Focused Muscle Contraction Therapy for Veteran Wellbeing

Overseen By Ilaria Santi

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Illinois at Chicago

Disqualifiers: Travel limitations, Consent issues, Comprehension, Compliance

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

Compensation: Varies

Number of Visits: 95

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a specific exercise program, Focused Muscle Contraction Therapy, can improve fitness, strength, and overall well-being in U.S. Veterans. It targets those experiencing pain, fatigue, low energy, or difficulty engaging in activities they once enjoyed. Participants will attend 94 visits, which include regular exercise sessions and assessments of physical and mental health. Veterans who are patients at the Jesse Brown VA Medical Center and meet the criteria are encouraged to consider joining. As an unphased trial, this study offers Veterans the chance to contribute to research that could enhance their quality of life and well-being.

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 prior data suggests that this exercise program is safe for U.S. Veterans?

Research shows that exercise programs are generally safe for veterans. Studies have found that regular exercise can reduce pain, fatigue, and mood problems without causing serious harm. In one study, veterans who exercised for several months slept better and felt healthier, with no major negative effects. Another review found that exercise reduced PTSD symptoms and lowered suicidal thoughts in veterans, again without significant negative effects. This suggests that exercise programs are well-tolerated and could improve overall health in veterans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for pain and fatigue, which often involve medication or physical therapy, this exercise intervention focuses on the precise technique of focused muscle contractions. Researchers are excited because this method aims to enhance physical capabilities and energy levels without the side effects associated with medications. Additionally, this approach is tailored specifically for U.S. Veterans, addressing their unique physical and mental needs, which may lead to improved overall wellbeing and quality of life.

What evidence suggests that this exercise intervention is effective for improving wellbeing in U.S. Veterans?

Studies have shown that exercise can greatly enhance both physical and mental health in veterans. For example, one study found that supervised exercise improved endurance and physical abilities in older veterans with PTSD. Another study showed that over 90% of participants felt better physically and mentally after completing an exercise program. Exercise has also been linked to reduced pain, less fatigue, and improved moods. Overall, these findings suggest that exercise can effectively improve wellbeing in veterans, particularly for issues like depression and PTSD. Participants in this trial will explore the effects of an exercise intervention specifically designed for U.S. Veterans. ^{1 3 6 7 8}

Who Is on the Research Team?

Enrico Benedetti, MD

Principal Investigator

University of Illinois at Chicago

Are You a Good Fit for This Trial?

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 experience pain, fatigue, or struggle with daily activities.

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

Patients at the Jesse Brown VA Medical Center

Exclusion Criteria

I am unable to understand and give consent for treatment.

I cannot travel to the training center.

Unable to understand the study

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Exercise Intervention

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

Participation in physical activity (PA) and exercise significantly helps trauma-afflicted refugees build resilience, improving both their physical and mental health, as reported by 33 participants in focus group discussions.

The group-based treatment settings not only provided relief from daily stressors but also fostered social connections, enhancing self-awareness and self-confidence, which positively impacted participants' family life and social relationships.

NCBI (Pubmed)

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. Nilsson, H., Saboonchi, F., Gustavsson, C., et al.[2020]

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]

The Integrative Exercise (IE) program, which combines aerobic and resistance exercises with mindfulness practices, significantly reduced PTSD symptom severity in veterans compared to a waitlist control group, with a large effect size (d = -0.90).

Veterans participating in the IE program also reported improvements in psychological quality of life (d = 0.53) and found the program to be highly feasible and acceptable, suggesting it could be a valuable alternative treatment for those hesitant to pursue traditional mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veterans Group Exercise: A randomized pilot trial of an Integrative Exercise program for veterans with posttraumatic stress. Goldstein, LA., Mehling, WE., Metzler, TJ., et al.[2022]

Cervical exercise significantly reduced neck pain and disability in patients with post-traumatic stress disorder, with notable improvements in pain scores and disability indices after 6 weeks of exercise compared to conventional therapy.

The exercise program also positively impacted psychological factors, leading to a significant decrease in depression symptoms, although it did not significantly affect anxiety levels.

NCBI (Pubmed)

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. Park, SD., Kim, SY.[2020]

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]

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]

A study involving 69 elderly veterans, many with chronic illnesses, showed that a structured exercise program significantly improved cardiovascular fitness over 4 months, with notable increases in metabolic equivalents and treadmill performance.

The exercise intervention, consisting of 90 minutes of activity three times a week, was well-attended (65% average) and demonstrated that even those with chronic conditions can benefit from regular physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a supervised exercise program in a geriatric population. Morey, MC., Cowper, PA., Feussner, JR., et al.[2019]

In a study of 43 elderly veterans participating in a supervised exercise program, significant improvements in well-being were observed, with the Psychological General Well-Being Index score increasing from 83.0 to 89.4 after one year (p = .01).

The exercise intervention, consisting of 90 minutes of activity three times a week, also led to significant enhancements in cardiovascular fitness, as indicated by improved treadmill performance (p = .004), highlighting the physiological benefits of regular exercise in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of supervised exercise on the psychological well-being and health status of older veterans. Cowper, PA., Morey, MC., Bearon, LB., et al.[2017]

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]

A 12-week structured exercise program significantly improved cardiovascular fitness and strength in a group of 44 predominantly African-American adults with various health conditions, with 87% attendance at sessions.

While the exercise program led to improvements in peak VO2 and strength, it did not significantly affect body weight or waist-to-hip ratio, suggesting that while fitness levels increased, body composition changes may require longer or different interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise training for African Americans with disabilities residing in difficult social environments. Rimmer, JH., Nicola, T., Riley, B., et al.[2022]

Exercise is an effective treatment option for a wide range of diseases, including psychiatric, neurological, metabolic, cardiovascular, pulmonary, musculoskeletal disorders, and cancer, as outlined in this comprehensive review.

The review discusses the mechanisms of action of exercise therapy and provides evidence-based recommendations for the optimal type and dosage of exercise for each specific disease, emphasizing its role as a form of medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise as medicine - evidence for prescribing exercise as therapy in 26 different chronic diseases. Pedersen, BK., Saltin, B.[2022]

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]

Resistance training (RT) significantly reduces all-cause mortality and the incidence of cardiovascular disease while improving physical functioning in adults, based on an analysis of 11 systematic reviews involving over 382,000 participants.

Although adverse events were not consistently reported, serious adverse events related to RT were uncommon, suggesting that the benefits of resistance training outweigh the potential harms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resistance training and health in adults: an overview of systematic reviews. El-Kotob, R., Ponzano, M., Chaput, JP., et al.[2021]

The Warrior Wellness pilot study aims to assess the feasibility and effectiveness of a 12-week exercise program for older veterans (aged 60 and above) with PTSD, focusing on improving PTSD symptoms and cardiovascular endurance.

This study will provide insights into how regular exercise can impact the health of older veterans with PTSD, potentially leading to better treatment options and improved quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Warrior Wellness Study: A Randomized Controlled Exercise Trial for Older Veterans with PTSD. Hall, KS., Morey, MC., Beckham, JC., et al.[2020]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7973256/

Warrior Wellness: A Randomized Controlled Pilot Trial of ... Participation in supervised exercise improved aerobic endurance, physical performance, and health-related clinical factors in older veterans with PTSD.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10214409/

Safety and efficacy of short-term structured resistance ... Outcomes, assessed at baseline, 6, 11 and 17 weeks and 6- and 12-months post-intervention, were: pain, fatigue, mood, sleep quality, perception of improvement, ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1440244021001584

Stepped-down intervention programs to promote self ... This study reviewed the effectiveness of stepped-down interventions to promote self-managed physical activity for health in military service veterans.

4. mdpi.com mdpi.com/1660-4601/16/14/2630

Insights Following Implementation of an Exercise ... Over 90% of participants reported improvements in physical and mental health at the end of the program. Respondents also indicated that the exercise ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04103593

NCT04103593 | Functional Interval Training for Veterans ... The investigators found a 42% reduction in VO2peak in older HIV+ adults that significantly improved with high-intensity aerobic (AEX) and resistance training ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10422854/

Feasibility of Mindfulness-Based Intervention for Veterans ... This study aimed to (1) evaluate the feasibility of the Mindfulness-Based Chronic Pain Management (MBCPMTM) program on reducing pain perception and enhancing ...

7. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2024.1483077/full

A narrative review of exercise intervention mechanisms for ... Exercise was found to reduce PTSD symptoms in veterans at both psychological and physiological levels, which in turn inhibits their suicidal tendencies.

8. researchgate.net researchgate.net/publication/353172271_Safety_and_efficacy_of_short-term_structured_resistance_exercise_in_Gulf_War_Veterans_with_chronic_unexplained_muscle_pain_A_randomized_control_trial

Safety and efficacy of short-term structured resistance ... Outcomes, assessed at baseline, 6, 11 and 17 weeks and 6- and 12-months post-intervention, were: pain, fatigue, mood, sleep quality, perception ...