Study of Yoga as a Therapy for Cystic Fibrosis (CF) Patients

Cystic Fibrosis Clinical Trial

Official title:

Yoga as a Therapy for Adolescents and Young Adults With Cystic Fibrosis: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01325766
• Other study ID #: 13424
• Status: Recruiting
• Phase: N/A
• First received: March 16, 2011
• Last updated: March 28, 2011
• Start date: February 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2011
• Source: Seattle Children's Hospital
• Contact: Sharon McNamara
• Phone: 206-987-3921
• Email: sharon.mcnamara[@]seattlechildrens.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 25 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• Yoga
Yoga 2 sessions per week for 8 weeks

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Firland Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Adverse Events as a Measure of Safety	Determine if a yoga program is safe for CF patients by monitoring for adverse events throughout the study.	16 weeks	Yes
Primary	Pain Scores on the Visual Analog Scale as a measure of tolerability	Participants will be given a tolerance questionnaire after each yoga session which will assess their degree of musculoskeletal and chest pain on a visual analog scale. Vital signs will also be measured before and after each yoga session.	16 weeks	No
Secondary	Quality of Life	This will be assessed with the Cystic fibrosis quality of life questionnaire-revised. This is a CF specific quality of life outcome measure and will be administered at each study visit.	16 weeks	No
Secondary	Respiratory symptoms	This will be assessed using a cystic fibrosis respiratory symptom diary that will taken once per week at home throughout the study.	16 weeks	No
Secondary	Treatment adherence	This will be assessed by participants taking a treatment adherence questionnaire once per week at home. Questions are asked regarding compliance with other CF therapies.	16 weeks	No
Secondary	Pulmonary function	Pulmonary function will be monitored by spirometry at the screening visit and at both study visits. Participants will be assessed for response to bronchodilator at the screening visit. If there is a positive response, post-bronchodilator testing will be done again at the last study visit.	16 weeks	No
Secondary	Ease of breathing	This will be assessed by the ease of breathing score which is a measure of shortness of breath after activity. This will be done at screening and at each study visit.	16 weeks	No
Secondary	BMI	BMI will be assessed at each study visit.	16 weeks	No