- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04890080
Resting Heart Rate in Chronic Obstructive Pulmonary Disease
Improvement of Resting Heart Rate After Exercise Training and Its Predictors in Chronic Obstructive Pulmonary Diseases
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In many studies, it has been reported that baroreceptor activity and heart rate variability decrease and resting heart rate (RHR) increases in COPD patients due to changes in cardiac autonomic function. Among the recommendations regarding pulmonary rehabilitation (PR) and exercise training in COPD patients, approaches such as including practices targeting RHR and developing implementation strategies that improve the cardiovascular system are recommended. The primary aim of our study is to examine the effect of comprehensive exercise training consisting of breathing, aerobic and strengthening exercises on RHR in COPD patients, and secondarily to determine the factors that affect RHR change after PR in COPD patients.
110 COPD patients who were participated in the PR program were included in our retrospective study. Resting Heart Rate , pulmonary functions, functional capacity, perception of dyspnea, quality of life and psychological symptoms compared before and after PR.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program
Exclusion Criteria:
- With cardiovascular disease
- With additional diseases such as diabetes
- Receiving medical treatment that affects the autonomic nervous system
- Patients receiving long-term oxygen therapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PR Group
Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program
|
Exercise training consisted of supervised breathing, aerobic, strengthening and stretching exercises for 8 weeks, 2 days a week.
Breathing exercises included pursed lip, diaphragmatic, thoracic expansion and basal expansion exercises.
Strength training included the lower and upper extremities, and it was performed 8-10 repetitions, either against gravity or using free weight, according to patient tolerance.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting Heart Rate
Time Frame: 1 minute
|
number of beats per minute
|
1 minute
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea Assessment
Time Frame: Change from baseline dyspnea at 8 week
|
Medical Research Council Scale(MRC); the MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness.
(min 1- max 5 point) Higher scores mean a worse outcome.
|
Change from baseline dyspnea at 8 week
|
Functional Capacity
Time Frame: Change from baseline six minute walk distance at 8 week
|
Six Minute- walk test
|
Change from baseline six minute walk distance at 8 week
|
Quality of Life Assessment
Time Frame: Change from baseline dyspnea at 8 week
|
St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
|
Change from baseline dyspnea at 8 week
|
Anxiety and Depression
Time Frame: Change from baseline dyspnea at 8 week
|
Hospital Anxiety and Depression (HAD); The HADS questionnaire has seven items each for depression and anxiety subscales.
Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level.
A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
|
Change from baseline dyspnea at 8 week
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- IKC111
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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