Effects of Different Training Programs in Chronic Disease Patients
Intervention Effects and Safety Evaluation of Different Exercise Training Programs on Hypertension and Hypertension Complicated With Diabetes
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group.Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with diabetes) aged 40-69 years. All exercise sessions will be supervised and subject's exercise implementation process will be managed with intelligent equipment. The purpose of the study is to evaluate the effectiveness and safety of different training programs.
The demographics data, physical activity questionnaires, blood pressure, blood glucose, blood lipids, height, weight and physical fitness （cardiorespiratory fitness，muscle strength, muscle endurance, flexibility, body composition） will be measured before and after 3-month exercise training .The adverse reactions in the implementation of the interventions will be recorded. The primary outcomes are blood pressure and blood glucose.
調査の概要
状態
詳細な説明
The global burden of disease study shows that unreasonable diets and physical inactivity are the largest health risks facing the world today. In recent years, foreign and domestic scholars have gradually introduced the concept of " Exercise is Medicine " guide the the public exercise scientifically. However, under the special cultural background of China, it is urgent to answer how to help the public to realize reasonable scientific exercise, how to choose the popular exercise mode and whether the exercise mode is scientific and effective.
Previous meta-analysis studies on the improvement of blood pressure and blood glucose by walking have been published, but few studies on Chinese square dancing have been conducted. Previous studies on whether Chinese square dancing was scientific and effective were mostly small sample population studies carried out by Chinese scholars. The research results were of large heterogeneity, and the research design lacked reasonable consideration.
This study intends to select two common exercise mode for scientific evaluation, one is walking and the other is Chinese square dancing. The purpose of this study is to evaluate the efficacy and safety of two common types of exercise (walking and Chinese square dancing) in Chinese patients with hypertension and patients with hypertension complicated with diabetes.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Beijing
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Beijing、Beijing、中国、100084
- School of Sport Medicine and Rehabilitation，Beijing Sport University
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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
説明
Inclusion Criteria:
- 40-69 years of age
Meet any one of the two conditions:
2.1 Hypertension: diagnosed with hypertension, systolic blood pressure is 130-159 mmHg, take no antihypertensive drug or no more than 2 kinds of antihypertensive drugs
2.2 Hypertension complicated with diabetes: diagnosed with hypertension and type 2 diabetes, systolic blood pressure is 130-159 mmHg and the fasting blood glucose in the past 2 weeks was 5.6-16.7 mmol/L (13.8-16.7 mmol/L was negative for urinary ketone) , take no more than 4 kinds of antihypertensive and hypoglycemic drugs
- Maintain the current state of medication for the next 3 months
- Lived in the current community in the past six months
- Have no intention of moving out for the next three months
- Have no regular exercise habit (moderate intensity activity less than 3 times a week, less than 30 minutes each time or 30 minutes cumulative), at least exercise 3 days a week
- Sign informed consent
Exclusion Criteria:
- Manual works(such as farmers, couriers, athletes and workers, who rely on physical activity to make a living)
- Physical disability that prevents patients from walking or Chinese square dancing
- Currently enrolled in another lifestyle intervention trial(interventions such as nutrition, psychology, exercise and health education)
- Pregnant or planning to become pregnant
- BMI(body mass index)≥35 kg/m2
- Answers to questions 2, 3 and 6 of the questionnaire in 2014PAR-Q+ are "yes"
- Cardio-cerebrovascular events have occurred in the past 6 months(heart disease diagnosed by doctors, such as coronary heart disease, hypertensive heart disease, acute myocarditis, pulmonary heart disease, etc.)
- Fasting blood glucose of diabetic patients is 13.8-16.7 mmol/L and urinary ketone is positive
- Severe complications of diabetes affecting exercise , such as foot, eye disease and renal insufficiency
- Complicated with other serious chronic diseases such as asthma, malignant tumor, chronic heart failure, severe depression or other mental disorders
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：処理
- 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 |
|---|---|
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実験的：Walking group
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group. Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years. |
Subjects in this group perform exercise consisting of walking for 30 - 60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months .
Each training includes 5 min warm-up and 5 min cool-down, and the exercise should start after meals for 1 hour .
Heart rate is monitored by sports bracelet .
Subjects using β-blockers will not use heart rate to monitor exercise intensity , but RPE scores .
And RPE( Borg scale) scores are ranged from 11-13.
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実験的：Chinese Square Dancing group
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group. Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years. |
Chinese square dances have been selected from 24 sets of square dances jointly launched in 2015 and 2017. According to the age and physical health status of the subjects, six dance pieces of are selected as the repertoires of the intervention in this study. Subjects in this group perform exercise consisting of Chinese square dances for 30-60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months. Each training includes 5 min warm-up and 5 min cool-down , and the exercise should start after meals for 1 hour. Make the subjects step for 30 s to 1 min between each track to adjust the heart rate. Heart rate is monitored by sports bracelet. Subjects using β-blockers will not use heart rate to monitor exercise intensity, but RPE scores. And RPE( Borg scale) scores are ranged from 11-13. |
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実験的：Control group
The study is a randomized 3-month community-based exercise intervention with a control group and 2 different exercise groups: walking group and Chinese square dancing group. Eighteen communities will be selected in Beijing, and they will be age matched and randomly grouped into walking, Chinese square dancing and control groups. Each community will include twenty subjects (ten patients with hypertension and ten patients with hypertension complicated with type 2 diabetes) aged 40-69 years. |
ウォーキンググループ、中国式スクエアダンスグループ、コントロールグループには、月に一度、同じ健康教育パンフレットまたは健康教育講義が与えられます。
パンフレットや講演の具体的な内容としては、2型糖尿病、高血圧関連の医学知識、介入治療の意義、などがあります。 2 型糖尿病、高血圧の予防、栄養と運動の推奨事項。科学的運動に関する基礎知識とその注意事項。
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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 from Baseline Systolic Blood Pressure at 3 months
時間枠：Before and after interventions（3 months)
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To evaluate the effect of walking and Chinese square dancing on systolic blood pressure in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
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Before and after interventions（3 months)
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Change from Baseline Fasting Blood Glucose at 3 months
時間枠：Before and after interventions（3 months）
|
To evaluate the effect of walking and Chinese square dancing on fasting blood glucose in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
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Before and after interventions（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 |
|---|---|---|
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研究完了までの副作用および重篤な有害事象の時間と頻度
時間枠：介入中は研究終了まで毎日（3ヶ月）
|
この研究では、研究関連の副作用や重篤な有害事象などの安全性情報を収集し、CRF に記録します。 関連する定義と手順は次のとおりです。 運動による悪影響には、心血管疾患や脳血管疾患、糖尿病や高血圧に伴う合併症の悪化、スポーツ傷害などがあります。 重篤な有害事象（SAE）は、運動介入後に次のいずれかの結果をもたらす症状として定義されます：死亡、生命を脅かす、入院、永続的または重大な障害、機能不全。 研究中にSAEが発生した場合、研究者は直ちに被験者に適切な治療を施し、試験を終了する必要があります。 副作用について研究者は毎日質問します。 副作用が発生した場合、治験責任医師は、有害事象の時間、重症度、終了時間、講じた措置、および結果を CRF に記録する必要があります。 |
介入中は研究終了まで毎日（3ヶ月）
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Change from Cardiorespiratory Fitness at 3 months
時間枠：Before and after interventions（3 months）
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To evaluate the effect of walking and Chinese square dancing on cardiorespiratory fitness in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Cardiorespiratory fitness (2 minutes high knee lift) is in heart beats per minute.
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Before and after interventions（3 months）
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Change from Muscle Strength at 3 months
時間枠：Before and after interventions（3 months）
|
To evaluate the effect of walking and Chinese square dancing on muscle strength in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Muscle strength (grip strength) is in kilograms.
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Before and after interventions（3 months）
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Change from Muscle Endurance at 3 months
時間枠：Before and after interventions（3 months）
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To evaluate the effect of walking and Chinese square dancing on muscle endurance in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Muscle endurance (40-59 yrs: push-ups(male) or sit-ups(female), 60-69 yrs: 30-second chair stand test and 30-second arm curl test) is in numbers.
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Before and after interventions（3 months）
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Change from Flexibility at 3 months
時間枠：Before and after interventions（3 months）
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To evaluate the effect of walking and Chinese square dancing on flexibility in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Flexibility (40-59 yrs :reach test, 60-69 yrs : chair sit-and-reach test) is in centimeters.
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Before and after interventions（3 months）
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Change from Balance at 3 months
時間枠：Before and after interventions（3 months）
|
To evaluate the effect of walking and Chinese square dancing on balance in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Balance (standing on one leg with eyes closed) is in seconds.
|
Before and after interventions（3 months）
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Change from Body Composition at 3 months
時間枠：Before and after interventions（3 months）
|
To evaluate the effect of walking and Chinese square dancing on body composition in hypertensive patients and patients with hypertension complicated with type 2 diabetes.
Body composition (bioelectrical impedance ) is in percentage of weight.
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Before and after interventions（3 months）
|
協力者と研究者
捜査官
- スタディディレクター：Zhengzhen Wang, Doctor、Beijing Sport Uninversity
研究記録日
主要日程の研究
研究開始 (予想される)
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
本研究に関する用語
その他の研究ID番号
- 2016YFC1300202
個々の参加者データ (IPD) の計画
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