Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke
Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study
調査の概要
詳細な説明
Cycle ergometer training is one of the common indoor aerobic exercises for enhancing cardiorespiratory fitness in patients after stroke. However, studies had suggested that patients may be undertrained for reasons such as a tight time schedule for other rehabilitation programs and lack of objective evaluation on the training intensity.
To address the issue of inadequate cycle ergometer training in poststroke patients, in this study, an intelligent cardiopulmonary rehabilitation system was developed and incorporated into a bicycle ergometer, allowing dynamically auto-adjust paddling resistance considering the instant heart rate and cadence, with a goal to maintain the hear rate within the pre-determined heart rate zone. The purpose of the current study is to investigate the feasibility of the ICRS in stroke patients and whether it outweighs the traditional feedback on training intensity.
A single-blind crossover trial is adopted with 40 participants estimated to be recruited and randomly assigned to the group A and group B. Group A received training with ICRS while Group B received training with TAET at the beginning. The intensity of ICRS is set as 60%~80% heart rate reserve (HRR) which is obtained from cardiopulmonary exercise testing (CPET) at pretest. The intensity of TAET is set as subjective rating of perceived exertion at "somewhat hard" to "hard" level. Both groups will receive 30 minutes of training per session, 3 sessions a week for four weeks followed by a washout period of 4-week break. Subjects are crossed-over to the alternate treatment afterwards. CPET evaluations will be conducted in a total of 4 times before and after treatment.
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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New Taipei City、台湾
- 募集
- Wanfang Hospital
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コンタクト:
- Yen-Nung Lin, MD, MS
- 電話番号:0970746879
- メール:semitune@gmail.com
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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:
- Aged 20-75 y/o
- Healthy people
- Chronic stroke > 6 months
- Able to walk independently > 6 minutes with or without orthosis
- Able to use stationary bike
- MRS(Modified Rankin Scale) ranged 1 to 3
Exclusion Criteria:
- Patients whose heart rate can not be used as the indicator of training intensity (eg, ar-rhythmia, atrial fibrillation, beta-blockers users)
- With any reason that the patient is not suitable to undergo aerobic training
- Patients who are unable to do cycling due to musculoskeletal problems
- Patients who can not follow the instruction of trainers due to cognitive or emotional-problems.
- Patients whose medical condition is not unstable.
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:クロスオーバー割り当て
- 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:Intelligent cardiopulmonary rehabilitation system (ICRS)
The ICRS is very likely to the conventional stationary biking, but with an algorithm that automatically controls the resistance of pedalling, considering the instant heart rate and cadence, to keep the heart rate within the targeted heart rate zone.
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Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
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アクティブコンパレータ:Traditional aerobic exercise training (TAET)
The TAET is performed with stationary biking, with intensity being set as subjective rating of perceived exertion at a "somewhat hard" to "hard" level.
The resistance of pedaling is ad-justed by the user or physical therapist.
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Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.
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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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relative VO2-peak (mL/kg/min)
時間枠:4 weeks
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oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
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4 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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6-min walk test
時間枠:4 weeks
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The 6-minute walk test measures the distance covered while walking at a tolerable pace for 6 minutes.
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4 weeks
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absolute VO2-peak (mL/min)
時間枠:4 weeks
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oxygen consumption (VO2- peak) is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
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4 weeks
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workload-peak (Watt)
時間枠:4 weeks
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The peak workload is measured during a the cardiopulmonary exercise test with a ramped stationary biking.
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4 weeks
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協力者と研究者
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
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