Ignite Creation Date:
2024-05-05 @ 12:05 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243282
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2005-10-19
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
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 prepost 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
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 prepost 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PCC 2005-081225 | None | None | None |