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临床试验/NCT05760352
NCT05760352已完成不适用

Comparison of Multiple Methods of Exercise Training for Accessing Maximal Oxygen Consumption, Skeletal Muscle Oxygen Saturation, and Cardiopulmonary Outcomes in Patients With Chronic Respiratory Disease

Fu Jen Catholic University1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2023年4月14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
44
试验地点
1
主要终点
Peak % of oxygen consumption

研究概览

简要总结

The present study aims to investigate the effect of different exercise training in patients with chronic respiratory disease.

详细描述

Background: Chronic respiratory and chronic obstructive pulmonary disease is the one of the major causes of global morbidity and mortality. Patients with chronic respiratory disease often experience exercise limitation and physical inactivity due to muscular weakness and severe dyspnea. Symptoms of COPD may contribute to activity restriction, deconditioning, and exercise intolerance. Pulmonary rehabilitation has been demonstrated to improve clinical outcomes and exercise capacity in patients with chronic respiratory disease. However, the optimal exercise training modality is remaining unclear.

Study Design: This is a one-year, single-centre, prospective randomized controlled trial

Methods: The investigators expected a total of 60 participants were be enrolled, then randomly assigned into three groups (control group, experimental-1, and experimental-2). All participants will receive a graded exercise test, then followed a 9-weeks of exercise training. After 9-weeks of exercise training, the maximal oxygen consumption will be analyzed as a primary outcome of this study. Physiological parameters, hemodynamic outcome, respiratory function, and strength of lower limb muscle will be recorded.

Effect: After 9 weeks' exercise training, VO2 will significantly improve in eccentric cycling exercise groups, furthermore, heart rate and perceived exertion will be lower in the eccentric cycling exercise combined with helmet ventilation.

Key words: Pulmonary rehabilitation; eccentric cycling exercise; helmet ventilation; chronic respiratory disease

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 20 and 80 years
  • •Diagnosed with chronic respiratory diseases
  • •Having undergone pulmonary rehabilitation for more than 3 months

排除标准

  • •Existing of tracheostomy
  • •Those who use oxygen therapy or ventilator at home
  • •Severe left heart failure (NYHA III-IV)
  • •Neuromuscular disease
  • •Acute exacerbation within the past three months
  • •Those who are unable to cooperate with the cardiopulmonary exercise test

研究组 & 干预措施

Control group

No Intervention

Self-paced exercise

Intervention Group: eccentric cycling exercise

Experimental

Received eccentric cycling exercise

干预措施: Eccentric bike (Device)

Intervention Group: eccentric cycling exercise with helmet ventilation

Experimental

Eccentric cycling exercise combined with helmet ventilation

干预措施: Eccentric bike (Device)

Intervention Group: eccentric cycling exercise with helmet ventilation

Experimental

Eccentric cycling exercise combined with helmet ventilation

干预措施: Helmet ventilation (Device)

结局指标

主要结局

Peak % of oxygen consumption

时间窗: 9 weeks

To observe the maximum exercise performance

次要结局

  • Heart rate, b/m(9 weeks)
  • Saturation of Peripheral Oxygen(SpO2), %(9 weeks)
  • Respiratory rate, b/m(9 weeks)
  • Mean arterial blood pressure, mmHg(9 weeks)
  • FEV1/FVC, %(9 weeks)

研究者

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

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

研究点 (1)

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