Randomized Controlled Trial of Mind-Body Breathing Therapy (in Chronic Obstructive Pulmonary Disease) To Improve Palliation of Dyspnea and Health-Related Quality of Life
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Relaxation Response (instruction, pocket practice card prov)
Mindfulness training using model developed from UMass
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Complementary Therapies, Dyspnea, Palliative Care, Meditation, Quality of Life
Eligibility Criteria
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
Sites / Locations
- Greater Los Angeles VA Healthcare System
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Other
Arm Label
1
2
Arm Description
Control (Support Group)
Intervention (Mindfulness Based Breathing Therapy)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00243282
First Posted
October 19, 2005
Last Updated
January 20, 2009
Sponsor
US Department of Veterans Affairs
Collaborators
Samueli Institute for Information Biology
1. Study Identification
Unique Protocol Identification Number
NCT00243282
Brief Title
Randomized Controlled Trial of Mind-Body Breathing Therapy (in Chronic Obstructive Pulmonary Disease) To Improve Palliation of Dyspnea and Health-Related Quality of Life
Official Title
Randomized Controlled Trial of Mind-Body Breathing Therapy (in Chronic Obstructive Pulmonary Disease) To Improve Palliation of Dyspnea and Health-Related Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
US Department of Veterans Affairs
Collaborators
Samueli Institute for Information Biology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Complementary Therapies, Dyspnea, Palliative Care, Meditation, Quality of Life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Description
Control (Support Group)
Arm Title
2
Arm Type
Other
Arm Description
Intervention (Mindfulness Based Breathing Therapy)
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Response (instruction, pocket practice card prov)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness training using model developed from UMass
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G. Shekelle, MD, PhD
Organizational Affiliation
Greater Los Angeles VA Healthcare System, Chief General Internal Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Greater Los Angeles VA Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
19848546
Citation
Mularski RA, Munjas BA, Lorenz KA, Sun S, Robertson SJ, Schmelzer W, Kim AC, Shekelle PG. Randomized controlled trial of mindfulness-based therapy for dyspnea in chronic obstructive lung disease. J Altern Complement Med. 2009 Oct;15(10):1083-90. doi: 10.1089/acm.2009.0037.
Results Reference
derived
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Randomized Controlled Trial of Mind-Body Breathing Therapy (in Chronic Obstructive Pulmonary Disease) To Improve Palliation of Dyspnea and Health-Related Quality of Life
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