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Prebariatric Surgery Physical Activity Program

10 oktober 2018 uppdaterad av: Marie-France Langlois, Université de Sherbrooke

Effectiveness and Efficacity of Presurgery Supervised Physical Activity Training on Health of Obese Individuals Waiting for Bariatric Surgery

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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Faktisk)

42

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Quebec
      • Sherbrooke, Quebec, Kanada, J1H 5N4
        • Centre hospitalier universitaire de Sherbrooke

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Inget ingripande: Vanlig skötsel
Experimentell: Övervakad fysisk aktivitet
Supervised physical activity

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Change from baseline in physical fitness 2 weeks before surgery
Tidsram: 2 weeks before surgery
2 weeks before surgery

Sekundära resultatmått

Resultatmått
Tidsram
Change from baseline in quality of life 2 weeks before surgery and every 3 months post surgery
Tidsram: 2 weeks before surgery and every 3 months post surgery for 1 year
2 weeks before surgery and every 3 months post surgery for 1 year
Number of participants with peri-operative complications
Tidsram: every 3 months post surgery for 1 year
every 3 months post surgery for 1 year
Change from baseline in comorbidities 2 weeks before surgery
Tidsram: 2 weeks before surgery
2 weeks before surgery
Number of patients who did lifestyle modification
Tidsram: 2 weeks before surgery and every 3 months post surgery for 1 year
2 weeks before surgery and every 3 months post surgery for 1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Marie-France Langlois, MD, Université de Sherbrooke

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2011

Primärt slutförande (Faktisk)

1 juni 2015

Avslutad studie (Faktisk)

1 september 2018

Studieregistreringsdatum

Först inskickad

7 oktober 2011

Först inskickad som uppfyllde QC-kriterierna

11 oktober 2011

Första postat (Uppskatta)

14 oktober 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

15 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 oktober 2018

Senast verifierad

1 oktober 2018

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Fetma

Kliniska prövningar på Supervised physical activity

3
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