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


N/A
19 Years
N/A
Open (Enrolling)
Both
Chronic Pulmonary Disorder

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

the feasibility

Outcome 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).

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Gary Deng, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-261

NCT ID:

NCT01831388

Start Date:

March 2013

Completion Date:

March 2015

Related Keywords:

  • Chronic Pulmonary Disorder
  • Dyspnea
  • Breath Training Exercise
  • 12-261
  • Dyspnea
  • Lung Diseases

Name

Location

Memorial Sloan-Kettering Cancer Center 1275 York Avenue New York, New York  10021