- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06168266
Effects of Eccentric Exercise Training in Patients With COPD
Effects of Smart Eccentric Exercise Training on Lymphocyte Immunity and Erythrocyte Rheology in Patients With Chronic Obstructive Pulmonary Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background: The pathological process of COPD is often accompanied by a decrease in the number and distribution of immune cells in the blood, resulting in immune dysfunction, persistent, multiple infections, and systemic inflammation. Furthermore, the high oxidative stress induced by COPD may also depress the rheological properties of erythrocytes and cause secondary circulatory dysfunction. However, ventilatory limitation and decreased muscle function in COPD patients limit the patients to perform higher-effort exercise therapy. Compared with concentric exercise, eccentric exercise can effectively improve health-related physical fitness and quality of life under lower cardiorespiratory and metabolic loads.
Study Design: This is a three-year project in single center; COPD patients with GOLD grades are recruited in the first year, and then divided into four groups according to GOLD severity grades, and 50 subjects are expected to be recruited; In the second and third year, 120 COPD patients with GOLD grades were recruited.
Methods: This study is expected to recruit 170 subjects, and it will be conducted in the pulmonary rehabilitation treatment room. In the first year, 50 COPD patients with GOLD grade will be recruited, and 20 mL of the venous blood will be drawn during rest for follow-up blood analysis. After that, each subject will perform a serious of functional test, including Six-minute walk test, Timed up-and-go test, Stairs ascending and descending walking time, cardiopulmonary exercise test and isokinetic muscle test. In the second and third year, 60 COPD patients will be recruited respectively, and they will be randomly assigned to the eccentric exercise training and control groups (general care group), each group will carry out the experiment including three stages: control period, training period (and general care group) and maintenance period. During the training period, the eccentric exercise training group will perform 36 eccentric cycling exercises with progressive exercise intensity for 12 weeks, each session about 40 minutes (including 5-min warm-up, 30-min exercise and 5-min relaxation). In the control period, maintenance period and general care group, no exercise intervention will be performed; and in these three experimental periods, 4 functional tests and 4 resting blood draws will be performed.
Effect: This project expects that after 12 weeks of intelligent eccentric exercise training, COPD patients will effectively improve their health-related fitness and quality of life under lower cardiorespiratory and metabolic loads, and will benefit from peripheral blood lymphocytes. Changes in lymphocyte immunity and erythrocyte rheology, to classfy the biological indicators of the course of COPD.
Key words: COPD, Eccentric Exercise Training, Lymphocytes, Mitochondria, Erythrocytes, Rheology
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ke-Yun Chao, PhD
- Phone Number: +886905301879
- Email: C00152@mail.fjuh.fju.edu.tw
Study Locations
-
-
-
New Taipei City, Taiwan, 24352
- Recruiting
- Fu Jen Catholic University Hospital, Fu Jen Catholic University
-
Contact:
- Ke-Yun Chao, PhD
- Phone Number: +886-905-301-879
- Email: ck_qq@hotmail.com
-
Principal Investigator:
- Ke-Yun Chao, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Having undergone pulmonary rehabilitation for more than 3 months
- Sign the written informed consent form
- FEV1/FVC < 0.70
- Approval for exercise training granted by a specialist physician's assessment
- Specialist physician's approval for exercise training
Exclusion Criteria:
- Existing of tracheostomy
- Those who use oxygen therapy or ventilator at home
- Severe 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
- Taking anticoagulant medications
- Other conditions restricting exercise for over a year
- Recent or planned significant cardiovascular surgery or intervention
- Current or planned pregnancy within the next year
- Planned heart transplant within the next six months
- Heart failure due to uncorrectable valvular heart disease, congenital heart disease or obstructive cardiomyopathy
- Inadequate ICD settings for exercise heart rate
- Other exercise contraindications: unstable angina, uncontrolled blood pressure, orthostatic hypotension with symptoms, severe aortic stenosis, acute discomfort or fever, uncontrolled arrhythmias, uncompensated heart failure, acute pericarditis or myocarditis, recent thrombosis or thrombophlebitis, resting ST-segment deviation, uncontrolled diabetes, etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group: eccentric cycling exercise
Received eccentric cycling exercise
|
Received eccentric cycling exercise
|
|
Active Comparator: Control group
Undergoing conventional treatment
|
Received conventional treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
cardiopulmonary oxygen consumption
Time Frame: 12 weeks
|
to observe the maximum exercise performance
|
12 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ke-Yun Chao, PhD, Fu Jen Catholic University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FJUH111246
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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