Evaluating the Impact of Focused Muscle Contraction Therapy in U.S. Veterans
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Rate at which exercise will change body composition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Unable to travel to the training center
- •Unable to give consent
- •Unable to understand the study
- •Unable to comply with the training program
结局指标
主要结局
Rate at which exercise will change body composition
时间窗: 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.
次要结局
- 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 change in pain intensity.(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 decreased change in PTSD.(18 months)
- 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 decreased change in depression.(18 months)
研究者
Enrico Benedetti
Warren H. Cole Chair in Surgery, Professor and Head of Surgery, Medical Director, Abdominal Organ Transplant Program
University of Illinois at Chicago