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
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease
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
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
NCT ID
NCT03388489
First Posted
December 8, 2017
Last Updated
December 24, 2017
Sponsor
National Taiwan University Hospital
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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