Pilot Study to Determine Feasibility, Acceptance, and Efficacy of a 12-week Progressive Resistance Training Exercise Protocol in Patients With Class III Obesity Preparing for Bariatric Surgery.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- 6-Minute Walk Test
Study Overview
Brief Summary
To test the strength and physical performance outcomes of a 12-week progressive resistance training (PRT) exercise program in a small cohort of patients with Class III obesity who are preparing for bariatric weight loss surgery at Beth Israel Deaconess. The study will also test patient compliance to the 12 week PRT program. Whereas PRT exercise is currently recommended as a part of preoperative clinical care for bariatric surgery patients, little research has been done to measure the acceptance and effectiveness of a standardized PRT exercise protocol for improving health and perioperative care. Preliminary data from this study could be used to justify larger studies and further investigation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women 18-65 years old
- •A BMI of ≥40 kg/m2
- •Considering Weight Loss Surgery at BIDMC
- •Participating in multidisciplinary preoperative program:
- •been determined by a mental health professional (i.e., psychologist or social worker) to be well-informed, motivated, and not symptomatic for psychopathology that would put the person at risk for injury or failure with WLS
- •expressed strong desire for significant weight loss
- •experienced documented failure of long-term weight loss using nonsurgical methods
- •been informed of and accepts risks of surgery
- •Cleared by their primary care physician to be in stable health and capable of moderate level exercise
- •Willing to comply with expected attendance and participation at all intervention sessions and testing appointments
- •Has reliable transportation to the intervention location
Exclusion Criteria
- •Orthopedic limitations that would preclude exercise testing and training
Arms & Interventions
Resistance Training
Intervention: Progressive Resistance Training (Behavioral)
Outcomes
Primary Outcomes
6-Minute Walk Test
Time Frame: After training - Week 12
Subjects are instructed to walk from one end to the other of a 30- meter hallway at their own pace, while attempting to cover as much ground as possible in the allotted 6 minutes. Subjects are allowed to stop and rest during the test, but were instructed to resume walking as soon as they felt able to do so. Total distance walked was recorded at the end of the test.
6-Minute Walk Test
Time Frame: Before training - Week 1
Subjects are instructed to walk from one end to the other of a 30- meter hallway at their own pace, while attempting to cover as much ground as possible in the allotted 6 minutes. Subjects are allowed to stop and rest during the test, but were instructed to resume walking as soon as they felt able to do so. Total distance walked was recorded at the end of the test.
Secondary Outcomes
- Muscle Fatigability Test(After training-Week 12)
- 1-repetition maximum muscle strength test(After training - Week 12)
- Muscle Fatigability Test(Before training-Week 1)
- 1-repetition maximum muscle strength test(Before training-Week 1)
Investigators
Miguel Alonso-Alonso, MD
Assistant Professor of Surgery
Beth Israel Deaconess Medical Center