Prebariatric Surgery Physical Activity Program
Condition: Obesity
Study type: Interventional

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.
    

Detailed description: 
      Introduction: Bariatric surgery appears to be the most effective solution to improve health
      in morbidly obese individuals. However, this intervention is associated with risks than could
      be lower with pre-surgery intervention. 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.
      Hypotheses: In bariatric surgery patients, the PreSPAT should improve:

        -  subjects'health (physical capacity, weight, comorbidities, quality of life)

        -  subjects' motivation to do regular physical activity, their perceived benefits and
           barriers to do physical activity including pain, discomfort and dyspnea and their
           satisfaction with their physical activity management

        -  the duration of surgery and complications

        -  the postoperative management (duration, complications, re-operation,
           re-hospitalization). These two last items will probably require a larger population in a
           future project to complete data if they are conclusive.

      Materials and 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.
    

Intervention name(s): Supervised physical activity
Intervention type(s): Behavioral
Intervention description(s): Supervised physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Bariatric Surgery Candidate; Severely obese; Bariatric surgery; Physical activity; Physical fitness; Comorbidities; Quality of life; Surgical complications