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

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

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 Overview

• Status: Unknown
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Other: Yoga

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Principal Investigator: Jennifer Ruddy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Yoga (immediate start) group; This arm will start yoga sessions immediately after screening and will continue sessions for 8 weeks. This group will then continue with home yoga for an additional 8 weeks.	Other: Yoga; Yoga 2 sessions per week for 8 weeks
Active Comparator: Yoga (waitlist) group; This arm will continue regular CF therapies for 8 weeks and will start yoga sessions at week 9.	Other: Yoga; Yoga 2 sessions per week for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
BMI	BMI will be assessed at each study visit.	16 weeks

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Firland Foundation
• Investigators: Principal Investigator: Jennifer Ruddy, MD, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Anticipated): October 1, 2011
• Study Completion (Anticipated): October 1, 2011

Study Registration Dates

• First Submitted: March 16, 2011
• First Submitted That Met QC Criteria: March 28, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): March 30, 2011
• Last Update Submitted That Met QC Criteria: March 28, 2011
• Last Verified: March 1, 2011

More Information

Terms related to this study

• Keywords: Yoga; Cystic Fibrosis
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: 13424