Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

NCT ID: NCT05760352

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-14

Study Completion Date

2024-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

Self-paced exercise

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group: eccentric cycling exercise

Received eccentric cycling exercise

Group Type EXPERIMENTAL

Eccentric bike

Intervention Type DEVICE

Received eccentric cycling exercise

Intervention Group: eccentric cycling exercise with helmet ventilation

Eccentric cycling exercise combined with helmet ventilation

Group Type EXPERIMENTAL

Eccentric bike

Intervention Type DEVICE

Received eccentric cycling exercise

Helmet ventilation

Intervention Type DEVICE

Using helmet ventilation during eccentric cycling exercise

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Eccentric bike

Received eccentric cycling exercise

Intervention Type DEVICE

Helmet ventilation

Using helmet ventilation during eccentric cycling exercise

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FJUH111193

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.