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Breath Training Exercise for the Reduction of Chronic Dyspnea

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01831388
First received: April 8, 2013
Last updated: August 12, 2014
Last verified: August 2014

April 8, 2013
August 12, 2014
March 2013
March 2015   (final data collection date for primary outcome measure)
the feasibility [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01831388 on ClinicalTrials.gov Archive Site
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Breath Training Exercise for the Reduction of Chronic Dyspnea
Breath Training Exercise for the Reduction of Chronic Dyspnea: a Pilot Study

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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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Chronic Pulmonary Disorder
  • 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 our 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 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.
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.
Interventions:
  • Other: breathing techniques
  • Behavioral: Self-Administered Baseline and Transition Dyspnea Indexes
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
March 2015
March 2015   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact: Gary Deng, MD PhD 646-888-0841
Contact: Marc Feinstein, MD 212-639-8552
United States
 
NCT01831388
12-261
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Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Gary Deng, MD, PhD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP