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CompletedNCT03771417REALPAUpdated Mar 19, 2025Results posted

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

An interventional study of Exercise Intervention in Aging, Sarcopenia and Disability Physical, sponsored by Louisiana State University and A&M College. Completed at 2 sites in United States. Open to participants aged 65 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Louisiana State University and A&M College · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
65 Years to 80 Years
Sex
All
01

Study 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?

Read the 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.

02

Conditions studied

  • Aging
  • Sarcopenia
  • Disability Physical
  • Cardiovascular Diseases
  • Insulin Resistance
  • Diabetes Mellitus
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's enrollment of 24 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Louisiana State University and A&M College is the lead sponsor of 13 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years to 80 Years
Sexes eligible
All
Accepts 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.

Exclusion criteria

Exclusion Criteria:

  1. Nursing home resident
  2. Physically Active:

    a. > 100 min/wk of moderate OR > 50 min/wk vigorous intensity PA

  3. Saint Louis University Mental State (SLUMS) score \< 21
  4. Evidence or self-report history of deep vein thrombosis, pulmonary embolism, cardiovascular, peripheral vascular, cerebral vascular, pulmonary, or renal disease
  5. Evidence or self-report history of type 1 or 2 diabetes mellitus
  6. Evidence or self-report history of a bleeding disorder
  7. Evidence or self-report history of recurrent vasovagal episodes
  8. Evidence or self-report history of severe depression, Schizophrenia, bipolar disease
  9. Evidence or self-report history of mobility disability requiring a walker, wheel chair, or inability to walk across a small room.
  10. Evidence or self-report history of orthopedic limitations that would preclude them from participation in a dynamic exercise program
  11. Evidence or self-report history of severe arthritis (either osteoarthritis or rheumatoid arthritis) that would preclude them from participation in a dynamic exercise program
  12. Evidence or self-report of history untreated thyroid dysfunction.
  13. Weight loss of > 10% in the last 3 months prior to screening
  14. History of weight loss surgery.
  15. Use of medications known to influence study outcomes, such as:

    1. Insulin
    2. Oral antidiabetic medications (e.g., metformin)
    3. Corticosteroids
    4. Beta-blockers

    c. Anticoagulants

  16. Allergy to lidocaine
  17. Active smoking
  18. Current consumption of > 14 alcoholic drinks per week based on self-report
  19. Regular participation in resistance or aerobic exercise training within 3 months of initial screening
  20. Absolute Contraindication to Exercise as Defined by the American College of Sports Medicine,16 including:

    1. Resting diastolic blood pressure > 100 mm Hg
    2. Resting systolic blood pressure > 180 mm Hg
    3. Resting heart rate > 100 beats per min
  21. Having a body weight greater than 440 pounds
  22. Having medical implants such as a pacemaker or metal joint replacements
  23. Having tattoos or permanent makeup completed \<30 days prior to the visit
  24. Recent (past 3 months) cancer diagnosis, undergoing immunotherapy, taking immune suppressants
  25. Presence of allergies or infections requiring antibiotics within the past 14 days
  26. Recent (past 3 months) major surgery on the abdomen, pelvis, or lower extremities
  27. Any other condition that in the judgement of the Principal Investigator and/or the Medical Director of this protocol may interfere with study participation and adherence to the protocol.
  28. Evidence or self-report history of severe depression in the last 5 years.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Resistance Exercise

    Exercise Intervention: Participants will be asked to complete supervised resistance exercise 2 days per week.

    Behavioral: Exercise Intervention

  • Experimental
    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 \[6x10 min breaks/d at 2 metabolic equivalents (METS) or \~30-40% peak oxygen consumption (VO2 peak), \~500 kcal/wk above resting metabolism\].

    Behavioral: Exercise Intervention

  • Active comparator
    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).

    Behavioral: Exercise Intervention

Interventions

  • BehavioralExercise Intervention

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

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

07

Results

Posted Mar 19, 2025

Participant flow

Participant flow — Overall Study
MilestoneResistance ExerciseRE Plus Low Intensity Physical ActivityRE Plus Moderate Intensity Exercise
Started788
Completed678
Not completed110
Withdrew: Withdrawal by subject100
Withdrew: Covid-19 shutdown010

Outcome measures

PrimarySkeletal 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
Reported as:
Mean · Change in Lbs
Skeletal Muscle Strength
Change in LbsResistance ExerciseRE Plus Moderate Intensity ExerciseRE Plus Low Intensity Physical Activity
Skeletal Muscle Strength93.9 ± 17.950.0 ± 15.278.6 ± 15.2
PrimarySkeletal 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
Reported as:
Mean · Change Appendicular Lean Mass (kg/m^2)
Skeletal Muscle Mass
Change Appendicular Lean Mass (kg/m^2)Resistance ExerciseRE Plus Moderate Intensity ExerciseRE Plus Low Intensity Physical Activity
Skeletal Muscle Mass0.22 ± 0.110.17 ± 0.100.27 ± 0.10
SecondaryMitochondrial 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
Reported as:
Least squares mean · pmols/sec/mg wet weight
Mitochondrial Function
pmols/sec/mg wet weightResistance ExerciseRE Plus Low Intensity Physical ActivityRE Plus Moderate IntensityExercise
Mitochondrial Function27.2 ± 5.917.0 ± 5.45.9 ± 8.3

Adverse events

Collected over During study period, up to 16 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Resistance Exercise0/7 (0%)0/7 (0%)0/7 (0%)
RE Plus Moderate Intensity Exercise0/8 (0%)0/8 (0%)0/8 (0%)
RE Plus Low Intensity Physical Activity0/8 (0%)0/8 (0%)2/8 (25%)
Most frequent other events
Most frequent other events
EventResistance ExerciseRE Plus Moderate Intensity ExerciseRE Plus Low Intensity Physical Activity
FallInvestigations0/70/81/8
VasovagalCardiac disorders0/70/81/8

Baseline characteristics

One participant in the resistance training group withdrew from the study due to time conflict, and one participant in the RE plus Low Intensity Physical Activity was lost to follow-up due to shutdown of campus during the beginning of the covid 19 pandemic.

Age, Continuous
Age, Continuous(years)Resistance ExerciseRE Plus Low Intensity Physical ActivityRE Plus Moderate IntensityExerciseTotal
Mean70.3 ± 2.970.4 ± 3.969.5 ± 5.070.0 ± 3.9
Sex: Female, Male
Sex: Female, Male(Participants)Resistance ExerciseRE Plus Low Intensity Physical ActivityRE Plus Moderate IntensityExerciseTotal
Female56516
Male2237
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Resistance ExerciseRE Plus Low Intensity Physical ActivityRE Plus Moderate IntensityExerciseTotal
American Indian or Alaska Native0000
Asian0000
Native Hawaiian or Other Pacific Islander0000
Black or African American2114
White57719
More than one race0000
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Resistance ExerciseRE Plus Low Intensity Physical ActivityRE Plus Moderate IntensityExerciseTotal
United States78823
08

Study locations

2 sites
  • Lousiana State University
    Baton Rouge, Louisiana 70803, United States
  • Pennington Biomedical Research Center
    Baton Rouge, Louisiana 70808, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Apr 30, 2021

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03771417
Lead sponsor
Louisiana State University and A&M College
Collaborators
Pennington Biomedical Research Center, National Institute on Aging (NIA)
Responsible party
Brian Irving (Associate Professor, Louisiana State University and A&M College) — Principal investigator
First posted
Dec 11, 2018
Start date
Jan 16, 2019
Primary completion
Feb 9, 2023
Completion
Feb 9, 2023
Results posted
Mar 19, 2025
Last update
Mar 19, 2025

Study contacts

Brian Irving, PhD
principal investigator · Louisiana State University and A&M College

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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