search
Back to results

Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial (LEAP)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Group Walking
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic bronchitis, Emphysema, Pulmonary, COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) <0.70 or chest CT evidence of emphysema
  2. Age > 40 years
  3. Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4
  4. Completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry* *Defined as attending 65% of the program's sessions with a minimum of 10 sessions

Exclusion Criteria:

  1. COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
  2. Hypoxemia on walk test (O2 sat < 85% on oxygen)
  3. Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
  4. Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test)
  5. Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24)
  6. Non-English speaking
  7. Current regular practice of tai chi
  8. Current diagnosis of lung cancer or treated for lung cancer within the past 5 years
  9. Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention

Sites / Locations

  • VA Healthcare System
  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Standard Care

Tai Chi Exercise

Group Walking Exercise

Arm Description

No intervention

24 week Tai Chi intervention designed for individuals with COPD

24 week group walking intervention

Outcomes

Primary Outcome Measures

Feasibility of tai chi intervention
Willingness to participate, adherence, and safety

Secondary Outcome Measures

Change from baseline - Disease specific quality of life
Chronic Respiratory Questionnaire
Change from baseline - Exercise capacity
Six minute walk distance
Change from baseline - Dyspnea
University of California, San Diego Shortness of Breath Questionnaire
Change from baseline - Psychosocial well-being
Center for Epidemiologic Studies Depression Scale, Perceived Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Perceived Social Support
Changes from baseline - Pulmonary function
Spirometry
Change from baseline - Exercise Efficacy
Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year

Full Information

First Posted
November 25, 2013
Last Updated
October 2, 2018
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
search

1. Study Identification

Unique Protocol Identification Number
NCT01998724
Brief Title
Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Acronym
LEAP
Official Title
Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic bronchitis, Emphysema, Pulmonary, COPD

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
No intervention
Arm Title
Tai Chi Exercise
Arm Type
Experimental
Arm Description
24 week Tai Chi intervention designed for individuals with COPD
Arm Title
Group Walking Exercise
Arm Type
Experimental
Arm Description
24 week group walking intervention
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
24 week tai chi intervention designed for individuals with COPD
Intervention Type
Behavioral
Intervention Name(s)
Group Walking
Intervention Description
24 week group walking intervention
Primary Outcome Measure Information:
Title
Feasibility of tai chi intervention
Description
Willingness to participate, adherence, and safety
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change from baseline - Disease specific quality of life
Description
Chronic Respiratory Questionnaire
Time Frame
Baseline, 12 weeks, 24 weeks, 1 year
Title
Change from baseline - Exercise capacity
Description
Six minute walk distance
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline - Dyspnea
Description
University of California, San Diego Shortness of Breath Questionnaire
Time Frame
Baseline, 12 weeks, 24 weeks, 1 year
Title
Change from baseline - Psychosocial well-being
Description
Center for Epidemiologic Studies Depression Scale, Perceived Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Perceived Social Support
Time Frame
Baseline, 12 weeks, 24 weeks, 1 year
Title
Changes from baseline - Pulmonary function
Description
Spirometry
Time Frame
Baseline, 12 weeks, 24 weeks
Title
Change from baseline - Exercise Efficacy
Description
Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year
Time Frame
Throughout study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) <0.70 or chest CT evidence of emphysema Age > 40 years Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4 Completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry* *Defined as attending 65% of the program's sessions with a minimum of 10 sessions Exclusion Criteria: COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline Hypoxemia on walk test (O2 sat < 85% on oxygen) Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test) Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24) Non-English speaking Current regular practice of tai chi Current diagnosis of lung cancer or treated for lung cancer within the past 5 years Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gloria Yeh, MD, MPH
Organizational Affiliation
BIDMC, Harvard Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34023739
Citation
Gilliam EA, Kilgore KL, Liu Y, Bernier L, Criscitiello S, Litrownik D, Wayne PM, Moy ML, Yeh GY. Managing the experience of breathlessness with Tai Chi: A qualitative analysis from a randomized controlled trial in COPD. Respir Med. 2021 Aug;184:106463. doi: 10.1016/j.rmed.2021.106463. Epub 2021 May 15.
Results Reference
derived
PubMed Identifier
26362690
Citation
Moy ML, Wayne PM, Litrownik D, Beach D, Klings ES, Davis RB, Yeh GY. Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi. Contemp Clin Trials. 2015 Nov;45(Pt B):458-467. doi: 10.1016/j.cct.2015.09.004. Epub 2015 Sep 8.
Results Reference
derived

Learn more about this trial

Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial

We'll reach out to this number within 24 hrs