Exercise Intervention for Obesity and Sarcopenia

(ENHANCE Trial)

Overseen By Olivia Porcello, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Hypertension, Home oxygen, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older Veterans with obesity and low muscle mass (sarcopenia) reduce their risk of falls. Participants will either join a virtual exercise program combined with health education (Health Promotion With Targeted Exercise Intervention) or receive health education alone. The study will compare the two groups to determine if adding exercise more effectively prevents falls and improves daily activity. Ideal candidates are Veterans over 55 with obesity and signs of sarcopenia, enrolled in the VA Maryland Health Care System.

As an unphased trial, this study offers Veterans a unique opportunity to contribute to innovative research that could enhance their health and well-being.

Do I need to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this exercise intervention is safe for older Veterans with obesity and sarcopenia?

Research shows that exercise programs are generally safe and effective for older adults, including those who are overweight or have low muscle strength. Studies have found that exercise routines, especially those lasting eight weeks or more, can increase muscle strength and decrease body fat, indicating participants handle them well.

One study found that exercise significantly lowered body mass index (BMI) and body fat percentage. Another study showed that resistance exercises improved grip strength and reduced body fat in older adults with low muscle strength and obesity. Additionally, exercise programs have enhanced physical abilities and reduced the risk of falls in older adults.

Overall, these findings suggest that the exercise program in this trial is likely safe and beneficial for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the exercise intervention for obesity and sarcopenia because it combines targeted exercise with health education in a unique way. Unlike standard treatments that may focus solely on diet or medication, this approach integrates a live virtual fall-prevention exercise program with health promotion education. This combination not only aims to improve physical strength and prevent falls but also empowers participants with the knowledge to make healthier lifestyle choices. The accessibility of a virtual platform makes it easier for individuals to participate consistently, potentially leading to better long-term outcomes.

What evidence suggests that this exercise intervention is effective for reducing fall risk in older Veterans with obesity and sarcopenia?

Research shows that exercise can greatly improve muscle strength and physical ability in people with sarcopenia, a condition where muscles weaken with age. A review of studies confirms that exercise strengthens muscles, which is crucial for preventing falls. This trial will compare two approaches: one group will engage in a live virtual fall-prevention exercise intervention combined with a health promotion education program (EX + EDU), while another group will participate in a live virtual health promotion education program alone (EDU). Other studies indicate that combining exercise with good nutrition or health education leads to better results for those with sarcopenic obesity, a condition where obesity and low muscle mass occur together. One study found that structured exercise programs reduce obesity risk factors and aid in weight loss. Overall, these findings suggest that combining exercise with health education effectively reduces the risk of falls and improves daily activities in people with obesity and sarcopenia. ^{6 7 8 9 10}

Who Is on the Research Team?

Julie S Rekant, DPT PhD

Principal Investigator

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Are You a Good Fit for This Trial?

This trial is for aging Veterans who are overweight and show signs of sarcopenia, which means they have low muscle mass or strength. It's designed to help those at risk of falling and becoming less active. Participants should be able to attend virtual sessions but cannot join if certain conditions prevent them from safely exercising.

Inclusion Criteria

Veteran status

VA primary care provider

Enrolled in the VA Maryland Health Care System for health care

Exclusion Criteria

Home oxygen use

Contraindications to exercise or resistance exercise

Significant cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a live virtual fall-prevention exercise intervention plus a health promotion education program or a health promotion education program alone

12 weeks

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Promotion With Targeted Exercise Intervention

Trial Overview The study is examining whether a combination of fall prevention exercises and health education can reduce the risk of falls more effectively than health education alone in obese Veterans with sarcopenia. The program will be delivered virtually, focusing on safe exercise practices.

How Is the Trial Designed?

Group I: EX + EDU Experimental Treatment 2 Interventions

Participation in a live virtual fall-prevention exercise intervention plus a health promotion education program.

Group II: EDU Active Control 1 Intervention

Participation in a live virtual health promotion education program alone.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10985769/

Effectiveness of exercise interventions on muscle mass ... Previous research found that aerobic exercise had a significant effect on lowering obesity risk factors, despite the fact that resistance ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0197457225001855

Effectiveness of different types of exercise based- ... This meta-analysis supported the use of physical exercise to improve the physical performance and muscular strength of people with sarcopenia.

3. cdc.gov cdc.gov/pcd/issues/2024/23_0347.htm

Weight Loss in Short-Term Interventions for Physical ... This meta-analysis of 14 RCTs found that interventions lasting 6 months or less were effective at achieving weight loss. Each study showed ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10482763/

Effects of Nutrition and Exercise Interventions on Persons with ... Several clinical trials have shown that nutrition interventions and physical exercise improve relevant parameters regarding sarcopenic obesity ...

5. academic.oup.com academic.oup.com/heapro/article/37/3/daac061/6631503

Systematic review of the effectiveness of health promotion ... Post-intervention, 46.0% of all participants in this pre- and post-test study design reduced their BMI, along with reductions in blood pressure, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12595827/

Explore the optimal exercise intervention subtype for sarcopenia We hypothesized that resistance training (RT) would be the most effective exercise intervention subtype for sarcopenia, as it can increase ...

7. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1575580/full

Exercise interventions of ≥8 weeks improve body ... Exercise significantly reduced BMI (MD = −1.35, p < 0.0001), with combined exercise (CE) being the most effective (MD = −1.25, p < 0.001). Body fat percentage ...

8. journals.lww.com journals.lww.com/10.1097/jnr.0000000000000685

Effects of Resistance Exercise in Older Adults With... The findings support a positive effect of resistance exercise on grip strength and body fat percentage in older adults with sarcopenic obesity. Introduction.

9. sciencedirect.com sciencedirect.com/science/article/pii/S0197457223001416

Optimal exercise to improve physical ability and ... This article aims to summarize the effects of different forms of exercise on improving physical ability and performance in patients with sarcopenia by meta- ...

10. mdpi.com mdpi.com/2075-4663/13/5/152

The Effects of Exercise Intervention in Older Adults With ... Conclusions: Exercise interventions are effective in improving neuromuscular outcomes and reducing fall risk in older adults, both with and without sarcopenia.