Prebariatric Surgery Physical Activity Program
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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Quebec
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Sherbrooke、Quebec、カナダ、J1H 5N4
- Centre hospitalier universitaire de Sherbrooke
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
介入なし:普段のお手入れ
|
|
実験的:監視付きの身体活動
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Supervised physical activity
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
---|---|
Change from baseline in physical fitness 2 weeks before surgery
時間枠:2 weeks before surgery
|
2 weeks before surgery
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Change from baseline in quality of life 2 weeks before surgery and every 3 months post surgery
時間枠: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
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Number of participants with peri-operative complications
時間枠:every 3 months post surgery for 1 year
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every 3 months post surgery for 1 year
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Change from baseline in comorbidities 2 weeks before surgery
時間枠:2 weeks before surgery
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2 weeks before surgery
|
Number of patients who did lifestyle modification
時間枠:2 weeks before surgery and every 3 months post surgery for 1 year
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2 weeks before surgery and every 3 months post surgery for 1 year
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Marie-France Langlois, MD、Université de Sherbrooke
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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