Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans
Primary Purpose
Chronic Pain, Acute Pain, Fatigue
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Investigate the effects of an exercise intervention on U.S. Veterans.
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Pain
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unable to travel to the training center
- Unable to give consent
- Unable to understand the study
- Unable to comply with the training program
Sites / Locations
- University of Illinois at ChicagoRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Investigate the effects of an exercise intervention on U.S. Veterans.
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05094297
First Posted
September 20, 2021
Last Updated
April 5, 2023
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT05094297
Brief Title
Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans
Official Title
Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Acute Pain, Fatigue, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Investigate the effects of an exercise intervention on U.S. Veterans.
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Investigate the effects of an exercise intervention on U.S. Veterans.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate at which exercise will change body composition
Description
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.
Time Frame
18 months
Title
Rate at which exercise will change body composition
Description
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.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Rate at which subjects will see changes in their physical abilities
Description
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.
Time Frame
18 months
Title
Rate at which subjects enrolled in the exercise intervention will have an overall changed sense of well-being.
Description
Participants will be asked about their overall general health using the PROMIS.
Time Frame
18 months
Title
Rate at which subjects enrolled in the exercise intervention will have an overall changed in fatigue.
Description
Participants will be asked about their mental health using the Fatigue Severity Index.
Time Frame
18 Months
Title
Rate at which subjects enrolled in the exercise intervention will have an overall changed in their quality of life.
Description
Participants will be asked about their mental health using SF 36.
Time Frame
18 months
Title
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in PTSD.
Description
Participants will be asked about their mental health using the PSS-SR5.
Time Frame
18 months
Title
Rate at which subjects enrolled in the exercise intervention will have an overall decreased change in depression.
Description
Participants will be asked about their mental health using the BDI.
Time Frame
18 months
Title
Rate at which subjects enrolled in the exercise intervention will have an overall change in pain intensity.
Description
Participants will be asked about their overall pain intensity using the Numeric Rating Scale for Pain.
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Unable to travel to the training center
Unable to give consent
Unable to understand the study
Unable to comply with the training program
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilaria Santi
Phone
312-996-4706
Email
isanti@uic.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Isho, MPH
Phone
312-996-4706
Email
nisho@uic.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enrico Benedetti, MD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Isho, MPH
Phone
312-996-4706
Email
nisho@uic.edu
First Name & Middle Initial & Last Name & Degree
Enrico Benedetti, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans
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