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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how different types of exercise can improve strength and overall health in older adults. It combines endurance activities (like walking or cycling) and resistance training (such as weight lifting) to assess individual responses and identify the best ways to enhance physical fitness. Ideal participants are those aged 60 or above who have not followed a regular exercise routine in the past year and are free from chronic diseases that might interfere with exercise. As an unphased trial, this study offers a unique opportunity to discover personalized exercise benefits and improve health.

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 prior data suggests that this exercise training is safe for older adults?

Research shows that combining endurance and resistance exercises is generally safe for older adults. Studies have found that resistance training boosts muscle strength and stability in older people with sarcopenia, a condition that leads to muscle loss. It also enhances body composition and daily activity performance.

Further research suggests that adding aerobic exercises or nutritional supplements to resistance training might offer additional benefits. This combination helps older adults increase their strength and functional ability, even for those with heart issues.

Overall, this approach is well-tolerated and offers many health benefits, making it an excellent option for improving fitness and quality of life in older adults. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a unique approach to tackling sarcopenia through a combination of endurance and resistance training tailored to individual responsiveness. Unlike standard treatments that may focus on nutrition or general exercise, this trial aims to boost exercise training based on specific categories of responsiveness. By adjusting the training intensity and providing education on wearable device data, this method could offer more personalized and effective solutions for improving muscle function and fitness in older adults.

What evidence suggests that this trial's exercise training could be effective for sarcopenia?

This trial will evaluate the effects of combined endurance and resistance training on sarcopenia. Studies have shown that combining endurance and resistance exercises benefits older adults with sarcopenia, a condition that causes muscle loss and weakness. Research indicates that resistance exercises improve muscle strength, body composition, and daily task performance. Additionally, combining resistance exercises with aerobic activities or nutritional supplements yields better results than resistance exercises alone. One study found that a mixed exercise program could enhance daily activities, even with just 10 sessions. Overall, these findings suggest that combining different types of exercises can improve strength and physical abilities in older adults experiencing muscle decline. ^{1 3 6 7 8}

Who Is on the Research Team?

Marcas Bamman

Principal Investigator

Florida Institute for Human and Machine Cognition

Are You a Good Fit for This Trial?

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 do not have any long-term illnesses.

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

I am 60 years old or older.

Exclusion Criteria

Life expectancy < 1 year

Lidocaine allergy

I do not have any current infections.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10638274/

Effects of resistance training on muscular strength ... Results indicate, RT improves body composition (p = 0.001), functional performance (p 0.001), postural stability (p = 0.005) and muscle strength (p 0.001) in ...

2. bmcgeriatr.biomedcentral.com bmcgeriatr.biomedcentral.com/articles/10.1186/s12877-021-02642-8

Effects of different exercise training modes on muscle strength ... In older people with sarcopenia, KES and GS can be improved by RT and MT, but not by WBVT. All three training modes improved TUG times, but not improved CS ...

3. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2022.1037464/full

Effects of different intervention combined with resistance ... Conclusion: Resistance Training combined with Aerobic Training or nutritional supplements has better effects than Resistance Training alone in older male adults ...

4. e-epih.org e-epih.org/journal/view.php?number=1496

a systematic review and meta-analysis The results demonstrated that the combined intervention of protein supplementation and resistance exercise significantly increased muscle mass.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1279770723003822

Effectiveness of a Short-Term Mixed Exercise Program for ... Our study demonstrated that a mixed exercise program, even as short as 10 sessions over two weeks, was valuable for improving the ADL of sarcopenic inpatients ...

6. academic.oup.com academic.oup.com/ageing/article/51/2/afac003/6527381

Resistance exercise as a treatment for sarcopenia Resistance exercise programmes should consist of two full-body exercise sessions per week performed with a relatively high degree of effort.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405525525000305

Review article Sarcopenia prevention in older adults This review provides an overview of the effectiveness of exercise, nutrition, and electrical muscle stimulation (EMS) in preventing sarcopenia.

8. journals.lww.com journals.lww.com/nsca-jscr/fulltext/2019/08000/resistance_training_for_older_adults__position.1.aspx

Resistance Training for Older Adults: Position Statement... In addition, resistance training combined with endurance training in older coronary heart patients results in enhanced strength and function (270,282).