Clinical trial NCT01325766: Study of Yoga as a Therapy for Cystic Fibrosis (CF) Patients
Official title: Yoga as a Therapy for Adolescents and Young Adults With Cystic Fibrosis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis
Yoga
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Firland Foundation
First posted: 2011-03-30
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety
timeFrame: 16 weeks
measure: Pain Scores on the Visual Analog Scale as a measure of tolerability
timeFrame: 16 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 16 weeks
measure: Respiratory symptoms
timeFrame: 16 weeks
measure: Treatment adherence
timeFrame: 16 weeks
measure: Pulmonary function
timeFrame: 16 weeks
measure: Ease of breathing
timeFrame: 16 weeks
measure: BMI
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
Study officials:
affiliation: Seattle Children's Hospital
name: Jennifer Ruddy, MD
role: PRINCIPAL_INVESTIGATOR
References: