ClinicalTrials.gg
CompletedNCT03388489Updated Jan 3, 2018

Mind-Body Walking Exercise for Chronic Obstructive Pulmonary Disease

An interventional study of Mind-Body Walking in Chronic Obstructive Pulmonary Disease, Exercise and Anxiety, sponsored by National Taiwan University Hospital. Completed. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2018-01-03.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 3 months after the study started (first participant enrolled Aug 2014, registered Dec 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Pulmonary Disease, Chronic Obstructive by National Taiwan University Hospital — 1 open to participants now, 1 under way, none of them phase 3. Pulmonary Disease, Chronic Obstructive · National Taiwan University Hospital.

Started
2014
the only one that year
No phase
5 of 10
1 open now
Registered
4th of 10
by date

Among the 10 studies in Pulmonary Disease, Chronic Obstructive by National Taiwan University Hospital, this one is the only one that started in 2014, is one of 5 with no phase, and was the 4th registered.

Pulmonary Disease, Chronic Obstructive

5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.

Browse Pulmonary Disease, Chronic Obstructive studies →

Open to participants now

1 of the 10 studies in Pulmonary Disease, Chronic Obstructive by National Taiwan University Hospital is open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

Where they have run

Who these studies take

Of the 555 Pulmonary Disease, Chronic Obstructive studies recruiting now, 305 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 87 take healthy volunteers.

This study: 40 Years and older · all sexes · no healthy volunteers.

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02

Study 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.

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.

03

Conditions studied

  • Chronic Obstructive Pulmonary Disease
  • Exercise
  • Anxiety
  • Depression
  • Dyspnea
  • Quality of Life
  • Heart Rate Variability
04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

1.mild to severe

Exclusion criteria

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 functional classification in previous six months;
  6. Pacemaker were excluded;
  7. Received cancer treatment
  8. Participated in other exercise trials
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Care provider)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    Mind-Body Walking

    breathing, walking and meditation

    Behavioral: Mind-Body Walking

  • No intervention
    Usual care

    maintain their daily activity

Interventions

  • BehavioralMind-Body Walking

    walking, breathing, and mindfulness

06

What researchers measure

Primary outcomes

  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).

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

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2014 to primary completion in Aug 2015, 11 months.

Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 11 months is below that.

Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 8, 2017
First posted
Jan 3, 2018
StartActual
Aug 18, 2014
Primary completionActual
Aug 13, 2015
CompletionActual
Aug 13, 2015
Last update
Jan 3, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03388489
Responsible party
Sponsor
First posted
Jan 3, 2018
Start date
Aug 18, 2014
Primary completion
Aug 13, 2015
Completion
Aug 13, 2015
Last update
Jan 3, 2018

Study contacts

Feng-Lien Lin, PhD
principal investigator · National Taiwan University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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