Change Appendicular Lean Mass (kg/m^2)Standard Error 0.1
RE Plus Low Intensity Physical ActivitySkeletal Muscle Mass0.27 Change Appendicular Lean Mass (kg/m^2)Standard Error 0.1
Primary

Skeletal Muscle Strength

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.

Time frame: Measured at week 0 (baseline) and week 16

Population: Change is Leg Press 1-RM

ArmMeasureValue (MEAN)Dispersion
Resistance ExerciseSkeletal Muscle Strength93.9 Change in LbsStandard Error 17.9
RE Plus Moderate Intensity ExerciseSkeletal Muscle Strength50.0 Change in LbsStandard Error 15.2
RE Plus Low Intensity Physical ActivitySkeletal Muscle Strength78.6 Change in LbsStandard Error 15.2
Secondary

Mitochondrial Function

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.

Time frame: Measured at week 0 (baseline) and week 16

Population: 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.

ArmMeasureValue (LEAST_SQUARES_MEAN)Dispersion
Resistance ExerciseMitochondrial Function27.2 pmols/sec/mg wet weightStandard Error 5.9
RE Plus Moderate Intensity ExerciseMitochondrial Function17.0 pmols/sec/mg wet weightStandard Error 5.4
RE Plus Low Intensity Physical ActivityMitochondrial Function5.9 pmols/sec/mg wet weightStandard Error 8.3

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026