Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease

NCT ID: NCT03388489

Last Updated: 2018-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-18
• Study Completion Date: 2015-08-13

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.

Conditions

Chronic Obstructive Pulmonary Disease; Exercise; Anxiety; Depression; Dyspnea; Quality of Life; Heart Rate Variability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Mind-Body Walking

breathing, walking and meditation

Group Type: EXPERIMENTAL

Mind-Body Walking

Intervention Type: BEHAVIORAL

walking, breathing, and mindfulness

Usual care

maintain their daily activity

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mind-Body Walking

walking, breathing, and mindfulness

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Feng-Lien Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

References

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.

Reference Type: DERIVED

PMID: 31192478 (View on PubMed)

Other Identifiers

201312004RIND

Identifier Type: -

Identifier Source: org_study_id