View Clinical Trial (Medical Research Study)
Yoga as a Therapy for Adolescents and Young Adults With Cystic Fibrosis: A Pilot Study
| City: |
|
Seattle |
| State: |
|
Washington |
| Zip Code: |
|
98105 |
| Conditions: |
|
Cystic Fibrosis |
| Purpose: |
|
Cystic fibrosis (CF) is a lung disease that affects 30,000 children and adults in the US.
Incorporation of regular exercise into the lives of patients with CF is of interest because
it may improve lung function and quality of life. Yoga is an activity that may benefit
patients with CF in many ways including strengthening muscles of breathing, improving lung
function, and reducing stress which could improve quality of life and adherence to
therapies. Yoga has been shown to be beneficial in patients with other lung diseases such
as asthma, but has not yet been studied in CF.
The investigators hypothesize that yoga will be an activity that is safe and tolerable for
CF patients 12 to 25 years of age. The primary aim is to investigate the safety and
tolerability of an 8 week yoga program for patients with CF. The secondary aim is to
determine the effect of yoga on many aspects of CF disease including respiratory symptoms,
adherence to regular CF therapies, quality of life, lung function, exercise tolerance, and
nutritional status.
The long-term goal is to use the data obtained in this study to design a future study of the
efficacy of yoga in a larger population of CF patients at multiple CF centers. This
research has the potential to influence the prevention and treatment of CF by providing data
which could be used to help understand the most appropriate and beneficial type of physical
activity for CF patients.
|
| Study Summary: |
|
|
| Criteria: |
|
Inclusion Criteria:
o Diagnosis of CF by: Sweat chloride ≥60meq/L on two occasions or CFTR genotype with two
CF disease-causing mutations and one or more phenotypic features of CF
- Age ≥12 and ≤25 years
- FEV1 ≥40 % predicted at screening visit
- Informed consent and assent
Exclusion Criteria:
- Wheezing on auscultation of the chest at the enrollment visit
- Oxygen saturation < 90 % at the enrollment visit
- Initiation of treatment with oral, inhaled or intravenous antibiotics for an acute
respiratory infection in the 2 weeks preceding the enrollment visit
- Pregnancy
- History of lung transplant
- Practiced yoga regularly (≥1 time per week) in the month prior to enrollment
- Current enrollment in a therapeutic clinical trial
- Condition or situation which, in the opinion of the investigator, would affect the
ability of the patient or family to complete study procedures
|
| NCT ID: |
|
NCT01325766 |
| Primary Contact: |
|
Principal Investigator
Jennifer Ruddy, MD
Seattle Children's Hospital
Sharon McNamara
Phone: 206-987-3921
Email: sharon.mcnamara@seattlechildrens.org
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Seattle, Washington 98105
United States
Sharon McNamara
Phone: 206-987-3921
Email: sharon.mcnamara@seattlechildrens.org
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|