Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

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

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

Study Overview

• Status: Completed
• Conditions: Chronic Pulmonary Disease
• Intervention / Treatment: Device: Eccentric bike; Device: Helmet ventilation

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ke-Yun Chao, PhD; Phone Number: +886-905-301-879; Email: ck_qq@hotmail.com

Study Locations

• Taiwan
  • New Taipei City, Taiwan, 24352
    • Fu Jen Catholic University Hospital, Fu Jen Catholic University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; Self-paced exercise
Experimental: Intervention Group: eccentric cycling exercise; Received eccentric cycling exercise	Device: Eccentric bike; Received eccentric cycling exercise
Experimental: Intervention Group: eccentric cycling exercise with helmet ventilation; Eccentric cycling exercise combined with helmet ventilation	Device: Eccentric bike; Received eccentric cycling exercise; Device: Helmet ventilation; Using helmet ventilation during eccentric cycling exercise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak % of oxygen consumption	To observe the maximum exercise performance	9 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fu Jen Catholic University
• Investigators: Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Actual): February 29, 2024
• Study Completion (Actual): February 29, 2024

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 8, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Pulmonary rehabilitation; Chronic respiratory disease; Eccentric cycling exercise; Helmet ventilation
• Additional Relevant MeSH Terms: Respiration Disorders; Respiratory Tract Diseases
• Other Study ID Numbers: FJUH111193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No