- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07815366
Effectiveness of Eccentric Cycling Exercise in Ambulatory Rehabilitation for Patients With Cardiopulmonary Diseases: A Pragmatic Randomized Controlled Trial
In eccentric cycling exercise (ECC), the cyclist must oppose backwards moving pedals on a specialized motor-driven ergometer. Throughout this process, the force applied on the pedals exceeds the torque generated by the lengthening muscle (negative work), concurrently generating and storing elastic recoil energy . During ECC the cyclist is able to reach fourfold higher forces compared to conventional concentric cycling exercise (CON). At identical work-rates however, ECC is associated with a lower cardiac output 5 and requires up to 80% less oxygen uptake than CON. Hence, ECC is described as a promising and efficient exercise method with low metabolic costs. ECC exhibits greater effectiveness compared to CON, especially in terms of increasing muscle strength, muscle hypertrophy, six-minute walk distance (6MWD).
Acute studies during cycle ergometries have proven that ECC is effective to provide exercise at beneficial levels with low metabolic demand, even at low intensities in patients with chronic cardiopulmonary conditions, such as pulmonary hypertension or COPD.
However, whether these benefits can be achieved in a real world setting such as an ambulatory rehabilitation is unknown. Therefore, the rational of the study is to evaluate the effectiveness of ECC vs. standard training in healthy individuals during a three-month time period.
연구 개요
상세 설명
In eccentric cycling exercise (ECC), the cyclist must oppose backwards moving pedals on a specialized motor-driven ergometer. Throughout this process, the force applied on the pedals exceeds the torque generated by the lengthening muscle (negative work), concurrently generating and storing elastic recoil energy. During ECC the cyclist is able to reach fourfold higher forces compared to conventional concentric cycling exercise (CON) . At identical work-rates however, ECC is associated with a lower cardiac output 5 and requires up to 80% less oxygen uptake 6 than CON. Hence, ECC is described as a promising and efficient exercise method with low metabolic costs. Some studies suggests that ECC may exhibit greater effectiveness compared to CON, especially in terms of increasing muscle strength, muscle hypertrophy, six-minute walk distance (6MWD).
A loss in muscle mass and sarcopenia is present also in the non-diseased population and is increasing with age. A yearly loss of muscle mass in the general population is around 1% at the age of 40 and increases to 2% at the age of 70. This loss in muscle mass can be accelerated in patients with chronic cardiopulmonary diseases and especially in patients with lung cancer undergoing systemic therapies, mainly as chemotherapy.
A recent systematic review with meta-analysis, including studies with a total of 867 patients with lung cancer, conclusively demonstrated that patients undergoing chemotherapy are at risk for a marked loss of skeletal muscle mass and sarcopenia.14 Another study found in around 50% of their lung cancer patients receiving chemotherapy a significant reduction in muscle cross sectional area.15 Sarcopenia has a high burden of disease and has been found to be associated with significant lower survival in patients, as well as with a range of negative outcomes including disability, frailty, morbidity, and reduced quality of life. To prevent sarcopenia patients with cardiopulmonary disease, and patients undergoing chemotherapy should perform regular exercise training. Supervised exercise training and three months of rehabilitation have been shown to be effective, safe and well-tolerated in patients with chronic cardiopulmonary or pulmonary vascular disease. Therefore, a three-month ambulatory rehabilitation program provides a reliable option for these patients to exercise regularly in a supervised setting.
However, patients with advanced cardiopulmonary diseases, such as chronic obstructive pulmonary disease, heart failure, pulmonary hypertension, interstitial lung disease, or advanced stage lung cancer, often suffer from exercise intolerance. In patients whose cardiopulmonary limitations are so severe that they cannot even reach beneficial exercise intensities, the value of an ambulatory rehabilitation program needs to be carefully considered.
Nevertheless, with the features of ECC, even these patients are able to exercise at beneficial levels while maintaining a low metabolic demand. Previous studies have shown that ECC can be effective, even at low intensities, in patients with chronic cardiopulmonary conditions such as pulmonary hypertension or chronic obstructive pulmonary disease. Interestingly, patients additionally reported less perceived dyspnea with unchanged leg fatigue. Furthermore, ECC was associated with reduced pulmonary arterial pressure and improved right ventricular function.
However, whether these benefits can be achieved in a real world setting such as an ambulatory rehabilitation is unknown. Therefore, the rational of the study is to evaluate the effectiveness of ECC on healthy individuals during a three-month training period.
To study potential underlying physiology and effects of ECC in higher exercise intensities, we will also include an exploratory healthy control group that will train similarly as patients with cardiopulmonary disease on the ECC during three month.
This trial investigates the healthy control group.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Canton of Zurich
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Zurich, Canton of Zurich, 스위스, 8091
- Universitätsspital Zürich
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Healthy participants without known Cardiopulmonary disease.
- Provided written informed consent
- Wiling to voluntarily exercise for 3 month on the eccentric ergometer without a specific indication for rehabilitation
Exclusion Criteria:
- Inability to follow the exercise procedure.
- Vulnerable participants (e.g. minors, participants incapable of judgment or participants under tutelage) will not be included into the study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Eccentric cycling
Eccentric cycling for three month
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Participants exercise for three month on an eccentric ergometer
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak work rate
기간: Pre and post the three month exercise persiod
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Peak work rate will be measured using standardized cardiopulmonary exercise testing on a cycling ergometer.
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Pre and post the three month exercise persiod
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Peak oxygen uptake
기간: Pre and post the three month exercise period.
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Peak oxygen uptake will be measured using standardized cardiopulmonary exercise testing on a cycling ergometer.
The participant is connected with a metabolic unit via mouth peace.
Oxygen uptake will be measured breath by breath.
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Pre and post the three month exercise period.
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Patient reported perceived dyspnea at peak exercise
기간: Pre and post three month exercise period
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Patient reported perceived dyspnea at peak exercise will be measured using the Borg 10 item scale during standardized cardiopulmonary exercise testing on a cycling ergometer.
At peak exercise the participant will be ask on a scale from 1 to 10 how he would rate the dyspnea
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Pre and post three month exercise period
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Patient reported perceived leg fatigue
기간: Pre and post three month exercise period.
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Patient reported perceived leg fatigue at peak exercise will be measured using the Borg 10 item scale during standardized cardiopulmonary exercise testing on a cycling ergometer.
At peak exercise the participant will be ask on a scale from 1 to 10 how he would rate the leg fatigue.
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Pre and post three month exercise period.
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Peak quadriceps extension force
기간: Pre and post three month exercise period.
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The peak force that the quadriceps can produce during knee extension is measured on a isokinet.
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Pre and post three month exercise period.
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .