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Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

Primary Purpose

Chronic Pulmonary Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Eccentric bike
Helmet ventilation
Sponsored by
Fu Jen Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Pulmonary Disease focused on measuring Pulmonary rehabilitation, Eccentric cycling exercise, Helmet ventilation, Chronic respiratory disease

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fu Jen Catholic University Hospital, Fu Jen Catholic UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Intervention Group: eccentric cycling exercise

Intervention Group: eccentric cycling exercise with helmet ventilation

Arm Description

Self-paced exercise

Received eccentric cycling exercise

Eccentric cycling exercise combined with helmet ventilation

Outcomes

Primary Outcome Measures

Peak % of oxygen consumption
To observe the maximum exercise performance

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2023
Last Updated
October 9, 2023
Sponsor
Fu Jen Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT05760352
Brief Title
Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
July 12, 2023 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Jen Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pulmonary Disease
Keywords
Pulmonary rehabilitation, Eccentric cycling exercise, Helmet ventilation, Chronic respiratory disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Self-paced exercise
Arm Title
Intervention Group: eccentric cycling exercise
Arm Type
Experimental
Arm Description
Received eccentric cycling exercise
Arm Title
Intervention Group: eccentric cycling exercise with helmet ventilation
Arm Type
Experimental
Arm Description
Eccentric cycling exercise combined with helmet ventilation
Intervention Type
Device
Intervention Name(s)
Eccentric bike
Intervention Description
Received eccentric cycling exercise
Intervention Type
Device
Intervention Name(s)
Helmet ventilation
Intervention Description
Using helmet ventilation during eccentric cycling exercise
Primary Outcome Measure Information:
Title
Peak % of oxygen consumption
Description
To observe the maximum exercise performance
Time Frame
9 weeks
Secondary Outcome Measure Information:
Title
Heart rate, b/m
Description
Cardiac hemodynamic parameter
Time Frame
9 weeks
Title
Respiratory rate, b/m
Description
Pulmonary parameter
Time Frame
9 weeks
Title
Mean arterial blood pressure, mmHg
Description
Cardiac hemodynamic parameter
Time Frame
9 weeks
Title
FEV1/FVC, %
Description
Pulmonary function
Time Frame
9 weeks
Title
Saturation of Peripheral Oxygen(SpO2), %
Description
Blood oxygenation
Time Frame
9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ke-Yun Chao, PhD
Phone
+886-905-301-879
Email
ck_qq@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ke-Yun Chao, PhD
Organizational Affiliation
Fu Jen Catholic University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fu Jen Catholic University Hospital, Fu Jen Catholic University
City
New Taipei City
ZIP/Postal Code
24352
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ke-Yun Chao, PhD
Phone
+886-905-301-879
Email
ck_qq@hotmail.com
First Name & Middle Initial & Last Name & Degree
Ke-Yun Chao, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Multiple Exercise Trainings in Chronic Respiratory Disease

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