Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

Not Applicable

Completed

• Conditions: Chronic Pulmonary Disease
• Interventions: Device: Eccentric bike; Device: Helmet ventilation

• Registration Number: NCT05760352
• Lead Sponsor: Fu Jen Catholic University

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-08
• Study Start: 2023-04-14
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-09
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Group: eccentric cycling exercise with helmet ventilation	Eccentric bike	Eccentric cycling exercise combined with helmet ventilation
Intervention Group: eccentric cycling exercise with helmet ventilation	Helmet ventilation	Eccentric cycling exercise combined with helmet ventilation
Intervention Group: eccentric cycling exercise	Eccentric bike	Received eccentric cycling exercise

Primary Outcome Measures

Name	Time	Method
Peak % of oxygen consumption	9 weeks	To observe the maximum exercise performance

Secondary Outcome Measures

Name	Time	Method
Heart rate, b/m	9 weeks	Cardiac hemodynamic parameter
Saturation of Peripheral Oxygen(SpO2), %	9 weeks	Blood oxygenation
Respiratory rate, b/m	9 weeks	Pulmonary parameter
Mean arterial blood pressure, mmHg	9 weeks	Cardiac hemodynamic parameter
FEV1/FVC, %	9 weeks	Pulmonary function

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan