Chronic PainNCT05094297
Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans
A study testing Investigate the effects of an exercise intervention on U.S. Veterans. in people with Chronic Pain and Acute Pain, run by University of Illinois Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Acute Pain, Fatigue
- What is being tested?
- Investigate the effects of an exercise intervention on U.S. Veterans.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 18 years of age and older
Who cannot join
- Unable to travel to the training center
- Unable to give consent
- Unable to understand the study
- Unable to comply with the training program
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Chicago
Chicago, Illinois, 60612
Natalie Isho, MPH, 312-996-4706, nisho@uic.edu
Enrico Benedetti, MD
About this study
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.
Read the detailed description
The study will consist of 94 visits (4 study testing visits and 90 exercise visits). Subjects will come to UIC for study testing visits at baseline (prior to starting the exercise program), at 6 months, 12 months, and 18 months (after ending the exercise program). Each of those visits will take about 2-3 hours. After the initial baseline visit, subjects will come twice weekly, for roughly 1 hour each session, for 6 months (52 visits). From 6-12 months, subjects will come once a week, for roughly 1 hour each session (26 visits). From 12-18 months, subjects will come twice a month, for roughly 1 hour sessions (12 visits).
Methods:
Study Testing Visits
If subjects agree to be in the study, subjects will be asked to do the following procedures at baseline, 6 months, 12 months, and 18 months:
- Subjects will be asked to confirm their employment status each visit.
- Height and weight will be measured and body mass index (BMI) will be calculated.
Additionally, the investigators will measure the body fat composition and lean body mass using a DEXA scan.
- The investigators will ask subject's their age, race, number of injuries, number of fractures, surgical history, medical history, areas of pain, list of pain medications and allergies.
- Blood pressure will be measured for general health markers.
- Exercise limit will be measured with a timed 8 foot walk down the hallway (if applicable), a timed sit to stand test (sitting and standing 5 times in a row-if applicable), maximum sit to stands, and a balance test (standing in 3 different positions for 10 seconds each). These three tests combine to form a score called a short performance battery score.
- Strength and frailty will be measured using a grip dynamometer (squeezing a hand held device as hard as possible in their dominant hand three times.
- To evaluate general health, mental health (e.g. depression, post-traumatic stress disorder, etc.) and pain intensity, quality of life, measure of pain and disability, and fatigue, questionnaires will be administered.
- Subjects will be asked to disclose the number of hospital visits they have had in the last 18 months.
- Total weight lifted during training session will also be recorded.
Exercise Training Visits
After the initial baseline visit, subjects will begin their exercise training intervention which involves:
- Two days a week of exercise trainings for the first 6 months, and one day a week, from 6-12 months. From 12-18 months, subjects will then complete two days a month of exercise training. Each visit will last roughly one hour and will incorporate approximately 5-10 minute light warm-up plus stretching and then the exercises.
- At least twice weekly, GH Fitness staff will follow-up with subjects via text message, email or a phone call to evaluate subjects physical progress and overall health and energy.
- On Weeks 6, 13, 18, 25, 41, and 52 subjects will focus on cardio and endurance exercises. These exercises may include running in place, or using a recumbent (stationary) bike. All other weeks consist of basic strength training/resistance workouts.
List of All Possible Strength/Resistance Exercises
Exercise Chest: Smith Bench Press/Incline Glutes: Abductor Biceps: Cable Easy Curl/Free Bar Quads: Leg Extension Calves: Calf Machine Biceps: Preacher Quads: Leg Press Abs: Decline Back: Pull Down Behind Hamstring: Curl Machine Shoulders: Dumbbell Press / Smith Press Back: Low Roll Hamstring: Good Morning with Dumbbell/ 1 Leg Hamstring Curl Shoulders: Side Rise with Dumbbells Triceps: Push Down / Kick Back Abs: Sit Ups Triceps: Close Grip
- Conditions
- Chronic Pain, Acute Pain, Fatigue, Depression
- Being tested
- Investigate the effects of an exercise intervention on U.S. Veterans.
- Medical subject headings
- Chronic Pain, Acute Pain, Fatigue, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigate the effects of an exercise intervention on U.S. Veterans.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Investigate the effects of an exercise intervention on U.S. Veterans. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 18 months
Secondary outcomes (7)
Rate at which subjects will see changes in their physical abilities
We expect participants will see improvements in their physical abilities after 18 months in the exercise training sessions. This will be assessed by comparing baseline, 6 months, 12 months, and 18 months using a Short Physical Performance Battery test. This test requires the assessment of walking speed (time to walk 3 meters), a balance test (standing in 3 different positions for 10 seconds each-tandem, semi tandem, and side by side), and the time it takes to sit and stand 5 times in a chair (see above). Scoring is based on a scale of 0-12, lower numbers representing worse performance.
Measured: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.
Participants will be asked about their overall general health using the PROMIS.
Measured: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall changed in fatigue.
Participants will be asked about their mental health using the Fatigue Severity Index.
Measured: 18 Months
Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.
Participants will be asked about their mental health using SF 36.
Measured: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in PTSD.
Participants will be asked about their mental health using the PSS-SR5.
Measured: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.
Participants will be asked about their mental health using the BDI.
Measured: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.
Participants will be asked about their overall pain intensity using the Numeric Rating Scale for Pain.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start1 Oct 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enrico Benedetti, University of Illinois Chicago
- Investigators
- Enrico Benedetti, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094297
- Sponsor's protocol ID
- 2021-0832
- Status last verified
- Sep 2025
- First submitted
- 20 Sep 2021
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans
- ClinicalTrials.gov ID
- NCT05094297
- Acronym / sponsor ID
- 2021-0832
- Conditions
- Chronic Pain, Acute Pain, Fatigue, Depression
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will consist of 94 visits (4 study testing visits and 90 exercise visits). Subjects will come to UIC for study testing visits at baseline (prior to starting the exercise program), at 6 months, 12 months, and 18 months (after ending the exercise program). Each of those visits will take about 2-3 hours. After the initial baseline visit, subjects will come twice weekly, for roughly 1 hour each session, for 6 months (52 visits). From 6-12 months, subjects will come once a week, for roughly 1 hour each session (26 visits). From 12-18 months, subjects will come twice a month, for roughly 1 hour sessions (12 visits).
Methods:
Study Testing Visits
If subjects agree to be in the study, subjects will be asked to do the following procedures at baseline, 6 months, 12 months, and 18 months:
- Subjects will be asked to confirm their employment status each visit.
- Height and weight will be measured and body mass index (BMI) will be calculated.
Additionally, the investigators will measure the body fat composition and lean body mass using a DEXA scan.
- The investigators will ask subject's their age, race, number of injuries, number of fractures, surgical history, medical history, areas of pain, list of pain medications and allergies.
- Blood pressure will be measured for general health markers.
- Exercise limit will be measured with a timed 8 foot walk down the hallway (if applicable), a timed sit to stand test (sitting and standing 5 times in a row-if applicable), maximum sit to stands, and a balance test (standing in 3 different positions for 10 seconds each). These three tests combine to form a score called a short performance battery score.
- Strength and frailty will be measured using a grip dynamometer (squeezing a hand held device as hard as possible in their dominant hand three times.
- To evaluate general health, mental health (e.g. depression, post-traumatic stress disorder, etc.) and pain intensity, quality of life, measure of pain and disability, and fatigue, questionnaires will be administered.
- Subjects will be asked to disclose the number of hospital visits they have had in the last 18 months.
- Total weight lifted during training session will also be recorded.
Exercise Training Visits
After the initial baseline visit, subjects will begin their exercise training intervention which involves:
- Two days a week of exercise trainings for the first 6 months, and one day a week, from 6-12 months. From 12-18 months, subjects will then complete two days a month of exercise training. Each visit will last roughly one hour and will incorporate approximately 5-10 minute light warm-up plus stretching and then the exercises.
- At least twice weekly, GH Fitness staff will follow-up with subjects via text message, email or a phone call to evaluate subjects physical progress and overall health and energy.
- On Weeks 6, 13, 18, 25, 41, and 52 subjects will focus on cardio and endurance exercises. These exercises may include running in place, or using a recumbent (stationary) bike. All other weeks consist of basic strength training/resistance workouts.
List of All Possible Strength/Resistance Exercises
Exercise Chest: Smith Bench Press/Incline Glutes: Abductor Biceps: Cable Easy Curl/Free Bar Quads: Leg Extension Calves: Calf Machine Biceps: Preacher Quads: Leg Press Abs: Decline Back: Pull Down Behind Hamstring: Curl Machine Shoulders: Dumbbell Press / Smith Press Back: Low Roll Hamstring: Good Morning with Dumbbell/ 1 Leg Hamstring Curl Shoulders: Side Rise with Dumbbells Triceps: Push Down / Kick Back Abs: Sit Ups Triceps: Close Grip
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Investigate the effects of an exercise intervention on U.S. Veterans. | Experimental | Behavioral: Investigate the effects of an exercise intervention on U.S. Veterans.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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 18 years of age and older
Key exclusion criteria (4 listed)
- Unable to travel to the training center
- Unable to give consent
- Unable to understand the study
- Unable to comply with the training program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigate the effects of an exercise intervention on U.S. Veterans.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. | Behavioural | Investigate the effects of an exercise intervention on U.S. Veterans. |
Primary outcome
Rate at which exercise will change body composition
Time frame: 18 months
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.
Rate at which exercise will change body composition
Time frame: 18 months
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.
7 secondary outcomes
Rate at which subjects will see changes in their physical abilities
Time frame: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.
Time frame: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall changed in fatigue.
Time frame: 18 Months
Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.
Time frame: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in PTSD.
Time frame: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.
Time frame: 18 months
Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Enrico Benedetti, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigate the effects of an exercise intervention on U.S. Veterans. in people with Chronic Pain and Acute Pain, run by University of Illinois Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Santi (312-996-4706, isanti@uic.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate at which exercise will change body composition (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.