NCT01551953

Brief Summary

The main purpose of this study is to determine feasibility and effects of tai chi and mind-body breathing in patients with COPD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
124

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2011

Longer than P75 for phase_2

Geographic Reach
1 country

2 active sites

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

February 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2012

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

February 27, 2017

Status Verified

February 1, 2017

Enrollment Period

5.2 years

First QC Date

March 1, 2012

Last Update Submit

February 23, 2017

Conditions

Keywords

chronic bronchitisemphysemapulmonaryCOPD

Outcome Measures

Primary Outcomes (1)

  • Feasibility of tai chi intervention

    Willingness to participate, adherence, and safety

    12 weeks

Secondary Outcomes (6)

  • Change from baseline- Disease specific quality of life

    baseline, 12 weeks, 24 weeks

  • Change from baseline- Exercise capacity

    baseline, 12 weeks, 24 weeks

  • Change from baseline- Dyspnea

    baseline, 12 weeks, 24 weeks

  • Change from baseline- Psychosocial well-being

    baseline, 12 weeks, 24 weeks

  • Change from baseline- Pulmonary function

    baseline, 12 weeks, 24 weeks

  • +1 more secondary outcomes

Study Arms (3)

tai chi exercise

EXPERIMENTAL
Behavioral: Tai chi

mind-body breathing

EXPERIMENTAL
Behavioral: Mind-body breathing

education

ACTIVE COMPARATOR
Behavioral: Education

Interventions

Tai chiBEHAVIORAL

12 week tai chi class

tai chi exercise

12 week breathing class

mind-body breathing
EducationBEHAVIORAL

12 week education class

education

Eligibility Criteria

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

You may qualify if:

  • Moderate-severe COPD
  • Age ≥ 40 years

You may not qualify if:

  • Subjects with respiratory failure or GOLD stage 4 who are unable to safely perform a 6 minute walk test or otherwise safely exercise as deemed by a physician.
  • COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
  • Planned major pulmonary intervention within the next 3 months
  • Hypoxemia on walk test or cardiopulmonary exercise test
  • Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
  • Clinical signs of unstable cardiovascular disease
  • Severe cognitive dysfunction
  • Non-English speaking
  • Current active participation in pulmonary rehabilitation program or current regular practice of tai chi
  • Physician diagnosis of unstable/untreated clinical depression
  • History of lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Healthcare System

Boston, Massachusetts, 02130, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (4)

  • Kraemer KM, Kilgore K, Litrownik D, Jean-Laurent B, Wayne PM, Richardson CR, Moy ML, Yeh GY. A Web-Based Mind-Body Intervention (Mindful Steps) for Promoting Walking in Chronic Cardiopulmonary Disease: Insights From a Qualitative Study. Glob Adv Integr Med Health. 2023 Dec 2;12:27536130231212169. doi: 10.1177/27536130231212169. eCollection 2023 Jan-Dec.

  • Gilliam EA, Cheung T, Kraemer K, Litrownik D, Wayne PM, Moy ML, Yeh GY. The impact of Tai Chi and mind-body breathing in COPD: Insights from a qualitative sub-study of a randomized controlled trial. PLoS One. 2021 Apr 8;16(4):e0249263. doi: 10.1371/journal.pone.0249263. eCollection 2021.

  • Yeh GY, Litrownik D, Wayne PM, Beach D, Klings ES, Reyes Nieva H, Pinheiro A, Davis RB, Moy ML. BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD. BMJ Open Respir Res. 2020 Nov;7(1):e000697. doi: 10.1136/bmjresp-2020-000697.

  • Yeh GY, Wayne PM, Litrownik D, Roberts DH, Davis RB, Moy ML. Tai chi mind-body exercise in patients with COPD: study protocol for a randomized controlled trial. Trials. 2014 Aug 28;15:337. doi: 10.1186/1745-6215-15-337.

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveBronchitis, ChronicEmphysema

Interventions

Tai JiEducational Status

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBronchitisRespiratory Tract InfectionsInfectionsBronchial Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy ModalitiesSocioeconomic FactorsPopulation Characteristics

Study Officials

  • Gloria Yeh, MD, MPH

    BIDMC, Harvard Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 1, 2012

First Posted

March 13, 2012

Study Start

February 1, 2011

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

February 27, 2017

Record last verified: 2017-02

Locations