Prebariatric Surgery Physical Activity Program

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Université de Sherbrooke
Sponsor:
Information provided by (Responsible Party):
Marie-France Langlois, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01452230
First received: October 7, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

Introduction: According to studies, a low physical capacity before surgery is linked with smaller weigh loss after surgery and increases risks of peri-surgical complications. Practice of regular physical activity in obese individuals improves their physical capacity. No specific recommendation on physical activity prescription is currently available for this reduced fitness population. This project aims to evaluate if a Pre-Surgical Physical Activity Training (PreSPAT) improves physical capacity, surgery effectiveness and decreases peri-surgical complications in morbidly obese individuals.

Methods: This pilot project will be divided in 2 phases:

Phase 1: Ten candidates for bariatric surgery will be included in this phase. In a pre-training focus group, subjects will be interviewed about their expectations and their availability for a PreSPAT. These results combined with those of the literature will be used to design the PreSPAT. To measure its effectiveness, anthropometric parameters, body composition, physical capacity, motivational stage, perceived benefits and barriers facing physical activity and quality of life will be evaluated before and after the PreSPAT. Subjects satisfaction with the physical activity intervention will be measured with a questionnaire at 6 weeks and at the end of the PreSPAT.

Phase 2: 50 candidates for bariatric surgery will be randomized in 2 groups:

Control group: receiving usual care from the integrated medical and surgical treatment obesity clinic of the Centre Hospitalier Universitaire de Sherbrooke, which includes individual counselling by an exercise physiologist every 6 weeks.

Intervention group: will attend for three months before surgery sessions of supervised physical activity as developed during phase 1 in addition to usual care of the integrated medical and surgical treatment obesity clinic.

Physical capacity, anthropometry, body composition, readiness to change, comorbidities, perceived benefits and barriers of physical activity, usual practice of physical activity, quality of life and patient satisfaction with physical activity intervention will be evaluated in the two groups before and after intervention and every 3 months after the surgery during one year. Each occurrence of peri-surgery complications, and the duration of surgery and hospitalization will be recorded.

Impacts: Feasibility and effectiveness of supervised physical activity training will be assessed before the beginning of the randomized controlled study. Phase 2 of the project may generate information that will improve the management of obese candidates for bariatric surgery in order to ensure optimal results for their health. This project will also allow a better understanding of criteria leading to successful surgery and the effects of exercise training in morbidly obese individuals.


Condition Intervention
Obesity
Behavioral: Supervised physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effectiveness and Efficacity of Presurgery Supervised Physical Activity Training on Health of Obese Individuals Waiting for Bariatric Surgery

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Change from baseline in physical fitness 2 weeks before surgery [ Time Frame: 2 weeks before surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in quality of life 2 weeks before surgery and every 3 months post surgery [ Time Frame: 2 weeks before surgery and every 3 months post surgery for 1 year ] [ Designated as safety issue: No ]
  • Number of participants with peri-operative complications [ Time Frame: every 3 months post surgery for 1 year ] [ Designated as safety issue: No ]
  • Change from baseline in comorbidities 2 weeks before surgery [ Time Frame: 2 weeks before surgery ] [ Designated as safety issue: No ]
  • Number of patients who did lifestyle modification [ Time Frame: 2 weeks before surgery and every 3 months post surgery for 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: October 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supervised physical activity Behavioral: Supervised physical activity
Supervised physical activity
No Intervention: Usual care

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • bariatric surgery candidate : morbid obesity (BMI>40)or severe obesity (BMI>35 with complications)
  • > 18 years old
  • follow usual care in the "Clinique médico-chirurgicale du traitement de l'obésité du Centre Hospitalier Universitaire de Sherbrooke (CHUS)" and ready to do presurgery evaluation(approximately 3 month before surgery)
  • no regular supervised physical activity
  • be willing to do on site supervised physical activity training
  • have read and given consent

Exclusion Criteria:

  • impossibility to come regularly to the CHUS to participate in physical activity training
  • medical contraindication for physical activity
  • major functional limitations: failure to realize the 6 minutes walking test
  • intellectual disability and / or neuropsychological disease
  • not being able to speak or understand french
  • being in Prochaska pre contemplation stage for regular physical activity practice
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452230

Contacts
Contact: Marie-France Langlois, MD 819-564-5241 marie-france.langlois@usherbrooke.ca
Contact: Christine Brown 819-346-1110 ext 12846 cbrown.chus@ssss.gouv.qc.ca

Locations
Canada, Quebec
Centre hospitalier universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Marie-France Langlois, MD    819-564-5241    marie-france.langlois@usherbrooke.ca   
Contact: Christine Brown    819-346-1110 ext 12846    cbrown.chus@ssss.gouv.qc.ca   
Principal Investigator: Marie-France Langlois, MD         
Sponsors and Collaborators
Université de Sherbrooke
Investigators
Principal Investigator: Marie-France Langlois, MD Université de Sherbrooke
  More Information

No publications provided

Responsible Party: Marie-France Langlois, Principal investigator, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01452230     History of Changes
Other Study ID Numbers: 11-112
Study First Received: October 7, 2011
Last Updated: March 3, 2014
Health Authority: Canada: Health Canada

Keywords provided by Université de Sherbrooke:
Bariatric Surgery Candidate
Severely obese
Bariatric surgery
Physical activity
Physical fitness
Comorbidities
Quality of life
Surgical complications

ClinicalTrials.gov processed this record on October 20, 2014