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

NCT00243282 | Completed

• 2 other identifiers: S05-Shekelle0024PCC 2005-081225
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Complementary Therapies; Dyspnea; Palliative Care; Meditation; Quality of Life

Outcome Measures

Primary Outcomes (1)

• 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

  8 weeks

Secondary Outcomes (1)

• 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

  8 weeks

Study Arms (2)

1

NO INTERVENTION

Control (Support Group)

2

OTHER

Intervention (Mindfulness Based Breathing Therapy)

Behavioral: Relaxation Response (instruction, pocket practice card prov); Behavioral: Mindfulness training using model developed from UMass

Interventions

Relaxation Response (instruction, pocket practice card prov) BEHAVIORAL

2

Mindfulness training using model developed from UMass BEHAVIORAL

2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• Samueli Institute for Information Biology: collaborator

Study Sites (1)

Greater Los Angeles VA Healthcare System

Los Angeles, California, 90073, United States

Location

Related Publications (1)

• 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.

  PMID: 19848546 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Paul G. Shekelle, MD, PhD

  Greater Los Angeles VA Healthcare System, Chief General Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 21, 2005
• Study Start: October 1, 2005
• Study Completion: October 1, 2006
• Last Updated: January 21, 2009

Record last verified: 2008-03

Locations

US (1)