Comparison of Multiple Exercise Trainings for Accessing Maximal Oxygen Consumption in Patients With Chronic Respiratory Disease

Sponsor

Fu Jen Catholic University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05760352

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Pulmonary Disease	Device: Eccentric bike Device: Helmet ventilation	N/A

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： We 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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Dec 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Peak oxygen consumption [9 weeks]
To observe the maximum exercise performance

Secondary Outcome Measures

Heart rate [9 weeks]
Cardiac hemodynamic parameter
Respiratory rate [9 weeks]
Pulmonary parameter
Blood pressure [9 weeks]
Cardiac hemodynamic parameter
FEV1/FVC [9 weeks]
Pulmonary function
Saturation of Peripheral Oxygen(SpO2) [9 weeks]
Blood oxygenation

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients with chronic respiratory diseases who have received pulmonary rehabilitation for more than 3 months FEV1/FVC is less than 0.7 FEV1 is less than 80% of predicted value

Exclusion Criteria:

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