Clinical trial NCT03388489: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Exercise
Anxiety
Depression
Dyspnea
Quality of Life
Heart Rate Variability
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-01-03
Enrollment: 84
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of modified Borg scale for dyspnea level
timeFrame: Baseline and follow up on Week 4, 8, and 12.
Secondary outcomes:
measure: Heart rate variability (HRV)
timeFrame: Baseline and follow up on Week 4, 8, and 12.
measure: Hospital anxiety and depression scale (HADS) for anxiety and depression
timeFrame: Baseline and follow up on Week 4, 8, and 12.
measure: The Chinese version multidimensional assessment of interoceptive awareness (MAIA-C) for interoceptive awareness
timeFrame: Baseline and follow up on Week 4, 8, and 12.
measure: Six-minute walk distance for exercise capacity
timeFrame: Baseline and follow up on Week 4, 8, and 12.
measure: modified Medical Research Council (mMRC) for perception of dyspnea in daily life
timeFrame: Baseline and follow up on Week 4, 8, and 12.
measure: COPD assessment test (CAT) for quality of life
timeFrame: Baseline and follow up on Week 4, 8, and 12.
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Feng-Lien Lin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.