Focused Muscle Contraction Therapy for Veteran Wellbeing

Recruiting in Palo Alto (17 mi)

Overseen by Enrico Benedetti, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Illinois at Chicago

Disqualifiers: Travel limitations, Consent issues, Comprehension, Compliance

No Placebo Group

Trial Summary

What is the purpose of this trial?

This research study is being done to investigate if the GH Method exercise program positively affects body composition, improves physical abilities and can improve the overall sense of wellbeing (e.g. depression, PTSD, etc.) in U.S. Veterans. Subjects will be asked to complete 94 total visits (four (4) study testing visits and 90 exercise visits). Enrolled subjects will be tested for fitness, strength, and health risk factors at UIC 4 times and will complete 90 exercise training visits at the GH FITLab over the next 18 months. Subjects will also be asked to complete questionnaires about depression, post-traumatic stress symptoms and thoughts about harming oneself.

Will I have to stop taking my current medications?

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 data supports the effectiveness of the treatment Focused Muscle Contraction Therapy for Veteran Wellbeing?

Research shows that supervised exercise programs can improve cardiovascular fitness and psychological well-being in older veterans. For example, a study found significant improvements in treadmill performance and well-being scores after a 1-year exercise program. Additionally, exercise is recognized as beneficial for managing various chronic diseases, suggesting its potential effectiveness in enhancing veteran well-being. ^{1 2 3 4 5}

Is Focused Muscle Contraction Therapy safe for humans?

Exercise interventions, including resistance training and physical activity programs, are generally safe for humans. Serious adverse events are rare, though minor issues like muscle injuries can occur, especially in sedentary or older individuals. Starting with low intensity and gradually increasing can help minimize risks. ^{6 7 8 9 10}

How does the Focused Muscle Contraction Therapy treatment differ from other treatments for veteran wellbeing?

Focused Muscle Contraction Therapy, which involves aerobic and resistance training, is unique because it combines physical exercise with mindfulness practices, making it familiar and acceptable to veterans, especially those with PTSD. This approach not only targets physical health but also aims to improve mental health and quality of life by reducing PTSD symptoms and enhancing resilience. ^{11 12 13 14 15}

Research Team

Enrico Benedetti, MD

Principal Investigator

University of Illinois at Chicago

Eligibility Criteria

This trial is for U.S. Veterans over 18 who are patients at the Jesse Brown VA Medical Center, experiencing pain, fatigue, or reduced ability to perform activities. They must pass a health questionnaire or have doctor's clearance and be able to travel to the training center and comply with the program.

Inclusion Criteria

I am 18 years old or older.

I experience pain, fatigue, or struggle with daily activities.

I have passed a fitness assessment or have doctor's approval for physical activity.

Exclusion Criteria

I am unable to understand and give consent for treatment.

I cannot travel to the training center.

Unable to understand the study

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Testing

Initial baseline visit to measure fitness, strength, and health risk factors

1 day

1 visit (in-person)

Exercise Training Phase 1

Participants engage in exercise training twice a week for the first 6 months

6 months

52 visits (in-person)

Exercise Training Phase 2

Participants engage in exercise training once a week from 6 to 12 months

6 months

26 visits (in-person)

Exercise Training Phase 3

Participants engage in exercise training twice a month from 12 to 18 months

6 months

12 visits (in-person)

Follow-up

Participants are monitored for changes in body composition, physical abilities, and mental health

18 months

4 visits (in-person)

Treatment Details

Interventions

• Exercise Intervention (Focused Muscle Contraction Therapy)

Trial Overview The study tests if the GH Method exercise program can improve body composition, physical abilities, and wellbeing in veterans dealing with issues like depression or PTSD. It requires four fitness testing visits and ninety exercise sessions at GH FITLab over 18 months.

Participant Groups

Group I: Investigate the effects of an exercise intervention on U.S. Veterans. Experimental Treatment 1 Intervention

A total of 25 U.S. Veterans (≥ 18 years of age), who suffer from pain, fatigue, low energy levels or are unable to physically do things they were once able to do, will be enrolled.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

Mark I. Rosenblatt

University of Illinois at Chicago

Chief Executive Officer

MD, PhD, MBA, MHA

Jon Radosta

University of Illinois at Chicago

Chief Medical Officer since 2023

MD

Findings from Research

An 8-week exercise-based rehabilitation program for cancer survivors was found to be safe and feasible, with 61% of eligible participants starting the program and high satisfaction reported among attendees.

Participants showed clinically significant improvements in physical function and quality of life, with an average increase of 73 meters in walking distance and an 8-unit increase in quality of life scores, indicating the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bridging the gap: a pre-post feasibility study of embedding exercise therapy into a co-located cancer unit. Dennett, AM., Zappa, B., Wong, R., et al.[2021]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

In a 1.5-year study involving 274 male veterans with cardiovascular disease risk factors, only one serious adverse event (atrial fibrillation) occurred, indicating that a progressive walking program can be safely recommended for high-risk individuals.

While minor musculoskeletal issues were common, over half of the reported adverse events were unrelated to the exercise program, highlighting the need for strategies to help individuals with chronic illnesses safely resume physical activity after any health setbacks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. Goodrich, DE., Larkin, AR., Lowery, JC., et al.[2022]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

A 12-week Tai Chi intervention was found to be feasible and acceptable for individuals with posttraumatic stress disorder, with 90.9% of participants believing it would benefit their health.

Participants showed significant improvements in emotional well-being, cognitive function, and physical capabilities, including reduced pain intensity and enhanced memory and walking endurance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tai Chi for Posttraumatic Stress Disorder and Chronic Musculoskeletal Pain: A Pilot Study. Tsai, PF., Kitch, S., Chang, JY., et al.[2018]

References

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

Evaluation of a supervised exercise program in a geriatric population. [2019]

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

The impact of supervised exercise on the psychological well-being and health status of older veterans. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

Bridging the gap: a pre-post feasibility study of embedding exercise therapy into a co-located cancer unit. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise training for African Americans with disabilities residing in difficult social environments. [2022]

5. Denmark pubmed.ncbi.nlm.nih.gov

Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Adverse events among high-risk participants in a home-based walking study: a descriptive study. [2022]

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

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]

9. New Zealand 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. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. [2021]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Veterans Group Exercise: A randomized pilot trial of an Integrative Exercise program for veterans with posttraumatic stress. [2022]

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

Trauma-afflicted refugees' experiences of participating in physical activity and exercise treatment: a qualitative study based on focus group discussions. [2020]

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

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. [2020]

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

Tai Chi for Posttraumatic Stress Disorder and Chronic Musculoskeletal Pain: A Pilot Study. [2018]

15. Japan pubmed.ncbi.nlm.nih.gov

Clinical feasibility of cervical exercise to improve neck pain, body function, and psychosocial factors in patients with post-traumatic stress disorder: a randomized controlled trial. [2020]