Prebariatric Surgery Physical Activity Program
|ClinicalTrials.gov Identifier: NCT01452230|
Recruitment Status : Active, not recruiting
First Posted : October 14, 2011
Last Update Posted : October 25, 2017
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 or disease||Intervention/treatment||Phase|
|Obesity||Behavioral: Supervised physical activity||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (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|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||June 2018|
|Experimental: Supervised physical activity||
Behavioral: Supervised physical activity
Supervised physical activity
|No Intervention: Usual care|
- Change from baseline in physical fitness 2 weeks before surgery [ Time Frame: 2 weeks before surgery ]
- 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 ]
- Number of participants with peri-operative complications [ Time Frame: every 3 months post surgery for 1 year ]
- Change from baseline in comorbidities 2 weeks before surgery [ Time Frame: 2 weeks before surgery ]
- Number of patients who did lifestyle modification [ Time Frame: 2 weeks before surgery and every 3 months post surgery for 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01452230
|Centre hospitalier universitaire de Sherbrooke|
|Sherbrooke, Quebec, Canada, J1H 5N4|
|Principal Investigator:||Marie-France Langlois, MD||Université de Sherbrooke|