- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07867535
High-Intensity Interval Alternating Concentric-Eccentric Training in Chronic Respiratory Disease (Effects of Hig)
Effects of High-Intensity Interval Alternating Concentric-Eccentric Training on Functional Performance in Patients With Chronic Respiratory Disease: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effects of high-intensity interval training incorporating alternating concentric and eccentric cycling on functional performance in adults with chronic respiratory disease undergoing pulmonary rehabilitation. A total of 45 participants will be randomly assigned to one of three groups: high-intensity interval alternating concentric-eccentric training, high-intensity interval concentric training, or usual care. Participants in the exercise training groups will complete a 12-week supervised exercise program, while the usual-care group will continue routine care with self-regulated exercise intensity. Functional performance, exercise capacity, and patient-reported outcomes will be assessed before and after the intervention. The study seeks to determine whether incorporating eccentric exercise into high-intensity interval training can improve physical function while reducing cardiopulmonary and perceived exercise burden.
연구 개요
상태
상세 설명
Chronic respiratory diseases, particularly chronic obstructive pulmonary disease (COPD), are commonly associated with exercise intolerance, dyspnea, peripheral muscle dysfunction, and reduced quality of life. Although exercise training is a central component of pulmonary rehabilitation, patients may have difficulty tolerating conventional high-intensity exercise because of ventilatory limitation and leg fatigue.
Eccentric exercise can generate relatively high mechanical workloads with lower oxygen consumption and cardiopulmonary demand than concentric exercise. High-intensity interval training (HIIT), on the other hand, is an effective approach for improving aerobic capacity. This study therefore investigates whether incorporating eccentric cycling into the recovery periods of HIIT can provide additional skeletal muscle stimulation without substantially increasing cardiopulmonary stress.
This is a single-center, prospective, randomized controlled trial conducted at Fu Jen Catholic University Hospital. Forty-five adults with chronic respiratory disease who have participated in pulmonary rehabilitation for more than 3 months will be enrolled and randomly allocated to three groups, with approximately 15 participants in each group: (1) high-intensity interval alternating concentric-eccentric training, (2) high-intensity interval concentric training, or (3) usual care.
Before randomization, participants will undergo graded exercise testing, functional performance assessments, and questionnaires. Participants assigned to the exercise groups will complete supervised training for 12 weeks. The alternating concentric-eccentric group will also undergo an eccentric exercise familiarization period before the formal training program. Participants in the usual-care group will continue routine care with self-regulated exercise intensity for 12 weeks. After the intervention, graded exercise testing, functional assessments, and questionnaires will be repeated.
The study will evaluate changes in functional performance, exercise capacity, muscle function, symptoms, and quality of life to determine whether alternating concentric-eccentric HIIT provides additional benefits compared with conventional concentric HIIT and usual care.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Hui-Wen Hsu, M.S.
- 전화번호: 23426 +886-2-8512-8888
- 이메일: 76wwocat@gmail.com
연구 장소
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New Taipei City
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New Taipei City, New Taipei City, 대만, 24352
- Fu Jen Catholic University Hospital
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연락하다:
- Hui-Wen Hsu, M.S.
- 전화번호: 23426 +886-2-8512-8888
- 이메일: 76wwocat@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Able and willing to provide written informed consent. Adults aged 18 years or older with chronic respiratory disease. Have participated in a pulmonary rehabilitation program for more than 3 months. For participants with an implanted cardioverter-defibrillator (ICD), the programmed maximum heart rate must be higher than the target heart rate used during exercise training.
Considered medically suitable for exercise training by a specialist physician.
Exclusion Criteria:
- Presence of a tracheostomy. Use of long-term home oxygen therapy or home mechanical ventilation. Severe left-sided heart failure classified as New York Heart Association (NYHA) functional class III or IV.
Diagnosis of a neuromuscular disease. Acute exacerbation of chronic obstructive pulmonary disease (COPD) within the previous 3 months.
Unable to complete or cooperate with cardiopulmonary exercise testing.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Alternating Concentric-Eccentric HIIT
Participants will undergo a 2-week eccentric cycling familiarization period followed by 12 weeks of high-intensity interval training. During the high-intensity intervals, concentric cycling will be performed at 80% of peak work rate, while the recovery intervals will use eccentric cycling at the same external workload. |
Participants will complete a 2-week eccentric cycling familiarization period followed by 12 weeks of supervised high-intensity interval training, performed twice weekly. Each formal training session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of eccentric cycling performed at the same external workload as the high-intensity concentric interval.
다른 이름들:
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활성 비교기: Concentric HIIT
Participants will undergo 12 weeks of high-intensity interval concentric cycling training. High-intensity intervals will be performed at 80% of peak work rate, with recovery intervals performed concentrically at 40% of peak work rate. |
Participants will complete 12 weeks of supervised high-intensity interval concentric cycling training, performed twice weekly. Each session lasts approximately 40 minutes and includes a 5-minute warm-up at 30% of peak work rate (Wpeak), 30 minutes of interval training, and a 5-minute cool-down at 30% Wpeak. The interval phase consists of five cycles of 2 minutes of concentric cycling at 80% Wpeak followed by 4 minutes of concentric cycling at 40% Wpeak.
다른 이름들:
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활성 비교기: Usual Care
Participants will continue usual care with self-regulated exercise intensity for 12 weeks. |
Participants will continue usual care with self-regulated exercise intensity for 12 weeks. No structured high-intensity interval or eccentric cycling training will be provided as part of the study intervention. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in 6-Minute Walk Distance
기간: Baseline and 12 weeks
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The 6-minute walk test will be used to assess functional exercise capacity. The distance walked in 6 minutes on a 30-meter indoor corridor will be recorded in meters. Change from baseline to post-intervention will be compared among the three study groups. |
Baseline and 12 weeks
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Change in Timed Up and Go Test
기간: Baseline and 12 weeks
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The Timed Up and Go test will be used to assess functional mobility, balance, and gait performance. Participants will stand from a chair, walk 3 meters, turn, return to the chair, and sit down. Three trials will be performed, and the fastest completion time in seconds will be used for analysis. |
Baseline and 12 weeks
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Change in Stair Climbing Performance
기간: Baseline and 12 weeks
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Stair climbing performance will be assessed using a fixed number of stairs to evaluate lower-extremity strength, balance, agility, and functional performance. Completion time will be recorded in seconds. |
Baseline and 12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in St. George's Respiratory Questionnaire Score
기간: Baseline and after 12 weeks of formal training
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Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ). Changes in total score from baseline to post-intervention will be evaluated. |
Baseline and after 12 weeks of formal training
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공동 작업자 및 조사자
수사관
- 수석 연구원: Hui-Wen Hsu, M.S., Fu Jen Catholic University Hospital
간행물 및 유용한 링크
일반 간행물
- Milanovic Z, Sporis G, Weston M. Effectiveness of High-Intensity Interval Training (HIT) and Continuous Endurance Training for VO2max Improvements: A Systematic Review and Meta-Analysis of Controlled Trials. Sports Med. 2015 Oct;45(10):1469-81. doi: 10.1007/s40279-015-0365-0.
- Inostroza M, Valdes O, Tapia G, Nunez O, Kompen MJ, Nosaka K, Penailillo L. Effects of eccentric vs concentric cycling training on patients with moderate COPD. Eur J Appl Physiol. 2022 Feb;122(2):489-502. doi: 10.1007/s00421-021-04850-x. Epub 2021 Nov 20.
- Chao KY, Liu WL, Hsu HW, Chen HC, Lim AY, Wang JS. Eccentric cycling for chronic respiratory disease: Does helmet ventilation add value? A randomized controlled trial. Chron Respir Dis. 2025 Jan-Dec;22:14799731251404870. doi: 10.1177/14799731251404870. Epub 2025 Nov 25.
- Harrison AJ, Burdon CA, Groeller H, Peoples GE. The Acute Physiological Responses of Eccentric Cycling During the Recovery Periods of a High Intensity Concentric Cycling Interval Session. Front Physiol. 2020 Apr 17;11:336. doi: 10.3389/fphys.2020.00336. eCollection 2020.
- Pancera S, Lopomo NF, Porta R, Sanniti A, Buraschi R, Bianchi LNC. Effects of Combined Endurance and Resistance Eccentric Training on Muscle Function and Functional Performance in Patients With Chronic Obstructive Pulmonary Disease: Randomized Controlled Trial. Arch Phys Med Rehabil. 2024 Mar;105(3):470-479. doi: 10.1016/j.apmr.2023.09.004. Epub 2023 Sep 15.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- FJUH115600
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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