Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease

Depression Clinical Trial

Official title:

The Physiological and Psychological Effect of Mind-Body Walking Exercise for Patients With Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03388489
• Other study ID #: 201312004RIND
• Status: Completed
• Phase: N/A
• First received: December 8, 2017
• Last updated: December 24, 2017
• Start date: August 18, 2014
• Est. completion date: August 13, 2015

Study information

• Verified date: December 2013
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 13, 2015
• Est. primary completion date: August 13, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Chronic Obstructive Pulmonary Disease
• Depression
• Dyspnea
• Exercise
• Heart Rate Variability
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Quality of Life

Intervention

Behavioral:
• Mind-Body Walking
walking, breathing, and mindfulness

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and follow up on Week 4, 8, and 12.
Secondary	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.	Baseline and follow up on Week 4, 8, and 12.
Secondary	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.	Baseline and follow up on Week 4, 8, and 12.
Secondary	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.	Baseline and follow up on Week 4, 8, and 12.
Secondary	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.	Baseline and follow up on Week 4, 8, and 12.
Secondary	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.	Baseline and follow up on Week 4, 8, and 12.
Secondary	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.	Baseline and follow up on Week 4, 8, and 12.