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CompletedNCT01100450Updated Mar 24, 2017

Progressive Resistance Training in Patients With Class III Obesity

An interventional study of Progressive Resistance Training in Obesity, sponsored by Beth Israel Deaconess Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-03-24.

Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
6
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity

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Keywords

  • bariatric surgery
  • class III obesity
  • resistance training
  • strength
  • fitness
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 6 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Orthopedic limitations that would preclude exercise testing and training
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Study arms

  • Experimental
    Resistance Training

    Behavioral: Progressive Resistance Training

Interventions

  • BehavioralProgressive Resistance Training

    12-week progressive resistance training (PRT) exercise program

06

What researchers measure

Primary outcomes

  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.

    Time frame: Before training - Week 1

  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.

    Time frame: After training - Week 12

Secondary outcomes

  1. Muscle Fatigability Test

    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).

    Time frame: Before training-Week 1

  2. 1-repetition maximum muscle strength test

    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).

    Time frame: Before training-Week 1

  3. Muscle Fatigability Test

    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).

    Time frame: After training-Week 12

  4. 1-repetition maximum muscle strength test

    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).

    Time frame: After training - Week 12

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Study locations

2 sites
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
  • Boston Medical Center
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01100450
Lead sponsor
Beth Israel Deaconess Medical Center
Responsible party
Miguel Alonso-Alonso, MD (Assistant Professor of Surgery, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Apr 9, 2010
Start date
Sep 2009
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Mar 24, 2017

Study contacts

George L Blackburn, MD, PhD
principal investigator · Beth Israel Deaconess Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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