Breath Training Exercise for the Reduction of Chronic Dyspnea

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.

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Key information

Conditions

Chronic Pulmonary Disorder Dyspnea Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

breathing techniques

Other

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.

Self-Administered Baseline and Transition Dyspnea Indexes

Behavioral

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 outcomes

the feasibility

Time frame: 2 years

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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2018
Study completion: 2018
First posted: Apr 15, 2013
Registry last updated: Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed