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Progressive Resistance Training in Patients With Class III Obesity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Beth Israel Deaconess Medical Center.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT01100450
First received: October 16, 2009
Last updated: May 26, 2010
Last verified: April 2010
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Behavioral: Progressive Resistance Training

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 8
Study Start Date: September 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Resistance Training Behavioral: Progressive Resistance Training
12-week progressive resistance training (PRT) exercise program

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • Has reliable transportation to the intervention location

Exclusion Criteria:

  • Orthopedic limitations that would preclude exercise testing and training
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100450

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Boston Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: George L Blackburn, MD, PhD Beth Israel Deaconess Medical Center
  More Information

No publications provided

Responsible Party: George L. Blackburn/Director of the Center for the Study of Nutrition Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01100450     History of Changes
Other Study ID Numbers: 2009P-000083
Study First Received: October 16, 2009
Last Updated: May 26, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
bariatric surgery
class III obesity
resistance training
strength
fitness

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013