Feasibility and Safety of Walking Football in Patients With Type 2 Diabetes
2019年8月20日 更新者：Romeu Mendes、Universidade do Porto
Our main challenge is to develop a novel physical activity intervention to promote exercise participation sustainability and effective health benefits in type 2 diabetes (T2D) population with minimum health risks.
The relevance of this study is supported by four cornerstones: 1) The Portuguese love football and there seems to be a major potential in the implementation of football practice as part of the prevention and treatment of noncommunicable diseases for the middle-aged and elderly Portuguese population; 2) no studies have assessed the feasibility and safety of a walking football exercise program for middle-age and older patients with T2D; 3) the proposed investigation relies on robust methodology; 4) this intervention can have further sustainability with the enrollment of football clubs and primary health care units.
調査の概要
詳細な説明
This work will be a quasi-experimental study where we aim to test the feasibility and safety of walking football in patients with T2D.
The recruitment of participants will be held in primary health care units by Family Medicine medical doctors.
All participants will receive instructions to maintain daily-life routines (lifestyle-related physical activity and dietary pattern), and to continue with usual care (diabetes consultations on primary health care units and pharmacological regimen) along the studies duration.
All participants will receive basic sports material (sports bag, T-shirt, and sports shoes).
Participants will be organized in two teams of 20 players.
Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions).
Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety (acute effects on capillary glycaemia, blood pressure, foot impact, exercise-related injuries and adverse events) and enjoyment.
Exercise intensity will range between light to vigorous.
No submaximal or maximal exercises will be tested.
Cumulative short-term effects will also be analyzed along the three months through pre- and post-study evaluations.
Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.
研究の種類
介入
入学 (実際)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Porto、ポルトガル、4050-600
- Instituto de Saúde Pública da Universidade do Porto
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
50年～70年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
男
説明
Inclusion Criteria:
- diagnosis of type 2 diabetes for at least 12 months;
- glycated hemoglobin bellow 10 %;
- not having started insulin therapy in the previous six months;
- not having started therapy with sulfonylureas in the previous six months;
- major complications of diabetes screened and controlled (diabetic retinopathy, diabetic nephropathy and diabetic foot);
- no symptoms of coronary artery disease;
- no cardiovascular, respiratory and musculoskeletal contraindications to exercise;
- not under cancer treatment (radiotherapy or intravenous chemotherapy);
- without limitations in gait or balance;
- independent living in the community;
- not engaged in supervised exercise;
- non-smokers at least for 6 months.
Exclusion Criteria:
- cardiological stress test with cardiac or hemodynamic problems
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- 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 |
|---|---|
|
実験的：Exercise
Walking football exercise program
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Participants will be organized in two teams of 20 players.
Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions).
Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety and enjoyment.
Exercise intensity will range between light to vigorous.
No submaximal or maximal exercises will be tested.
Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.
|
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 |
|---|---|---|
|
Exercise intensity - subjective internal load
時間枠：Through 3 months
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OMNI rating of perceived exertion scale during exercise (0 [lowest] to 10 [highest] points)
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Through 3 months
|
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Exercise intensity - objective internal load
時間枠：Through 3 months
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Heart rate during exercise
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Through 3 months
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Exercise intensity - external load
時間枠：Through 3 months
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Distance (km) assessed using GPS tracking during exercise
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Through 3 months
|
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Acute glycemic effect
時間枠：Change between before and immediately after each exercise session
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Acute change in capillary blood glucose with exercise sessions
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Change between before and immediately after each exercise session
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Acute systolic blood pressure effect
時間枠：Change between before and immediately after each exercise session
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Acute change in systolic blood pressure with exercise sessions
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Change between before and immediately after each exercise session
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Acute diastolic blood pressure effect
時間枠：Change between before and immediately after each exercise session
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Acute change in diastolic blood pressure with exercise sessions
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Change between before and immediately after each exercise session
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Incidence of falls
時間枠：Through 3 months
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Number of falls during the exercise program
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Through 3 months
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Incidence of foot injuries
時間枠：Through 3 months
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Number of reported foot injuries during the exercise program
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Through 3 months
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Incidence of musculoskeletal injuries
時間枠：Through 3 months
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Number of reported musculoskeletal injuries during the exercise program
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Through 3 months
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Rate of Enjoyment
時間枠：Through 3 months
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Self-reported exercise sessions' enjoyment on a likert scale (1 [lowest] to 5 [highest] points)
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Through 3 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Glycemic control
時間枠：Change from baseline to 3 months
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Glycated hemoglobin (venous blood analysis)
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Change from baseline to 3 months
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Blood lipid profile
時間枠：Change from baseline to 3 months
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Total cholesterol (venous blood analysis)
|
Change from baseline to 3 months
|
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Clinical systolic blood pressure
時間枠：Change from baseline to 3 months
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Resting systolic blood pressure
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Change from baseline to 3 months
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Clinical diastolic blood pressure
時間枠：Change from baseline to 3 months
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Resting diastolic blood pressure
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Change from baseline to 3 months
|
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Body mass index
時間枠：Change from baseline to 3 months
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Body mass index
|
Change from baseline to 3 months
|
|
Waist circumference
時間枠：Change from baseline to 3 months
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Waist circumference
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Change from baseline to 3 months
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Body fat
時間枠：Change from baseline to 3 months
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Body fat (bioelectrical impedance analysis)
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Change from baseline to 3 months
|
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Body lean mass
時間枠：Change from baseline to 3 months
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Body lean mass (bioelectrical impedance analysis)
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Change from baseline to 3 months
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Agility/balance
時間枠：Change from baseline to 3 months
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Timed Up and Go Test
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Change from baseline to 3 months
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Habitual physical activity
時間枠：Change from baseline to 3 months
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Global Physical Activity Questionnaire
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Change from baseline to 3 months
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Food pattern
時間枠：Change from baseline to 3 months
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24h-food recall analysis
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Change from baseline to 3 months
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Cognitive state
時間枠：Change from baseline to 3 months
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Montreal Cognitive Assessment score (0 [lowest] to 30 [highest] points)
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Change from baseline to 3 months
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Health-related quality of life
時間枠：Change from baseline to 3 months
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EQ-5D-5L questionnaire score (0 [lowest] to 100 [highest] points)
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Change from baseline to 3 months
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Medication
時間枠：Change from baseline to 3 months
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Number of medications
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Change from baseline to 3 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
協力者
捜査官
- 主任研究者：Romeu Mendes, MD, PhD、EPIUnit - Instituto de Saúde Pública, Universidade do Porto
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Barbosa A, Brito J, Costa J, Ramos E, Firmino-Machado J, Seabra A, Figueiredo P, Sá MJ, Lunet N, Mendes R. SWEET-FOOTBALL: Development of an evidence-based walking football program for middle-aged and older patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 32.
- Barbosa A, Brito J, Sá MJ, Puga F, Firmino-Machado J, Seabra A, Figueiredo P, Ramos E, Lunet N, Mendes R. Adherence and enjoyment of a walking-football program for patients with type 2 diabetes: SWEET-FOOTBALL Project. In: Bunc V, Tsolakidis E, editors. Book of Abstracts of the 24th Annual Congress of the European College of Sport Science. Prague: ECSS; 2019. p. 120-1.
- Rago V, Brito J, Costa J, Barbosa A, Figueiredo P, Seabra A, Travassos B, Mendes R. Activity profile during walking football training sessions in patients with type 2 diabetes. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern University; 2019. p. 41.
- Costa J, Brito J, Barbosa A, Figueiredo P, Seabra A, Sá MJ, Firmino-Machado J, Ramos E, Mendes R. Nocturnal cardiac autonomic activity in patients with type 2 diabetes engaged in a walking football programme. Football is Medicine Conference 2019 - Programme and Abstracts. Odense: University of Southern Denmark; 2019. p. 39.
- Barbosa A, Brito J, Costa J, Figueiredo P, Seabra A, Mendes R. Feasibility and safety of a walking football program in middle-aged and older men with type 2 diabetes. Prog Cardiovasc Dis. 2020 Nov-Dec;63(6):786-791. doi: 10.1016/j.pcad.2020.06.014. Epub 2020 Jul 4.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年9月17日
一次修了 (実際)
2019年1月31日
研究の完了 (実際)
2019年6月30日
試験登録日
最初に提出
2019年1月10日
QC基準を満たした最初の提出物
2019年1月16日
最初の投稿 (実際)
2019年1月22日
学習記録の更新
投稿された最後の更新 (実際)
2019年8月22日
QC基準を満たした最後の更新が送信されました
2019年8月20日
最終確認日
2019年8月1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。