Interval Training in Adults With Congenital Heart Disease a Randomized Trial
Effect of Home Based Interval Training on Exercise Capacity and Quality of Life in Adults With Congenital Heart Disease - a Randomized Controlled Multicenter Trial
調査の概要
詳細な説明
The number adults with congenital heart disease is increasing. Thanks to advances in the medical and surgical fields the number of adults with complex congenital heart disease is now higher than the children with corresponding heart disease. Though the long term prognosis is still unknown and continuously changing as new therapeutic options are introduced.
Persons with congenital heart disease have different degrees of impaired exercise capacity compared to healthy controls. Some studies indicate that this population is not sufficiently active to achieve the recommendations for physical activity in preventing acquired heart disease. Physical inactivity is an important risk factor for developing acquired heart disease and other life style diseases as obesity and diabetes. In a population where one or more previous cardiac surgeries are common, the prevention of life style diseases is especially important. Exercise training in heart failure and coronary artery disease is well studied and there are clinical guidelines. Regarding exercise training in adults with congenital heart disease, however,the information is sparse and further studies are needed.
Based on defined inclusion and exclusion criteria adults with complex congenital heart disease will be recruited in the Northern Health Care Region in Sweden and in Gothenburg. Before and after the twelve week intervention period the investigators will collect information about cardiopulmonary exercise capacity, health related quality of life, exercise self-efficacy, anxiety and depression. The patients will be randomized to twelve weeks of home based interval training or to a control group. The randomization ratio will be 2:1 (intervention:control). The control group will be instructed to continue with their habitual physical activities. The home based interval training program will be individualized based on the results of the exercise tests.
The aim of this study is to examine the effect of home based interval training on maximal and submaximal exercise capacity, quality of life, exercise self-efficacy, anxiety and depression.
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
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Gothenburg、スウェーデン、SE- 413 45
- Sahlgrenska University Hospital
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Umeå、スウェーデン、90185
- University Hospital
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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:
- Complex congenital heart disease (e.g.; Tetralogy of Fallot, Transpositions of the great arteries, Ebstein, Eisenmenger, Pulmonary atresia or Tricuspid atresia)
- Clinically stable without significant change the last 3 months
- Adult (>18 years)
- Informed consent
Exclusion Criteria:
- Signs of arrhythmia on exercise ECG or relevant clinical arrhythmia
- Mental retardation or psychiatric illness affecting the ability of independent decisions
- Other comorbidity affecting physical activity
- Other circumstances making participation unsuitable
- Present strategy of regularly executing physical exercise > 2 times/week in purpose to increase cardiovascular capacity.
- VO2 peak > 30 ml/kg/min
- No access to internet
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
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
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：Home based interval training
12 weeks home based interval training
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The participant in the intervention group will receive an individualized interval training program.
The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt).
The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks.
During exercise they will wear a heart rate monitoring watch.
The registered heart rate will be transferred to a webpage after the exercise session.
Only the physiotherapist and participant have the access to this page.
The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load.
Progression in training load and time will be made when necessary to keep a relevant intensity.
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介入なし：Control group
No structured exercise training.
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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 |
|---|---|---|
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Peak VO2 (ml/kg/min)
時間枠：Before homebased interval exrecise regime and after completion (12 weeks)
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Comparison within and between groups
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Before homebased interval exrecise regime and after completion (12 weeks)
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Endurance time
時間枠：Before homebased interval exercise regimen and at completion (12 weeks)
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at CPET-incremental and constant work rate test at 75% of peak work rate (Watt).
Comparison between and within groups.
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Before homebased interval exercise regimen and at completion (12 weeks)
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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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Response during CPET incremental and constant work rate test at 75% of peak work rate (Watt).
時間枠：Before homebased interval exercise regime and at completion (12 weeks)
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(Peak VO2 (l/min) and Iso time, VCO2, VE/VCO2, VE/VCO2-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart Rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
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Before homebased interval exercise regime and at completion (12 weeks)
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Adverse events
時間枠：Once a week during homebased exercise regime
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Complications to training
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Once a week during homebased exercise regime
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Quality of life
時間枠：Before homebased interval exercise regime and at completion (12 weeks)
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The EQ-5D and SF 36 questionaires will be used to assess Quality of life.
Comparison between and within groups.
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Before homebased interval exercise regime and at completion (12 weeks)
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Physical activity level
時間枠：Before homebased interval exercise regime and after completion (12 weeks)
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The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level.
Comparison within and between groups.
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Before homebased interval exercise regime and after completion (12 weeks)
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Exercise self-efficacy
時間枠：Before homebased interval exercise regime and after completion
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The Exercise Self-Efficacy Scale will be used.
Comparison within and between groups
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Before homebased interval exercise regime and after completion
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Anxiety and depression
時間枠：Before homebased interval exercise regime and after completion (12 weeks)
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The hospital anxiety and depression scale (HAD-scale) will be used to estimate the incidence of anxiety and depression.
Comparison between and within groups.
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Before homebased interval exercise regime and after completion (12 weeks)
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Response during CPET incremental and constant work rate test at 75 % of peak work rate (Watt).
時間枠：12 months after completion
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( Peak VO2 and Iso time(l/min), VCO2, VE/VCO2, VE/VCO-slope, anaerobic threshold, Peak Heart Rate, Heart Rate recovery, Heart rate response, Peak work rate, Oxygen saturation, Blood pressure, symptoms) Comparison within and between groups.
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12 months after completion
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Peak VO2( ml/kg/min)
時間枠：12 months after completion
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Comparison within and between groups
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12 months after completion
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Endurance time
時間枠：12 months after completion
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at CPET incremental and constant work rate at 75% of peak work rate (Watt)
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12 months after completion
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Quality of life
時間枠：12 months after completion
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The EQ-5D and SF 36 questionaires will be used to assess Quality of life.
Comparison within and between groups.
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12 months after completion
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Physical Activity level
時間枠：12 months after completion
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The long self administered version of International Physical Activity Questionaire (IPAQ) will be used to assess physical activity level.
Comparison within and between groups.
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12 months after completion
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Anxiety and depression
時間枠：12 months after completion
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The hospital Anxiety and Depression Scale (HAD-scale) will be used to estimate the incidence of anxiety and depression.
Comparison within and between groups.
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12 months after completion
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Bengt Johansson, MD, Phd、Umeå University
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 (見積もり)
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
- GUCHUmU01
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