Breath Training Exercise for the Reduction of Chronic Dyspnea

Chronic Pulmonary Disorder Clinical Trial

Official title:

Breath Training Exercise for the Reduction of Chronic Dyspnea: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01831388
• Other study ID #: 12-261
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: July 2018

Study information

• Verified date: July 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pulmonary Disorder
• Dyspnea
• Lung Diseases

Intervention

Other:
• breathing techniques
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.

Behavioral:
• Self-Administered Baseline and Transition Dyspnea Indexes
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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	2 years

External Links

•   Memorial Sloan Kettering Cancer Center