Randomized Controlled Trial of Mind-Body Breathing Therapy (in Chronic Obstructive Pulmonary Disease) To Improve Palliation of Dyspnea and Health-Related Quality of Life

January 20, 2009 updated by: US Department of Veterans Affairs

Dyspnea (shortness of breath) is a complex experience that includes interpretation of physical impairments and associated distress to the person. The role of mind-body interactions in the experience of the symptom of dyspnea suggests that complementary and alternative medicine (CAM) therapies may be effective in abating dyspnea and improving patients' health-related quality of life. CAM strategies work in a number of ways that are directly applicable to dyspnea, such as decreasing the stress response, inducing relaxation, and facilitating a less distressful interpreted experience of physical disorders.

We have combined a number of established CAM approaches aimed at breath-centered mindfulness and relaxation into an single therapy, mind-body breathing therapy (MBBT). The purpose of this study is to test the efficacy of MBBT in improving dyspnea and health-related quality of life for patients with emphysema (chronic obstructive pulmonary disease).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objectives We aim to test the feasibility and efficacy of mind-body breathing therapy (MBBT) in improving dyspnea and health-related quality of life for patients suffering from late-stage COPD. This randomized controlled trial seeks to assimilate a number of complementary and alternative (CAM) approaches aimed at breath-centered symptom abatement and relaxation into an single therapy and test its efficacy as a palliative care intervention.

Research Plan Patients will be enrolled from outpatient clinics, primarily pulmonary medicine (COPD patients), at the Veteran Affairs (VA) Greater Los Angeles Healthcare System. Patients will be randomized to intervention or control arms. Each arm will include a weekly meeting on the VA campus for 8 successive weeks. Evaluation will include pre/post measurements, serial self-report data, compliance measures, chart abstracted objective data, and follow-up evaluations for 2 months following the intervention or until death. Grant and project will begin in October 2005 and run for one year.

Methods The overall design is a randomized controlled trial of the MBBT intervention on dyspnea symptoms and health-related quality of life (HRQOL). The study will aim to enroll 120 patients over a one year period. We will enroll cognitively intact patients with advanced COPD and dyspnea. Potential subjects will be identified by flyers or provider invitation; screening will ask about enrollment criteria and verified after consent through medical record. Subjects will be recruited through physicians though public advertising and recruitment within the VA will be used to inform patients and physicians of the trial. Patients will be screened at intake during vital signs and offered participation when identified with dyspnea of at least 4 out of 10 points on the Borg Dyspnea Scale. Patients randomized to intervention arm will attend a 8-week session on MBBT that will include a 15 minute video designed by Jon Kabat-Zinn for dyspnea, a relaxation response pocket-guide with group practice and a daily prescription for practice, and weekly mind-body guided sessions for controlled breathing. Control patients will be invited to attend an 8-week session consisting of the a support group with equivalent time and attention as well as identical measures.

Results Primary study outcomes are patients' self report of the severity of dyspnea and HRQOL. Baseline dyspnea will be quantified with the Baseline Dyspnea Index and Borg scale with regular measures of dyspnea using the Visual Analog Scale (VAS). Functional limitation will be measured by the 6-minute walk test and followed with the baseline measure of post-exercise dyspnea level on the Borg scale. Other symptoms will be identified by the Memorial Symptom Assessment Scale (MSAS) and as part of the Saint George Respiratory Questionnaire (SGRQ). HRQOL will be measured by the SGRQ, a 76-item self-administered questionnaire measuring 3 domains (symptoms, activity, and impact of disease on daily life), and in a more general way by the physical health score and mental health score of the Veterans RAND 36 Item Health Survey (VR-36).

Clinical Significance Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death with increasing prevalence throughout the world and within the VA. Dyspnea is among the most troublesome symptoms these patients experience. Mindfulness based meditative strategies has been shown to improve functioning and quality of life, and palliate pain in other populations. However, no trial has specifically evaluated mindful practices or mind-body breathing techniques in the palliation of dyspnea. If shown to be effective, MBBT may represent an important palliative strategy in the management of conditions prevalent in the Veteran population and in medical care in general.

Study Type

Interventional

Enrollment

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90073
        • Greater Los Angeles VA Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic Obstructive Pulmonary Disease
  • Resting Dyspnea > 2 OR Activity Dyspnea > 4 in the prior 4 weeks to screening

Exclusion Criteria:

  • Cognitive impairment on the 10-item Short Portable Mental Status Questionnaire
  • History of serious psychiatric illness
  • Unwilling or unable to participate in the full eight week program and evaluation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Control (Support Group)
Other: 2
Intervention (Mindfulness Based Breathing Therapy)
Behavioral: Relaxation Response (instruction, pocket practice card prov)
Behavioral: Mindfulness training using model developed from UMass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary study outcomes are patients' self report of the severity of dyspnea and HRQOL. Baseline dyspnea will be quantified with the Baseline Dyspnea Index and Borg scale with regular measures of dyspnea using the Visual Analog Scale (VAS). HRQOL will be
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Functional limitation will be measured by the 6-minute walk test and followed with the baseline measure of post-exercise dyspnea level on the Borg scale. Other symptoms will be identified by the Memorial Symptom Assessment Scale (MSAS) and as part of the
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Collaborators

Samueli Institute for Information Biology

Investigators

  • Principal Investigator: Paul G. Shekelle, MD, PhD, Greater Los Angeles VA Healthcare System, Chief General Internal Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Study Completion

October 1, 2006

Study Registration Dates

First Submitted

October 19, 2005

First Submitted That Met QC Criteria

October 19, 2005

First Posted (Estimate)

October 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 21, 2009

Last Update Submitted That Met QC Criteria

January 20, 2009

Last Verified

March 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S05-Shekelle0024
  • PCC 2005-081225

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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