Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

Chronic Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05760352
• Other study ID #: FJUH111193
• Status: Completed
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: February 29, 2024

Study information

• Verified date: March 2024
• Source: Fu Jen Catholic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 29, 2024
• Est. primary completion date: February 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pulmonary Disease
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Device:
• Eccentric bike
Received eccentric cycling exercise
• Helmet ventilation
Using helmet ventilation during eccentric cycling exercise

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak % of oxygen consumption	To observe the maximum exercise performance	9 weeks
Secondary	Heart rate, b/m	Cardiac hemodynamic parameter	9 weeks
Secondary	Respiratory rate, b/m	Pulmonary parameter	9 weeks
Secondary	Mean arterial blood pressure, mmHg	Cardiac hemodynamic parameter	9 weeks
Secondary	FEV1/FVC, %	Pulmonary function	9 weeks
Secondary	Saturation of Peripheral Oxygen(SpO2), %	Blood oxygenation	9 weeks