Follow-Up of Fitness in Overweight Patients Treated With Physical Activity (FUFPA)
Although there is increasing evidence that low physical fitness is a risk factor for many non-communicable diseases, the early identification of subjects at risk remains inadequate due to the absence of clear anamnestic and clinical criteria. Defining physical fitness. For the same reason, the monitoring of subjects following lifestyle interventions remains suboptimal.
The aim of this study is to develop a simple field tool to non-invasively assess global physical fitness in overweight patients participating to a physical activity program.
Male and female overweight subjects referred to a physical activity intervention by their primary care physician will be included. Within this program, they will take part to 2 weekly supervised activity sessions during which participants will be instructed by a specialist in adapted physical activity, and 2-3 weekly session of unsupervised physical activity which will be performed according to detailed instructions regarding intensity and duration. In addition, participants will take part to teaching sessions in group of 4-6 patients, addressing the effects of physical activity on metabolism, contra-indications to physical activity, self-monitoring of exercise, and prevention of injuries Their physical fitness will be assessed at inclusion (ie before starting the exercise program) and at the end of the 3-month program. This will be done by calculating a Global Fitness Score (GFS) based on performances attained and cardiovascular responses observed during physical exercises (3 min step test with measurement of heart rate and blood pressure, number of time subject can stand from a chair within 1 min., handgrip strength measure, "reach-test" to assess osteo-articular mobility of back and hips, balance test). Results obtained from this GFS will be compared to maximal power output calculated from a submaximal spirometry at 25, 50, 75 and 100 W M.
調査の概要
詳細な説明
Sedentarity is a risk factor for overweight, insulin resistance and diabetes mellitus. Several randomized clinical trials have shown that lifestyle interventions including exercise are efficient in improving metabolic homeostasis in overweight and obese patients. This may be related sedentarity being associated with low physical fitness, and to training enhancing it through multiple systems effects (cardiovascular and respiratory systems, central nervous system, osteo-articular system).
Although there is increasing evidence that low physical fitness is a risk factor for many non-communicable diseases, the early identification of subjects at risk remains inadequate due to the absence of clear anamnestic and clinical criteria. Defining physical fitness. For the same reason, the monitoring of subjects following lifestyle interventions remains suboptimal.
The aim of this study is to develop a simple field tool to non-invasively assess global physical fitness in overweight patients participating to a physical activity program.
Eigtheen male and female subjects, aged 18-50 years, BMI >27 kg/m2 referred to a physical activity intervention by their primary care physician, will be included. Their physical fitness will be assessed at inclusion (ie before starting the exercise program) and at the end of the 3-month program.This will be done by calculating a Global Fitness Score (GFS) based on performances attained and cardiovascular responses observed during 5 physical exercises (3 min step test with measurement of heart rate and blood pressure, number of time subject can stand from a chair within 1 min., handgrip strength measure, "reach-test" to assess osteo-articular mobility of back and hips, balance test). Results obtained from this GFS will be compared to maximal power output calculated from a submaximal spirometry at 25, 50, 75 and 100 W Primary outcome are: GFS (composite of a score of physical endurance, two scores of muscle strength, one score of balance, and one score of osteo-articular mobility) before and after 3 months of intervention.
Secondary outcomes are: physical activity questionnaire, maximal power output; maximal oxygen consumption; fat oxidation; fasting metabolic profile before and after 3 months of intervention.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Fribourg
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Estavayer le lac、Fribourg、スイス、1470
- 募集
- Hôpital Intercantonal de la Broye
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コンタクト：
- Virgile Lecoultre, PhD
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-
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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- BMI >27 kg/m2
Exclusion Criteria:
- cardio-respiratory diseases
- severe osteo-articular diseases
- any condition associated with contra-indication to exercise.
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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overweight subjects
Overweight male and females referred to a physical activity program by their primary care physician Intervention is being included in a 3-month physical activity training program
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subjects will enter a 3-month supervised physical activity program during which they will take part to supervised and unsupervised physical activity sessions.
Type of physical activity will be selected among a number of available activities (aquagym, aerobics, resistance training, outdoors activities) based on individual needs and preferences); it will consist in 2 weekly supervised activity sessions during which participants will be instructed by a specialist in adapted physical activity, and 2-3 weekly session of unsupervised physical activity which will be performed according to detailed instructions regarding intensity and duration.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Global Fitness Score before and after 3 months physical training
時間枠：After 3 month physical training
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Global fitness score ranges between 0 (very low fitness) and 30 (optimal fitness).
It is calculated as the sum of scores obtained with 5 simple field tests (Chester step test, score 0-10; handgrip, score 0-5; sit-and stand test, score 0-5; Sit and reach test, score 0-5; Flamingo test, score 0-5)
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After 3 month physical training
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協力者と研究者
スポンサー
捜査官
- スタディチェア：Charly Bulliard, MD、Hopital Intercantonal de la Broye, Estavayer le-lac, Switzerland
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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 (実際)
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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