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临床试验/NCT06480656
NCT06480656已完成不适用

Eccentric Cycling Exercise During Pulmonary Rehabilitation in Pulmonary Vascular Disease

University of Zurich4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
4
主要终点
peak exercise capacity

研究概览

简要总结

Eccentric cycling allows high intensities with low metabolic costs. Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD

详细描述

Eccentric cycling exercise (ECC) allows training at low metabolic costs and may therefore be valuable for patients with pulmonary vascular disease (PVD). For these patients, regular exercise training has an evidence level 1A recommendation in the current guidelines. Exercise training during longer and regular periods provides chronic adaptation, for which ECC was recently found to have a greater effectiveness than CON by increasing muscle strength, hypertrophy, six-minute walking distance and furthermore, by increasing maximum oxygen uptake (V'O2max) especially in patients with chronic obstructive pulmonary disease (COPD), chronic left heart failure or coronary heart disease.

Furthermore, the investigators conducted an RCT in which the investigators exposed patients with PVD to ECC and concluded that ECC is a feasible and well-tolerated exercise modality for PVD patients with severely lower O2 demand and load to the right ventricle.

Therefore the aim of this project is to investigate whether ECC improves exercise capacity and possibly hemodynamics during prolonged rehabilitation programs in patients with PVD.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed with PVD, either PAH or CTEPH according to recent guidelines
  • Stable medication for at least 1 month
  • Age 18 to 85 years
  • No resting hypoxemia (PaO2 >7.3kPa)

排除标准

  • Any co-morbidity that limits the patient to participate the full rehabilitation
  • Enrollments in other trials with active treatments

研究组 & 干预措施

Eccentric cycling exercise

Experimental

干预措施: Rehabilitation with eccentric cycling exercise (Procedure)

Concentric cycling exercise

Active Comparator

干预措施: normal rehabilitation (Procedure)

结局指标

主要结局

peak exercise capacity

时间窗: 3 weeks

次要结局

  • ventricular - pulmonary arterial coupling(3 weeks)
  • 6 minute walk distance(3 weeks)
  • systolic pulmonary artery pressure(3 weeks)
  • total pulmonary resistance(3 weeks)
  • cardiac output(3 weeks)
  • Borg CR 10 for perceived dyspnea(3 weeks)
  • Peak oxygen uptake(3 weeks)
  • ventilatory equivalent for CO2(3 weeks)
  • Arterial partial pressure for oxygen(3 weeks)
  • Arterial oxygen saturation(3 weeks)
  • Visual analogue scale generell well being(3 weeks)
  • Visual analogue scale dyspnea(3 weeks)
  • Finger pulseoximetry(3 weeks)
  • Borg CR 10 for perceived leg fatigue(3 weeks)
  • Arterial partial pressure for carbon dioxide(3 weeks)
  • Arterial lactate concentration(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Silvia Ulrich Somaini

Prof. Dr. med.

University of Zurich

研究点 (4)

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