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Resting Heart Rate in Chronic Obstructive Pulmonary Disease

Primary Purpose

Pulmonary Rehabilitation, Exercise, COPD

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
Izmir Katip Celebi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Rehabilitation focused on measuring resting heart rate, COPD, exercise, pulmonary rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    PR Group

    Arm Description

    Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program

    Outcomes

    Primary Outcome Measures

    Resting Heart Rate
    number of beats per minute

    Secondary Outcome Measures

    Functional Capacity
    Six Minute- walk test
    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.
    Quality of Life Assessment
    St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
    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.

    Full Information

    First Posted
    May 12, 2021
    Last Updated
    May 12, 2021
    Sponsor
    Izmir Katip Celebi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04890080
    Brief Title
    Resting Heart Rate in Chronic Obstructive Pulmonary Disease
    Official Title
    Improvement of Resting Heart Rate After Exercise Training and Its Predictors in Chronic Obstructive Pulmonary Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    December 2019 (Actual)
    Study Completion Date
    April 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Izmir Katip Celebi University

    4. Oversight

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

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Rehabilitation, Exercise, COPD, Resting Heart Rate
    Keywords
    resting heart rate, COPD, exercise, pulmonary rehabilitation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    110 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    PR Group
    Arm Type
    Experimental
    Arm Description
    Patients diagnosed with COPD according to GOLD and completed the 2-day / 8-week PR program
    Intervention Type
    Other
    Intervention Name(s)
    Pulmonary Rehabilitation
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Resting Heart Rate
    Description
    number of beats per minute
    Time Frame
    1 minute
    Secondary Outcome Measure Information:
    Title
    Functional Capacity
    Description
    Six Minute- walk test
    Time Frame
    Change from baseline six minute walk distance at 8 week
    Title
    Dyspnea Assessment
    Description
    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.
    Time Frame
    Change from baseline dyspnea at 8 week
    Title
    Quality of Life Assessment
    Description
    St. George Respiratory Questionnaire; Scores range from 0 to 100, with higher scores indicating more limitations.
    Time Frame
    Change from baseline dyspnea at 8 week
    Title
    Anxiety and Depression
    Description
    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.
    Time Frame
    Change from baseline dyspnea at 8 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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