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Chronic Obstructive Pulmonary DiseaseNCT03388489

Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease

A study testing Mind-Body Walking in people with Chronic Obstructive Pulmonary Disease and Exercise, run by National Taiwan University Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Mind-Body Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
No sites listed yet
Study dates
18 Aug 2014to 13 Aug 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1.mild to severe COPD

Who cannot join

  • 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

About this study

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

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.

Read the 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.

Being tested
Mind-Body Walking
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Motor Activity, Anxiety Disorders, Depression, Dyspnea

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mind-Body WalkingBehavioural

    walking, breathing, and mindfulness

Study groups in NCT03388489
Study groupRoleWhat they receive
Mind-Body WalkingExperimentalbreathing, walking and meditation
Receives: Behavioral: Mind-Body Walking
Usual careNo interventionmaintain their daily activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline and follow up on Week 4, 8, and 12.

Secondary outcomes (6)

  1. 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.

    Measured: Baseline and follow up on Week 4, 8, and 12.

  2. 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.

    Measured: Baseline and follow up on Week 4, 8, and 12.

  3. 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.

    Measured: Baseline and follow up on Week 4, 8, and 12.

  4. 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.

    Measured: Baseline and follow up on Week 4, 8, and 12.

  5. 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.

    Measured: Baseline and follow up on Week 4, 8, and 12.

  6. 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.

    Measured: Baseline and follow up on Week 4, 8, and 12.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2018
  2. Study start18 Aug 2014
  3. Primary completion13 Aug 2015
  4. Study completion13 Aug 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03388489
Sponsor's protocol ID
201312004RIND
Status last verified
Dec 2013
First submitted
8 Dec 2017
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31192478

Questions about this trial

What is this clinical trial studying?

A study testing Mind-Body Walking in people with Chronic Obstructive Pulmonary Disease and Exercise, run by National Taiwan University Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of modified Borg scale for dyspnea level (time frame: Baseline and follow up on Week 4, 8, and 12.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03388489, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018; AzTrials last refreshed its copy on 27 Oct 2026.

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