NCT03388489

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Aug 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 18, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2017

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 3, 2018

Completed
Last Updated

January 3, 2018

Status Verified

December 1, 2013

Enrollment Period

12 months

First QC Date

December 8, 2017

Last Update Submit

December 24, 2017

Conditions

Outcome Measures

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).

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

Secondary Outcomes (6)

  • Heart rate variability (HRV)

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

  • Hospital anxiety and depression scale (HADS) for anxiety and depression

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

  • The Chinese version multidimensional assessment of interoceptive awareness (MAIA-C) for interoceptive awareness

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

  • Six-minute walk distance for exercise capacity

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

  • modified Medical Research Council (mMRC) for perception of dyspnea in daily life

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

  • +1 more secondary outcomes

Study Arms (2)

Mind-Body Walking

EXPERIMENTAL

breathing, walking and meditation

Behavioral: Mind-Body Walking

Usual care

NO INTERVENTION

maintain their daily activity

Interventions

walking, breathing, and mindfulness

Mind-Body Walking

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mild to severe COPD

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveMotor ActivityAnxiety DisordersDepressionDyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehaviorMental DisordersBehavioral SymptomsRespiration DisordersSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Feng-Lien Lin, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2017

First Posted

January 3, 2018

Study Start

August 18, 2014

Primary Completion

August 13, 2015

Study Completion

August 13, 2015

Last Updated

January 3, 2018

Record last verified: 2013-12

Data Sharing

IPD Sharing
Will not share