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Progressive Resistance Training in Patients With Class III Obesity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01100450
First received: October 16, 2009
Last updated: December 19, 2013
Last verified: December 2013

October 16, 2009
December 19, 2013
September 2009
March 2011   (final data collection date for primary outcome measure)
  • 6-Minute Walk Test [ Time Frame: Before training - Week 1 ] [ Designated as safety issue: No ]
    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: After training - Week 12 ] [ Designated as safety issue: No ]
    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.
Same as current
Complete list of historical versions of study NCT01100450 on ClinicalTrials.gov Archive Site
  • Muscle Fatigability Test [ Time Frame: Before training-Week 1 ] [ Designated as safety issue: No ]
    After appropriate warm-up, subjects performed as many repetitions as possible against a resistance set to 80% or 70% (leg and chest respectively) of their pre-intervention 1-repetition maximum resistance. Fatigability tests measures the ability to sustain a static muscle contraction or make repetitive submaximal dynamic contractions. The test was administered using the leg press and chest press machines (Nautilus Nitro).
  • 1-repetition maximum muscle strength test [ Time Frame: Before training-Week 1 ] [ Designated as safety issue: No ]
    The subject performs repeated single repetitions of leg press and chest press, separated by 60-second rest periods. Resistance is increased systematically at each repetition until the person's maximum voluntary muscle force cannot move the resistance through the full range of motion. The greatest resistance (measured in lbs.) a person can move through a full range of motion is recorded as the "one-repetition maximum." Tests were performed on leg and chest press machines (Nautilus Nitro).
  • Muscle Fatigability Test [ Time Frame: After training-Week 12 ] [ Designated as safety issue: No ]
    After appropriate warm-up, subjects performed as many repetitions as possible against a resistance set to 80% or 70% (leg and chest respectively) of their pre-intervention 1-repetition maximum resistance. Fatigability tests measures the ability to sustain a static muscle contraction or make repetitive submaximal dynamic contractions. The test was administered using the leg press and chest press machines (Nautilus Nitro).
  • 1-repetition maximum muscle strength test [ Time Frame: After training - Week 12 ] [ Designated as safety issue: No ]
    The subject performs repeated single repetitions of leg press and chest press, separated by 60-second rest periods. Resistance is increased systematically at each repetition until the person's maximum voluntary muscle force cannot move the resistance through the full range of motion. The greatest resistance (measured in lbs.) a person can move through a full range of motion is recorded as the "one-repetition maximum." Tests were performed on leg and chest press machines (Nautilus Nitro).
Same as current
Not Provided
Not Provided
 
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Obesity
Behavioral: Progressive Resistance Training
12-week progressive resistance training (PRT) exercise program
Experimental: Resistance Training
Intervention: Behavioral: Progressive Resistance Training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6
March 2011
March 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01100450
2009P-000083
Yes
Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
Not Provided
Principal Investigator: George L Blackburn, MD, PhD Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP