Progressive Resistance Training in Patients With Class III Obesity

NCT ID: NCT01100450

Last Updated: 2017-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Resistance Training

Group Type EXPERIMENTAL

Progressive Resistance Training

Intervention Type BEHAVIORAL

12-week progressive resistance training (PRT) exercise program

Interventions

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Progressive Resistance Training

12-week progressive resistance training (PRT) exercise program

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Miguel Alonso-Alonso, MD

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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George L Blackburn, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2009P000083

Identifier Type: -

Identifier Source: org_study_id

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