NCT03771417: REALPA

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

Completed NA Results posted Last updated 19 March 2025

What this trial tests

NA trial testing Exercise Intervention in Aging in 24 participants. Completed in 9 February 2023.

Timeline

16 January 2019

Primary endpoint
9 February 2023

9 February 2023

Quick facts

Lead sponsor	Louisiana State University and A&M College
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	24
Start date	16 January 2019
Primary completion	9 February 2023
Estimated completion	9 February 2023
Sites	2 locations across United States

Drugs / interventions tested

• Exercise Intervention

Conditions studied

• Aging — all drugs for Aging →
• Sarcopenia — all drugs for Sarcopenia →
• Disability Physical — all drugs for Disability Physical →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

Louisiana State University and A&M College

Who can join

Adults 65 to 80, any sex, with Aging or Sarcopenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Skeletal Muscle Strength Primary · Measured at week 0 (baseline) and week 16

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.

Group	Value	95% CI
Resistance Exercise	93.9	± 17.9
RE Plus Moderate Intensity Exercise	50.0	± 15.2
RE Plus Low Intensity Physical Activity	78.6	± 15.2

Skeletal Muscle Mass Primary · Measured at week 0 (baseline) and week 16

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.

Group	Value	95% CI
Resistance Exercise	0.22	± 0.11
RE Plus Moderate Intensity Exercise	0.17	± 0.10
RE Plus Low Intensity Physical Activity	0.27	± 0.10

Mitochondrial Function Secondary · Measured at week 0 (baseline) and week 16

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.

Group	Value	95% CI
Resistance Exercise	27.2	± 5.9
RE Plus Low Intensity Physical Activity	17.0	± 5.4
RE Plus Moderate IntensityExercise	5.9	± 8.3

Adverse events — posted to ClinicalTrials.gov

Time frame: During study period, up to 16 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Resistance Exercise

Serious: 0/7 (0%)

Deaths: 0/7

RE Plus Moderate Intensity Exercise

Serious: 0/8 (0%)

Deaths: 0/8

RE Plus Low Intensity Physical Activity

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (2 terms — click to expand)

Reaction	System	Resistance Exercise	RE Plus Moderate Intensity…	RE Plus Low Intensity Phys…
Fall	Investigations	—	—	—
Vasovagal	Cardiac disorders	—	—	—

Data from ClinicalTrials.gov NCT03771417 adverse events section.

Sponsor's own description

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?

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Shared mechanisms of multimorbidity in COPD, atherosclerosis and type-2 diabetes: the neutrophil as a potential inflammatory target.
   Hughes MJ, McGettrick HM, Sapey E. · · 2020 · cited 41× · PMID 32198215 · DOI 10.1183/16000617.0102-2019
2. Smartphone prediction of skeletal muscle mass: model development and validation in adults.
   McCarthy C, Tinsley GM, Yang S, Irving BA, et al · · 2023 · cited 25× · PMID 36822238 · DOI 10.1016/j.ajcnut.2023.02.003
3. Monitoring body composition change for intervention studies with advancing 3D optical imaging technology in comparison to dual-energy X-ray absorptiometry.
   Wong MC, Bennett JP, Leong LT, Tian IY, et al · · 2023 · cited 19× · PMID 36796647 · DOI 10.1016/j.ajcnut.2023.02.006
4. Senescence and Type 2 Diabetic Cardiomyopathy: How Young Can You Die of Old Age?
   Henson SM, Aksentijevic D. · · 2021 · cited 17× · PMID 34690759 · DOI 10.3389/fphar.2021.716517
5. Advances in digital anthropometric body composition assessment: neural network algorithm prediction of appendicular lean mass.
   Marazzato F, McCarthy C, Field RH, Nguyen H, et al · · 2024 · cited 5× · PMID 38142263 · DOI 10.1038/s41430-023-01396-3