Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans

NCT05094297 | Recruiting

• 1 other identifier: 2021-0832
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Acute Pain; Fatigue; Depression

Outcome Measures

Primary Outcomes (2)

• Rate at which exercise will change body composition

  With this hypothesis we will test whether muscle mass (DEXA scan) changes after 6 months, 12 months, 18 months of an exercise intervention. Baseline measurement will be performed before the intervention, at 6 months, 12 months, and at the end of the study (18 months) with muscle mass measured by DEXA.

  18 months

• Rate at which exercise will change body composition

  With this hypothesis we will test whether muscle strength (dynamometer) changes after 6 months, 12 months, 18 months of an exercise intervention. Baseline measurement will be performed before the intervention, at 6 months, 12 months, and at the end of the study (18 months) with strength measured by dynamometer.

  18 months

Secondary Outcomes (7)

• Rate at which subjects will see changes in their physical abilities

  18 months

• Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.

  18 months

• Rate at which subjects enrolled in the exercise intervention will have an overall changed in fatigue.

  18 Months

• Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.

  18 months

• Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in PTSD.

  18 months

Study Arms (1)

Investigate the effects of an exercise intervention on U.S. Veterans.

EXPERIMENTAL

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.

Behavioral: Investigate the effects of an exercise intervention on U.S. Veterans.

Interventions

Investigate the effects of an exercise intervention on U.S. Veterans. BEHAVIORAL

Enrolled subjects will be asked to complete 94 total visits (4 study testing visits and 90 exercise visits). They 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.

Investigate the effects of an exercise intervention on U.S. Veterans.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• U.S. Veterans
• Eligible subjects must be patients at the Jesse Brown VA Medical Center and suffer from pain, fatigue, low energy levels or are unable to physically do things they were once able to do.
• Subjects need to complete the PAR-Q with an acceptable score and/or must have written physician clearance.
• years of age and older

You may not qualify if:

• Unable to travel to the training center
• Unable to give consent
• Unable to understand the study
• Unable to comply with the training program

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Chronic Pain; Acute Pain; Fatigue; Depression

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Officials

• Enrico Benedetti, MD

  University of Illinois at Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilaria Santi

CONTACT

312-996-4706; isanti@uic.edu

Natalie Isho, MPH

CONTACT

312-996-4706; nisho@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Warren H. Cole Chair in Surgery, Professor and Head of Surgery, Medical Director, Abdominal Organ Transplant Program

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: October 26, 2021
• Study Start: October 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)