Progressive Resistance Training in Patients With Class III Obesity
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.
1 other identifier
interventional
6
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 16, 2009
CompletedFirst Posted
Study publicly available on registry
April 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedMarch 24, 2017
March 1, 2017
1.5 years
October 16, 2009
March 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
6-Minute Walk Test
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.
Before training - Week 1
6-Minute Walk Test
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.
After training - Week 12
Secondary Outcomes (4)
Muscle Fatigability Test
Before training-Week 1
1-repetition maximum muscle strength test
Before training-Week 1
Muscle Fatigability Test
After training-Week 12
1-repetition maximum muscle strength test
After training - Week 12
Study Arms (1)
Resistance Training
EXPERIMENTALInterventions
12-week progressive resistance training (PRT) exercise program
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Orthopedic limitations that would preclude exercise testing and training
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Boston Medical Center
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George L Blackburn, MD, PhD
Beth Israel Deaconess Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Surgery
Study Record Dates
First Submitted
October 16, 2009
First Posted
April 9, 2010
Study Start
September 1, 2009
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
March 24, 2017
Record last verified: 2017-03