Depression Clinical Trial
Official title:
The Physiological and Psychological Effect of Mind-Body Walking Exercise for Patients With Chronic Obstructive Pulmonary Disease
| NCT number | NCT03388489 |
| Study type | Interventional |
| Source | National Taiwan University Hospital |
| Contact | |
| Status | Completed |
| Phase | N/A |
| Start date | August 18, 2014 |
| Completion date | August 13, 2015 |
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.
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.
