Exercise Training for Metabolic Health in Aging

(BATSR Trial)

Overseen By Recruitment Department

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Translational Research Institute for Metabolism and Diabetes, Florida

Must not be taking: Anti-inflammatories, Corticosteroids, Anabolic agents, others

Disqualifiers: Diabetes, Hypertension, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how aging affects brown fat, a type of body fat that burns energy, in older adults who are either very active or mostly inactive. Participants will undergo various health assessments, such as exercise tests and body scans, to help researchers understand these effects. Suitable candidates are adults aged 65 to 90 who either regularly engage in endurance exercises like running or cycling or do less than one day of structured exercise a week. As an unphased trial, this study offers participants a unique opportunity to contribute to the scientific understanding of aging and energy metabolism.

Will I have to stop taking my current medications?

The trial requires participants to stop taking medications, dietary supplements, or substances that could affect glucose metabolism, are considered anabolic, or aid in weight loss starting two weeks before and throughout the study. However, if you are on stable doses of medications for blood pressure, cholesterol, or GERD, you may be allowed to continue them.

What prior data suggests that these interventions are safe for older adults?

Research shows that exercise is generally safe for older adults. Studies have found that exercising at home can help reduce physical weakness in this population. These programs are easy to follow and can improve strength, balance, and flexibility.

Researchers have tested exercise programs in various settings, such as at home or outdoors, using tools like activity trackers. These studies did not identify any major safety issues, suggesting that exercise is safe for most older adults.

In summary, exercise appears to be a safe and effective way to improve health in older adults. Following the program as instructed is important to minimize potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how exercise impacts metabolic health in older adults, focusing on both athletes and those who are sedentary. Unlike traditional treatments that might include medication or dietary changes to manage metabolic health, this study looks at physical activity as a direct intervention. Key features include using advanced techniques like the hyperinsulinemic-euglycemic clamp and MRI to precisely measure metabolic changes. This approach could reveal how different exercise regimens affect metabolism and help design more effective, personalized exercise plans for aging individuals.

What evidence suggests that this trial's treatments could be effective for metabolic health in aging?

This trial will compare the effects of exercise training on metabolic health in aging between two groups: older adults regularly engaged in endurance exercise (OA - Older Athlete) and older adults who are sedentary (OS - Older Sedentary). Research has shown that exercise can improve physical abilities in older adults. Studies have found that exercise programs, especially those with strength training, increase leg strength and overall fitness. Specifically, strength and aerobic exercises enhance physical performance in older people. These exercises are generally safe and help prevent weakness. Overall, exercise programs hold promise for improving health and physical abilities as people age. ^{1 2 6 7 8}

Who Is on the Research Team?

Paul Coen, PhD

Principal Investigator

Study Principal Investigator

Are You a Good Fit for This Trial?

The BATSR trial is for men and women aged 65-90 with stable weight, non-smokers, not on certain medications or pursuing weight loss. They must have specific cholesterol levels, normal kidney function (eGFR > 45), a BMI up to 35kg/m2, no recent significant weight changes, and be able to follow the study protocol.

Inclusion Criteria

BMI 35kg/m2, inclusive at time of screening.

My kidney function is good, with an eGFR over 45.

I have not smoked or used nicotine products, including vapes, in the last 3 months.

Exclusion Criteria

I cannot undergo MRI or DEXA scans due to physical size, claustrophobia, or doctor's advice.

My medication for blood pressure, cholesterol, or GERD has been stable for the last 30 days.

I have a chronic infectious disease like TB, Hepatitis B/C, or HIV.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Initial assessment of brown adipose tissue mass and metabolic function

1 week

Observation

Participants are observed for changes in brown adipose tissue mass and metabolic function

8 weeks

4 days per week, 30 minutes

Follow-up

Participants are monitored for safety and effectiveness after the observation period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Dual Energy X-Ray Absorptiometry (DEXA)
• Exercise Training Intervention
• Handgrip strength test
• Hyperinsulinemic-euglycemic clamp
• Lower extremity performance battery
• MRI
• Post-Intervention Testing
• Resting Metabolic Rate/Respiratory Quotient (RMR/RQ)
• Step Test
• V02 max test/stress test

Trial Overview This study tests how exercise affects brown adipose tissue in older adults. Participants will engage in an exercise training intervention designed to assess changes in metabolic and cardiac health related to aging.

How Is the Trial Designed?

Group I: OA- Older Athlete Active Control 1 Intervention

Older adults who are regularly engaged in endurance exercise

Group II: OS- Older Sedentary Active Control 1 Intervention

Older adults who are sedentary

Who Is Running the Clinical Trial?

Translational Research Institute for Metabolism and Diabetes, Florida

Lead Sponsor

Trials

41

Recruited

3,600+

AdventHealth Translational Research Institute

Lead Sponsor

Trials

51

Recruited

5,900+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Regular physical activity significantly reduces the risk of developing impaired glucose tolerance and non-insulin-dependent diabetes mellitus (NIDDM), especially in individuals at high risk, as supported by various epidemiological and aging studies.

Exercise training, particularly vigorous and prolonged protocols, can improve insulin sensitivity and glucose tolerance by increasing muscle insulin action and promoting beneficial changes in muscle morphology, such as increased capillary density and the conversion of muscle fiber types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of exercise training in the prevention and treatment of insulin resistance and non-insulin-dependent diabetes mellitus. Ivy, JL.[2022]

A 24-week moderate exercise program (60 minutes, 3 days a week) significantly improved aerobic capacity in 14 sedentary elderly males, indicating that regular exercise can enhance physical fitness in older adults.

The training also led to a reduction in serum α-MSH and thyroid hormones (T3 and T4) after 6 months, suggesting that moderate exercise positively influences metabolic profiles and hormonal balance in the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic exercise promotes alterations in the neuroendocrine profile of elderly people. Alves, ES., Souza, HS., Rosa, JP., et al.[2012]

Exercise training (ET) for 9 months significantly improved metabolic parameters, such as hemoglobin A1c and measures of body fat, in participants with type 2 diabetes, regardless of whether they improved their cardiorespiratory fitness (CRF).

Both fitness responders and nonresponders experienced similar benefits in metabolic health, indicating that ET can be effective even for those who do not show significant increases in cardiorespiratory fitness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Effects of Exercise Training Among Fitness-Nonresponsive Patients With Type 2 Diabetes: The HART-D Study. Pandey, A., Swift, DL., McGuire, DK., et al.[2022]

Resistance training (RT) is the only non-drug method proven to effectively counteract age-related declines in muscle mass, strength, and power, while also reducing risks of various health issues like cardiovascular disease and depression.

Minimal-dose RT strategies, which involve lower training volumes and can be performed with minimal equipment, are effective in improving strength and functional ability, making it easier for more people to participate and potentially enhancing overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal-Dose Resistance Training for Improving Muscle Mass, Strength, and Function: A Narrative Review of Current Evidence and Practical Considerations. Fyfe, JJ., Hamilton, DL., Daly, RM.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9642810/

Effectiveness of home-based exercise delivered by digital ... The HBE programmes carried out by DHI improve physical function in terms of lower extremity strength and functional capacity.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7858023/

Exercise interventions for older adults: A systematic review ... The largest effect sizes for improvement were found for resistance training, meditative movement interventions, and exercise-based active videogames.

3. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-024-05393-4

The effectiveness of unsupervised home-based exercise for ... This meta-analysis suggests that unsupervised home-based exercise programmes have little impact on lower extremity functions in older adults.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2260134124003918

Home-Based Exercise Programs for the Oldest-Old to ... These home interventions demonstrated potential, safety and effectiveness in preventing and alleviating physical frailty, adherence in most studies varied ...

5. nature.com nature.com/articles/s41598-025-11076-w

Effects of resistance training and aerobic ... This study investigated the effectiveness of a resistance and aerobic training model among 71 middle-aged participants aged 30–60 (mean age ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11528160/

Protocol of the HEAL Sepsis Randomized Clinical Trial This study is the first to use a home-based, remotely monitored 12-week exercise program to improve physical function in sepsis survivors. This study will ...

7. paahjournal.com paahjournal.com/articles/10.5334/paah.122

'Prime Time of Life', A 12-Week Home-Based Online ... Twelve weeks of online multimodal training and health education can significantly improve cardiovascular fitness, strength, power, balance, flexibility, and ...

8. mhealth.jmir.org mhealth.jmir.org/2025/1/e69259

Outdoor Exercise Facility–Based Integrative Mobile Health ... For instance, a 14-week exercise intervention that used wearable activity trackers and incorporated behavioral change techniques for older ...