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NCT Number: NCT01100450

Progressive Resistance Training in Patients With Class III Obesity

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive resistance training

Behavioral

12-week progressive resistance training (PRT) exercise program

Primary outcomes

  1. 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.

  2. 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

  1. Muscle Fatigability Test

    Time frame: Before training-Week 1

    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).

  2. 1-repetition maximum muscle strength test

    Time frame: Before training-Week 1

    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).

  3. Muscle Fatigability Test

    Time frame: After training-Week 12

    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).

  4. 1-repetition maximum muscle strength test

    Time frame: After training - Week 12

    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).

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 9, 2010
Registry last updated
Mar 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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