- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04833400
Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke
Intelligent Cardiopulmonary Rehabilitation System for Patients With Chronic Stroke: a Feasibility Study
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Taipei City, 대만
- 모병
- WanFang Hospital
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연락하다:
- Yen-Nung Lin, MD, MS
- 전화번호: 0970746879
- 이메일: semitune@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
relative VO2-peak (mL/kg/min)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
6-min walk test
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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