Effect of Resistance Training in Adults With Complex Congenital Heart Disease
調査の概要
詳細な説明
The number of adults with complex congenital heart disease is increasing and today they outnumber the children with corresponding lesions. However, the longterm prognosis is still unknown and continuously changing as new therapeutic options are introduced.
Patients with complex congenital heart disease have reduced muscle function compared to healthy controls as well as patients with lesions classified as simple. Furthermore, men with congenital heart disease are more commonly underweight and less commonly overweight obese compared to the general population. In addition, men with complex lesions are shorter in comparison to controls. This indicates an altered body composition i.e. muscle mass, fat mass and bone density in this population. Moreover, impaired muscle metabolism has been reported in patients palliated with Fontan procedure.
Adult patients with complex congenital heart disease will be recruited based on defined inclusion and exclusion criteria. Muscle function, muscle strength, muscle metabolism and body composition will be evaluated before randomisation and at follow-up after twelve weeks. The patients will be randomised to twelve weeks of home based resistance training or to a control group. The randomisation ratio will be 1:1 ( intervention:control). The control group will be instructed to continue with their habitual physical activities. The resistance training protocol will be individualised based on the results of the muscle function and muscle strength tests.
The aim of this study is to investigate the effects of resistance training on muscle function, muscle strength, body composition and muscle metabolism in adults with complex congenital heart disease.
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
-
-
-
Lund、スウェーデン、22185
- 完了
- Skane University Hospital
-
Umeå、スウェーデン、90185
- 募集
- University Hospital
-
コンタクト：
- Bengt Johansson, MD, PhD
- 電話番号：+46907852782
- メール：bengt.johansson@medicin.umu.se
-
コンタクト：
- Camilla Sandberg, RPT, PhD
- 電話番号：+46907858441
- メール：camilla.sandberg@medicin.umu.se
-
主任研究者：
- Bengt Johansson, MD, PhD
-
副調査官：
- Camilla Sandberg Sandberg, RPT, PhD
-
Uppsala、スウェーデン
- 募集
- University hospital Uppsala
-
コンタクト：
- Christina Christersson, MD, Phd
-
-
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, transposition of the great arteries, pulmonary atresia, patients palliated with Fontan procedure or total cavo-pulmonary connection).
- Clinically stable without significant change the last 3 months.
- Adult (> 18 years of age).
- Informed consent.
Exclusion Criteria:
- Cognitive impairment affecting the ability of independent decision making.
- Present strategy of regularly executing resistance training > 2times per week in purpose to increase muscle strength.
- Other comorbidity affecting physical activity.
- Other circumstance making participation unsuitable.
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Resistance training
Home based resistance training 12 weeks home based resistance training 3 times per week, 10-12 reps, 2 sets
|
The participants in the intervention group will receive an individualized resistance training program.
The individual adjustments in load will will be made from the results of the muscle function and muscle strength tests.
The resistance training will be home based and performed 3 times per week 10-12 reps 2 sets 12 weeks.
Increment of load will be performed continuously according to rating of perceived exertion.
|
|
介入なし：Control group
No instructed exercise training.
Continue with habitual 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 in muscle strength (Newton, N)
時間枠：Change from baseline muscle strength at 12 weeks follow-up
|
Change from baseline muscle strength at 12 weeks follow-up
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in muscle endurance (number of repetitions)
時間枠：Change from baseline muscle endurance at 12 weeks follow-up
|
Change from baseline muscle endurance at 12 weeks follow-up
|
|
|
Change in total body skeletal muscle mass (kg)
時間枠：Change from baseline total body skeletal muscle mass at 12 weeks follow-up
|
Using dual-energy x-ray absorptiometry (DEXA)
|
Change from baseline total body skeletal muscle mass at 12 weeks follow-up
|
|
Change in appendicular skeletal muscle mass (kg)
時間枠：Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
|
Using dual-energy x-ray absorptiometry (DEXA)
|
Change from baseline appendicular skeletal muscle mass at 12 weeks follow-up
|
|
Change in body fat percentage
時間枠：Change from baseline body fat percentage at 12 weeks follow-up
|
Using dual-energy x-ray absorptiometry (DEXA)
|
Change from baseline body fat percentage at 12 weeks follow-up
|
|
Change in bone mineral density (g/cm2)
時間枠：Change from baseline bone mineral density at 12 weeks follow-up
|
Using dual-energy x-ray absorptiometry (DEXA)
|
Change from baseline bone mineral density at 12 weeks follow-up
|
|
Muscle metabolism
時間枠：Change from baseline muscle metabolism at 12 weeks follow-up
|
near infrared spectroscopy (NIRS)
|
Change from baseline muscle metabolism at 12 weeks follow-up
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Compliance to study protocol
時間枠：At completion of study protocol 12 weeks
|
number of training sessions
|
At completion of study protocol 12 weeks
|
|
Adverse events
時間枠：Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
|
Complications to resistance training
|
Once a week from the date of onset of the home based exercise regimen until the followup at 12 weeks
|
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
出版物と役立つリンク
一般刊行物
- Williams CA, Wadey C, Pieles G, Stuart G, Taylor RS, Long L. Physical activity interventions for people with congenital heart disease. Cochrane Database Syst Rev. 2020 Oct 28;10(10):CD013400. doi: 10.1002/14651858.CD013400.pub2.
- Cordina R, O'Meagher S, Gould H, Rae C, Kemp G, Pasco JA, Celermajer DS, Singh N. Skeletal muscle abnormalities and exercise capacity in adults with a Fontan circulation. Heart. 2013 Oct;99(20):1530-4. doi: 10.1136/heartjnl-2013-304249. Epub 2013 Jul 11. Erratum In: Heart. 2013 Dec;99(23):1788. Singh, Nalin [added].
- Sandberg C, Thilen U, Wadell K, Johansson B. Adults with complex congenital heart disease have impaired skeletal muscle function and reduced confidence in performing exercise training. Eur J Prev Cardiol. 2015 Dec;22(12):1523-30. doi: 10.1177/2047487314543076. Epub 2014 Jul 18.
- Kroonstrom LA, Johansson L, Zetterstrom AK, Dellborg M, Eriksson P, Cider A. Muscle function in adults with congenital heart disease. Int J Cardiol. 2014 Jan 1;170(3):358-63. doi: 10.1016/j.ijcard.2013.11.014. Epub 2013 Nov 13.
- Sandberg C, Rinnstrom D, Dellborg M, Thilen U, Sorensson P, Nielsen NE, Christersson C, Wadell K, Johansson B. Height, weight and body mass index in adults with congenital heart disease. Int J Cardiol. 2015;187:219-26. doi: 10.1016/j.ijcard.2015.03.153. Epub 2015 Mar 18.
研究記録日
主要日程の研究
研究開始
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 (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。