Prebariatric Surgery Physical Activity Program

NCT01452230 | Completed

• 1 other identifier: 11-112
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity

Keywords

Bariatric Surgery Candidate; Severely obese; Bariatric surgery; Physical activity; Physical fitness; Comorbidities; Quality of life; Surgical complications

Outcome Measures

Primary Outcomes (1)

• Change from baseline in physical fitness 2 weeks before surgery

  2 weeks before surgery

Secondary Outcomes (4)

• Change from baseline in quality of life 2 weeks before surgery and every 3 months post surgery

  2 weeks before surgery and every 3 months post surgery for 1 year

• Number of participants with peri-operative complications

  every 3 months post surgery for 1 year

• Change from baseline in comorbidities 2 weeks before surgery

  2 weeks before surgery

• Number of patients who did lifestyle modification

  2 weeks before surgery and every 3 months post surgery for 1 year

Study Arms (2)

Supervised physical activity

EXPERIMENTAL

Behavioral: Supervised physical activity

Usual care

NO INTERVENTION

Interventions

Supervised physical activity BEHAVIORAL

Supervised physical activity

Supervised physical activity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Centre hospitalier universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (2)

• Baillot A, Vallee CA, Mampuya WM, Dionne IJ, Comeau E, Meziat-Burdin A, Langlois MF. Effects of a Pre-surgery Supervised Exercise Training 1 Year After Bariatric Surgery: a Randomized Controlled Study. Obes Surg. 2018 Apr;28(4):955-962. doi: 10.1007/s11695-017-2943-8.

  PMID: 28963710 DERIVED

• Baillot A, Mampuya WM, Dionne IJ, Comeau E, Meziat-Burdin A, Langlois MF. Impacts of Supervised Exercise Training in Addition to Interdisciplinary Lifestyle Management in Subjects Awaiting Bariatric Surgery: a Randomized Controlled Study. Obes Surg. 2016 Nov;26(11):2602-2610. doi: 10.1007/s11695-016-2153-9.

  PMID: 27038045 DERIVED

MeSH Terms

Conditions

Obesity; Motor Activity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Marie-France Langlois, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 7, 2011
• First Posted: October 14, 2011
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: September 1, 2018
• Last Updated: October 15, 2018

Record last verified: 2018-10

Locations

CA (1)