Back to resultsBreath Training Exercise for the Reduction of Chronic Dyspnea
Primary Purpose
Chronic Pulmonary Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
breathing techniques
Self-Administered Baseline and Transition Dyspnea Indexes
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Pulmonary Disorder focused on measuring Dyspnea, Breath Training Exercise, 12-261
Eligibility Criteria
Inclusion Criteria:
- >18 years of age
- Diagnosis of a chronic pulmonary disorder (a diagnosis of lung cancer is not required as the symptom of dyspnea, not cancer itself, is targeted)
- If diagnosed with lung cancer, must have completed definitive treatment more than 6 months prior
- At least moderate dyspnea defined by a BDI score of 6 or less in the Self- Administered Computerized Versions of the Baseline and Transition Dyspnea Indexes(SAC-BDI/TDI)13,14 (This cutoff score is close to the score of 5.7 used to define "moderate dyspnea" in the publication that validated the instrument and is selected by attending physicians in the Pulmonary Service as a good indication of "moderate dyspnea" in clinical practice. A typical person with BDI of 6, for example, would be a 52 year old woman who has to pause when walking because of dyspnea and/or has eliminated doing an activity because of dyspnea).
- Able to safely complete the Six Minute Walk Test (6MWT)15 as per attending physician's clinical judgment.
- Respiratory functions clinically stable for the preceding 3 months and expected to be stable for the next 3 months as determined by project PIs and other Pulmonary Medicine faculty.
Exclusion Criteria:
- Life expectancy less than 6 months
- Any cause of dyspnea that is determined by the investigators as readily reversible by other means (e.g. pleural effusion, pulmonary embolism, acute infection, anemia Hb<9.0, etc.)
- Non-English speaking
Sites / Locations
- Memorial Sloan Kettering Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
The breath training program
Arm Description
Approximately 30-minutes of group instruction session on breathing techniques delivered at a Main Campus outpatient clinic, followed by approximately 15 minutes twice daily home practice for six weeks with weekly telephone coaching. The intervention will conclude at about week 6. Patients will be encouraged to continue the practice, but there will be no further phone calls to remind patients or to confirm their continuing practice.
Outcomes
Primary Outcome Measures
the feasibility
of a breath training program Feasibility is defined by the combination of acceptance rate (number of patients agreeing to participate divided by total number of offered participation), completion rate (percentage of patients completing 75% of practice sessions and providing data on the SAC-BDI/TDI at baseline and 6 weeks) and estimated effect size (20% improvement in SAC-BDI).
Secondary Outcome Measures
Full Information
NCT ID
NCT01831388
First Posted
April 8, 2013
Last Updated
July 13, 2018
Sponsor
Memorial Sloan Kettering Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01831388
Brief Title
Breath Training Exercise for the Reduction of Chronic Dyspnea
Official Title
Breath Training Exercise for the Reduction of Chronic Dyspnea: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to test whether a breath training exercise program may be used to make patients with chronic lung conditions feel less short of breath, whether such a program is well received by patients and whether a future larger study is worthwhile.
The breath training exercise program uses some breathing techniques derived from Yoga practices. They were shown to help patients experiencing shortness of breath feel less short of breath in other settings. Whether the training is beneficial to patients with chronic lung conditions, especially those with a history of cancer affecting their lungs, is not clear. This study would help us answer that question.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pulmonary Disorder
Keywords
Dyspnea, Breath Training Exercise, 12-261
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
The breath training program
Arm Type
Experimental
Arm Description
Approximately 30-minutes of group instruction session on breathing techniques delivered at a Main Campus outpatient clinic, followed by approximately 15 minutes twice daily home practice for six weeks with weekly telephone coaching. The intervention will conclude at about week 6. Patients will be encouraged to continue the practice, but there will be no further phone calls to remind patients or to confirm their continuing practice.
Intervention Type
Other
Intervention Name(s)
breathing techniques
Intervention Description
During all practice sessions, patients are seated in a chair, where they are guided through a set routine of various breathing techniques (detailed in Appendix A). No yoga poses are involved. There is no demand on the patient's physical condition and no risk of injury. The breath training program, with patients seated throughout, includes:
- an initial teaching session (approximately 30-minute) at main campus by an MSKCC Integrative Medicine Service yoga-breathing instructor; - twice daily,breathing exercises (each approximately 15-minute) for 6 weeks practiced by patients at home with supplied recorded audio instructions; - and weekly follow-up phone calls by research staff (+/- 3 days from day 7 of each week) to identify and manage problems and to determine compliance.
Intervention Type
Behavioral
Intervention Name(s)
Self-Administered Baseline and Transition Dyspnea Indexes
Intervention Description
Patients are asked to complete baseline SAC-BDI/TDI questionnaires at the pulmonary clinic. Patients will return to the pulmonary clinic at about week 6 for SAC-BDI/TDI and tests, and to return the diary recording their home exercises. Resting and post-6MWT pulse oximetry, and Hospital Anxiety and Depression Scale (HADS) will be evaluated as well.
Primary Outcome Measure Information:
Title
the feasibility
Description
of a breath training program Feasibility is defined by the combination of acceptance rate (number of patients agreeing to participate divided by total number of offered participation), completion rate (percentage of patients completing 75% of practice sessions and providing data on the SAC-BDI/TDI at baseline and 6 weeks) and estimated effect size (20% improvement in SAC-BDI).
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
>18 years of age
Diagnosis of a chronic pulmonary disorder (a diagnosis of lung cancer is not required as the symptom of dyspnea, not cancer itself, is targeted)
If diagnosed with lung cancer, must have completed definitive treatment more than 6 months prior
At least moderate dyspnea defined by a BDI score of 6 or less in the Self- Administered Computerized Versions of the Baseline and Transition Dyspnea Indexes(SAC-BDI/TDI)13,14 (This cutoff score is close to the score of 5.7 used to define "moderate dyspnea" in the publication that validated the instrument and is selected by attending physicians in the Pulmonary Service as a good indication of "moderate dyspnea" in clinical practice. A typical person with BDI of 6, for example, would be a 52 year old woman who has to pause when walking because of dyspnea and/or has eliminated doing an activity because of dyspnea).
Able to safely complete the Six Minute Walk Test (6MWT)15 as per attending physician's clinical judgment.
Respiratory functions clinically stable for the preceding 3 months and expected to be stable for the next 3 months as determined by project PIs and other Pulmonary Medicine faculty.
Exclusion Criteria:
Life expectancy less than 6 months
Any cause of dyspnea that is determined by the investigators as readily reversible by other means (e.g. pleural effusion, pulmonary embolism, acute infection, anemia Hb<9.0, etc.)
Non-English speaking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary Deng, MD, PhD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mskcc.org/
Description
Memorial Sloan Kettering Cancer Center
Learn more about this trial
Breath Training Exercise for the Reduction of Chronic Dyspnea
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