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

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ClinicalTrials.gov Identifier: NCT01325766
Recruitment Status : Unknown
Verified March 2011 by Seattle Children's Hospital.
Recruitment status was:  Recruiting
First Posted : March 30, 2011
Last Update Posted : March 30, 2011
Sponsor:
Collaborator:
Firland Foundation
Information provided by:
Seattle Children's Hospital

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Other: Yoga Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Yoga as a Therapy for Adolescents and Young Adults With Cystic Fibrosis: A Pilot Study
Study Start Date : February 2011
Estimated Primary Completion Date : October 2011
Estimated Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cystic Fibrosis

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




Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 16 weeks ]
    Determine if a yoga program is safe for CF patients by monitoring for adverse events throughout the study.

  2. Pain Scores on the Visual Analog Scale as a measure of tolerability [ Time Frame: 16 weeks ]
    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.


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 16 weeks ]
    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.

  2. Respiratory symptoms [ Time Frame: 16 weeks ]
    This will be assessed using a cystic fibrosis respiratory symptom diary that will taken once per week at home throughout the study.

  3. Treatment adherence [ Time Frame: 16 weeks ]
    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.

  4. Pulmonary function [ Time Frame: 16 weeks ]
    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.

  5. Ease of breathing [ Time Frame: 16 weeks ]
    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.

  6. BMI [ Time Frame: 16 weeks ]
    BMI will be assessed at each study visit.



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01325766


Contacts
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Contact: Sharon McNamara 206-987-3921 sharon.mcnamara@seattlechildrens.org

Locations
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United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact: Sharon McNamara    206-987-3921    sharon.mcnamara@seattlechildrens.org   
Principal Investigator: Jennifer Ruddy, MD         
Sponsors and Collaborators
Seattle Children's Hospital
Firland Foundation
Investigators
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Principal Investigator: Jennifer Ruddy, MD Seattle Children's Hospital
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Responsible Party: Jennifer Ruddy MD, Seattle Children's Hospital, University of Washington Medical Center
ClinicalTrials.gov Identifier: NCT01325766    
Other Study ID Numbers: 13424
First Posted: March 30, 2011    Key Record Dates
Last Update Posted: March 30, 2011
Last Verified: March 2011
Keywords provided by Seattle Children's Hospital:
Cystic Fibrosis
Yoga
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases