Progressive Resistance Training in Patients With Class III Obesity

March 22, 2017 updated by: Miguel Alonso-Alonso, MD, Beth Israel Deaconess Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Resistance Training
Behavioral: Progressive Resistance Training
12-week progressive resistance training (PRT) exercise program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Before training - Week 1
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.
After training - Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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).
Before training-Week 1
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).
Before training-Week 1
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).
After training-Week 12
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).
After training - Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beth Israel Deaconess Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: George L Blackburn, MD, PhD, Beth Israel Deaconess Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 9, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2009P000083

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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