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Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease

Primary Purpose

Chronic Obstructive Pulmonary Disease, Exercise, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mind-Body Walking
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

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

Inclusion Criteria:

1.mild to severe COPD

Exclusion Criteria:

  1. Patients visited the emergency room or were hospitalized previous month;
  2. Long-term oxygen therapy;
  3. Atrial fibrillation;
  4. Severe cognitive impairment;
  5. Great than class II heart failure as defined by the New York Heart Association functional classification in previous six months;
  6. Pacemaker were excluded;
  7. Received cancer treatment
  8. Participated in other exercise trials

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mind-Body Walking

    Usual care

    Arm Description

    breathing, walking and meditation

    maintain their daily activity

    Outcomes

    Primary Outcome Measures

    Change of modified Borg scale for dyspnea level
    The modified Borg scale is a visual tool ranging from 0 (not noticeable) to 10 (maximum dyspnea).

    Secondary Outcome Measures

    Heart rate variability (HRV)
    An HRV monitor (8Z11, Enjoy Research Inc., Taiwan) was used. Participants were instructed to avoid caffeine or other stimulants food before the measurement and to breathe normally in a seated position at rest during the five-minute measurement. Selected parameters of HRV were standard deviation of all NN intervals (SDNN), power in low frequency range (LF, 0.04-0.15 Hz), power in high frequency range (HF, 0.15-0.40 Hz) and LF/HF ratio (Camm et al., 1996). SDNN represented the autonomic function (141±39 for normal value); LF represented both vagal and sympathetic activity (1170±416 for normal value); HF represented vagal control (975±203 for normal value); and LF/HF ratio represented sympatho-vagal balance (0.5~2.5 for normal value) (Camm et al., 1996). The measurements of HRV were taken between 9 a.m. and 5 p.m. to minimize the effect of circadian rhythm on heart rate measurements. The raw data of the measures were used in the study.
    Hospital anxiety and depression scale (HADS) for anxiety and depression
    Hospital anxiety and depression scale (HADS) consists seven items for anxiety and seven items for depression. Four scores (0-3) were designed for each item, with higher score indicating higher anxiety and depression. The score of anxiety or depression domain below 8 indicates no anxiety or depression.
    The Chinese version multidimensional assessment of interoceptive awareness (MAIA-C) for interoceptive awareness
    The Chinese version multidimensional assessment of interoceptive awareness (MAIA-C) included five scales of emotional awareness, attention regulation, body listening, noticing, and self-regulation. Response was rated on six-point Likert scale from 0 (never) to 5 (always), higher scores represented greater interoceptive awareness.
    Six-minute walk distance for exercise capacity
    Six-minute walk distance (6MWD) from the six-minute walk test (American Thoracic Society 2002) was tested. Participants were encouraged to walk as far as possible in six minutes along a flat straight corridor, but they could stop or slow down during the test, if necessary. Longer distances represent greater exercise capacity.
    modified Medical Research Council (mMRC) for perception of dyspnea in daily life
    The modified Medical Research Council (mMRC has five score (0~4), with 0 of "I get breathless when strenuous exercise", and 4 of "I get breathless when dressing or leaving the house". A higher score means higher dyspnea.
    COPD assessment test (CAT) for quality of life
    COPD assessment test (CAT) composes of eight items, including the levels of cough, phlegm (mucus), chest tight, walk up a hill or one flight of stair, limited of activities at home, confident of leaving home, sleep status, and energy. Each item scores 0~5, and a total score is 0~40. A higher score means worse quality of life.

    Full Information

    First Posted
    December 8, 2017
    Last Updated
    December 24, 2017
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03388489
    Brief Title
    Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease
    Official Title
    The Physiological and Psychological Effect of Mind-Body Walking Exercise for Patients With Chronic Obstructive Pulmonary Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    August 18, 2014 (Actual)
    Primary Completion Date
    August 13, 2015 (Actual)
    Study Completion Date
    August 13, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National Taiwan University Hospital

    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
    Mind-body exercise improves symptom of negative moods, dyspnea and quality of life in chronic diseases, but these improvements for chronic obstructive pulmonary disease (COPD) are unproven. This study aims to examine the effects of dyspnea, exercise capacity, heart rate variability(HRV), anxiety, depression, interoceptive awareness, quality of life(QoL) in patients with COPD across a three-month mind-body exercise program.
    Detailed Description
    Chronic obstructive pulmonary disease (COPD) is a progressive disease characterized by airflow limitation, has a high prevalence of morbidity and mortality, and results in negative physical, psychological, and quality of life (QoL) impacts. Patients with COPD typically experience dyspnea, exercise intolerance, autonomic dysfunction, anxiety, depression, and poor QoL. Mind-body intervention with walking, breathing, and mindfulness is beneficial for the health of patients with COPD. However, the result of mind-body walking intervention for patients with COPD is not clear. Thus, this study will evaluate the effects of mind-body walking exercise (MBWE) on the physical psychological wellbeing and QoL of patients with COPD. This study will be a randomized controlled trial. Data will collect from the pulmonary clinics of a medical center in northern Taiwan. The participants will recruit and randomly assign into the MBWE group or the control group. Participants in the control group will receive their usual care. Participants in the MBWE group will receive not only their usual care but also a MBWE program, consisting of walking, breathing, and mindfulness activities, for 30 min per day, 5 days per week, for 8 weeks. Data will collect at baseline and follow up on week 4 (WK 4), week 8 (WK 8), and week 12 (WK12). The primary outcome is dyspnea using modified Borg scale. The secondary outcomes are dyspnea in daily life using modified Medical Research Council (mMRC), exercise capacity using six minute walk distance (6MWD), Heart rate variability (HRV), anxiety and depression using the Hospital Anxiety and Depression scale (HADS), interoceptive awareness using the Multidimensional Assessment of Interoceptive Awareness- Chinese version (MAIA-C), QoL using COPD Assessment Tes (CAT). The independent t-test and Chi-square test were used to examine the homogeneity of the demographic characteristics of two groups. Generalized estimating equations were used to examine the data from repeated measurements.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease, Exercise, Anxiety, Depression, Dyspnea, Quality of Life, Heart Rate Variability

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    84 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mind-Body Walking
    Arm Type
    Experimental
    Arm Description
    breathing, walking and meditation
    Arm Title
    Usual care
    Arm Type
    No Intervention
    Arm Description
    maintain their daily activity
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mind-Body Walking
    Intervention Description
    walking, breathing, and mindfulness
    Primary Outcome Measure Information:
    Title
    Change of modified Borg scale for dyspnea level
    Description
    The modified Borg scale is a visual tool ranging from 0 (not noticeable) to 10 (maximum dyspnea).
    Time Frame
    Baseline and follow up on Week 4, 8, and 12.
    Secondary Outcome Measure Information:
    Title
    Heart rate variability (HRV)
    Description
    An HRV monitor (8Z11, Enjoy Research Inc., Taiwan) was used. Participants were instructed to avoid caffeine or other stimulants food before the measurement and to breathe normally in a seated position at rest during the five-minute measurement. Selected parameters of HRV were standard deviation of all NN intervals (SDNN), power in low frequency range (LF, 0.04-0.15 Hz), power in high frequency range (HF, 0.15-0.40 Hz) and LF/HF ratio (Camm et al., 1996). SDNN represented the autonomic function (141±39 for normal value); LF represented both vagal and sympathetic activity (1170±416 for normal value); HF represented vagal control (975±203 for normal value); and LF/HF ratio represented sympatho-vagal balance (0.5~2.5 for normal value) (Camm et al., 1996). The measurements of HRV were taken between 9 a.m. and 5 p.m. to minimize the effect of circadian rhythm on heart rate measurements. The raw data of the measures were used in the study.
    Time Frame
    Baseline and follow up on Week 4, 8, and 12.
    Title
    Hospital anxiety and depression scale (HADS) for anxiety and depression
    Description
    Hospital anxiety and depression scale (HADS) consists seven items for anxiety and seven items for depression. Four scores (0-3) were designed for each item, with higher score indicating higher anxiety and depression. The score of anxiety or depression domain below 8 indicates no anxiety or depression.
    Time Frame
    Baseline and follow up on Week 4, 8, and 12.
    Title
    The Chinese version multidimensional assessment of interoceptive awareness (MAIA-C) for interoceptive awareness
    Description
    The Chinese version multidimensional assessment of interoceptive awareness (MAIA-C) included five scales of emotional awareness, attention regulation, body listening, noticing, and self-regulation. Response was rated on six-point Likert scale from 0 (never) to 5 (always), higher scores represented greater interoceptive awareness.
    Time Frame
    Baseline and follow up on Week 4, 8, and 12.
    Title
    Six-minute walk distance for exercise capacity
    Description
    Six-minute walk distance (6MWD) from the six-minute walk test (American Thoracic Society 2002) was tested. Participants were encouraged to walk as far as possible in six minutes along a flat straight corridor, but they could stop or slow down during the test, if necessary. Longer distances represent greater exercise capacity.
    Time Frame
    Baseline and follow up on Week 4, 8, and 12.
    Title
    modified Medical Research Council (mMRC) for perception of dyspnea in daily life
    Description
    The modified Medical Research Council (mMRC has five score (0~4), with 0 of "I get breathless when strenuous exercise", and 4 of "I get breathless when dressing or leaving the house". A higher score means higher dyspnea.
    Time Frame
    Baseline and follow up on Week 4, 8, and 12.
    Title
    COPD assessment test (CAT) for quality of life
    Description
    COPD assessment test (CAT) composes of eight items, including the levels of cough, phlegm (mucus), chest tight, walk up a hill or one flight of stair, limited of activities at home, confident of leaving home, sleep status, and energy. Each item scores 0~5, and a total score is 0~40. A higher score means worse quality of life.
    Time Frame
    Baseline and follow up on Week 4, 8, and 12.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 1.mild to severe COPD Exclusion Criteria: Patients visited the emergency room or were hospitalized previous month; Long-term oxygen therapy; Atrial fibrillation; Severe cognitive impairment; Great than class II heart failure as defined by the New York Heart Association functional classification in previous six months; Pacemaker were excluded; Received cancer treatment Participated in other exercise trials
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Feng-Lien Lin, PhD
    Organizational Affiliation
    National Taiwan University Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31192478
    Citation
    Lin FL, Yeh ML, Lai YH, Lin KC, Yu CJ, Chang JS. Two-month breathing-based walking improves anxiety, depression, dyspnoea and quality of life in chronic obstructive pulmonary disease: A randomised controlled study. J Clin Nurs. 2019 Oct;28(19-20):3632-3640. doi: 10.1111/jocn.14960. Epub 2019 Jun 28.
    Results Reference
    derived

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    Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease

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