Breath Training Exercise for the Reduction of Chronic Dyspnea
|ClinicalTrials.gov Identifier: NCT01831388|
Recruitment Status : Active, not recruiting
First Posted : April 15, 2013
Last Update Posted : May 3, 2017
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.
|Condition or disease||Intervention/treatment|
|Chronic Pulmonary Disorder||Other: breathing techniques Behavioral: Self-Administered Baseline and Transition Dyspnea Indexes|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Breath Training Exercise for the Reduction of Chronic Dyspnea: a Pilot Study|
|Actual Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Experimental: The breath training program
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.
Other: breathing techniques
Behavioral: Self-Administered Baseline and Transition Dyspnea Indexes
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.
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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01831388
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Gary Deng, MD, PhD||Memorial Sloan Kettering Cancer Center|