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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04890080
Other study ID # IKC111
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date April 2021

Study information

Verified date May 2021
Source Izmir Katip Celebi University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

110 COPD patients who were participated in the PR program were included in the study. Resting Heart Rate , pulmonary functions, functional capacity, perception of dyspnea, quality of life and psychological symptoms compared before and after PR.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date April 2021
Est. primary completion date December 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Pulmonary Rehabilitation
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Izmir Katip Celebi University

Outcome

Type Measure Description Time frame Safety issue
Primary Resting Heart Rate number of beats per minute 1 minute
Secondary Functional Capacity Six Minute- walk test Change from baseline six minute walk distance at 8 week
Secondary Dyspnea Assessment 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
Secondary Quality of Life Assessment St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations. Change from baseline dyspnea at 8 week
Secondary Anxiety and Depression 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
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