Clinical trial NCT01100450: Progressive Resistance Training in Patients With Class III Obesity
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: bariatric surgery
class III obesity
resistance training
strength
fitness
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-04-09
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility 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

Primary outcomes:
measure: 6-Minute Walk Test
timeFrame: Before training - Week 1
measure: 6-Minute Walk Test
timeFrame: After training - Week 12
Secondary outcomes:
measure: Muscle Fatigability Test
timeFrame: Before training-Week 1
measure: 1-repetition maximum muscle strength test
timeFrame: Before training-Week 1
measure: Muscle Fatigability Test
timeFrame: After training-Week 12
measure: 1-repetition maximum muscle strength test
timeFrame: After training - Week 12
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: George L Blackburn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: