Exercise Training for Sarcopenia

(M3AX Trial)

Recruiting at 1 trial location

Overseen By Craig Tuggle

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Florida Institute for Human and Machine Cognition

Must not be taking: Insulin sensitizers, High-dose statins

Disqualifiers: Neuromuscular, Cardiopulmonary, Metabolic, others

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

Compensation: Varies

Number of Visits: Unknown

250 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking insulin sensitizing or blood glucose lowering agents like metformin, or high dose lipophilic statins (40 mg or more per day).

What data supports the effectiveness of the treatment Combined endurance and resistance training for sarcopenia?

Research shows that resistance exercise training can be effective against sarcopenia, and exercise interventions improve body composition and physical function in older adults with sarcopenia. ^{1 2 3 4 5}

Is exercise training safe for people with sarcopenia?

Exercise interventions for sarcopenia in older adults have been studied and found to improve muscle strength and walking speed without significant safety concerns reported. These studies suggest that exercise is generally safe for improving physical function in this population. ^{2 3 6 7 8}

How does combined endurance and resistance training differ from other treatments for sarcopenia?

Combined endurance and resistance training is unique because it integrates both aerobic exercises, which improve cardiovascular health, and resistance exercises, which are known to increase muscle strength and mass. This dual approach may offer more comprehensive benefits for older adults with sarcopenia compared to treatments focusing solely on resistance training. ^{1 2 9 10 11}

What is the purpose of this trial?

Aging-related functional declines are thought to be caused by hallmark biological processes that ultimately manifest in physical, mental, and metabolic impairments that compromise healthspan and quality of life. Exercise is a multipotent treatment with promise to mitigate most aging hallmarks, but there is substantial variability in exercisƒe responsiveness. Combining endurance and resistance training in alignment with public health guidelines will be used to better understand variable exercise responsiveness in older adults with the ultimate goal of improving each older adult's capacity to attain the many health benefits of exercise.

Research Team

Marcas Bamman

Principal Investigator

Florida Institute for Human and Machine Cognition

Eligibility Criteria

This trial is for older adults who are experiencing muscle loss and weakness, known as sarcopenia. Participants should be interested in following a combined program of endurance and resistance training according to public health guidelines.

Inclusion Criteria

I am 60 years old or older.

I do not have any long-term illnesses.

No structured exercise program (2 or more bouts/wk) within previous 12 months

Exclusion Criteria

Life expectancy < 1 year

Lidocaine allergy

I do not have any current infections.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Interrogation

Participants undergo exercise training using a prescription in accordance with public health recommendations. At the end of this phase, participants are classified into categories based on their responsiveness.

12 weeks

Regular exercise sessions

Mitigation

Exercise training is boosted for nonresponsive groups, with additional education on wearable device data and lifestyle recommendations.

11 weeks

Regular exercise sessions and educational visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Combined endurance and resistance training

Trial Overview The study is testing how effective a combination of endurance and resistance exercises can be in improving the health and physical capabilities of older adults with sarcopenia. It aims to understand why people respond differently to exercise.

Participant Groups

Group I: Mitigation Experimental Treatment 1 Intervention

Based on these categories of responsiveness, exercise training will be boosted in the three groups that are nonresponsive in one or both outcomes. CRF-/fMQ+ will receive boosted ET, CRF+/fMQ- will receive boosted RT, and CRF-/fMQ- will receive boosting in both. All three of these classifications will also receive education on wearable device data and other free-living recommendations four times during Mitigation

Group II: Interrogation Experimental Treatment 1 Intervention

In Interrogation, all participants will exercise train using an exercise prescription that is in accordance with current public health recommendations19. At the end of Phase I participants will be classified into one of the four categories listed in Fig. A: (1) CRF-/fMQ-, 2) CRF-/fMQ+, 3) CRF+/fMQ- and 4) CRF+/fMQ+).

Who Is Running the Clinical Trial?

Florida Institute for Human and Machine Cognition

Lead Sponsor

Trials

6

Recruited

540+

University of Florida

Collaborator

Trials

1,428

Recruited

987,000+

Oklahoma Medical Research Foundation

Collaborator

Trials

24

Recruited

8,400+

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Treatment indications for sarcopenia: a systematic review of exercise intervention effect]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Gender, Success, and Drop-Out during a Resistance Exercise Program in Community Dwelling Old Adults. [2020]

3. Australia pubmed.ncbi.nlm.nih.gov

Exercise interventions in healthy older adults with sarcopenia: A systematic review and meta-analysis. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the Usefulness of Consensus Definitions of Sarcopenia in Older Men: Results from the Observational Osteoporotic Fractures in Men Cohort Study. [2022]

5. Japan pubmed.ncbi.nlm.nih.gov

[Interventions for frailty and sarcopenia in community-dwelling elderly women]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effects of exercise and/or β-hydroxy-β-methylbutyrate supplementation on muscle mass, muscle strength, and physical performance in older women with low muscle mass: a randomized, double-blind, placebo-controlled trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Assessment of Sarcopenia Among Community-Dwelling At-Risk Frail Adults Aged 65 Years and Older Who Received Multidomain Lifestyle Interventions: A Secondary Analysis of a Randomized Clinical Trial. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Systematic Review and Meta-Analysis of Exercise Beneficial for Locomotion in Community-Dwelling Elderly People with Sarcopenia. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Effects and Moderators of Exercise on Sarcopenic Components in Sarcopenic Elderly: A Systematic Review and Meta-Analysis. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Moderate Intensity Resistive Training Reduces Oxidative Stress and Improves Muscle Mass and Function in Older Individuals. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Resistance exercise as a treatment for sarcopenia: prescription and delivery. [2022]