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Clinical Trials/NCT01100450
NCT01100450
Completed
N/A

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.

Beth Israel Deaconess Medical Center2 sites in 1 country6 target enrollmentSeptember 2009
ConditionsObesity

Overview

Phase
N/A
Intervention
Not specified
Conditions
Obesity
Sponsor
Beth Israel Deaconess Medical Center
Enrollment
6
Locations
2
Primary Endpoint
6-Minute Walk Test
Status
Completed
Last Updated
9 years ago

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
March 2011
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Miguel Alonso-Alonso, MD

Assistant Professor of Surgery

Beth Israel Deaconess Medical Center

Eligibility Criteria

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

Exclusion Criteria

  • Orthopedic limitations that would preclude exercise testing and training

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.

Secondary Outcomes

  • Muscle Fatigability Test(After training-Week 12)
  • 1-repetition maximum muscle strength test(After training - Week 12)

Study Sites (2)

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