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

NCT ID: NCT01325766

Last Updated: 2011-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cystic Fibrosis

Keywords

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Cystic Fibrosis Yoga

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Yoga

Intervention Type OTHER

Yoga 2 sessions per week for 8 weeks

Yoga (waitlist) group

This arm will continue regular CF therapies for 8 weeks and will start yoga sessions at week 9.

Group Type ACTIVE_COMPARATOR

Yoga

Intervention Type OTHER

Yoga 2 sessions per week for 8 weeks

Interventions

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Yoga

Yoga 2 sessions per week for 8 weeks

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Firland Foundation

UNKNOWN

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seattle Children's Hospital, University of Washington Medical Center

Principal Investigators

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Jennifer Ruddy, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sharon McNamara

Role: CONTACT

Phone: 206-987-3921

Email: [email protected]

Facility Contacts

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Sharon McNamara

Role: primary

Other Identifiers

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13424

Identifier Type: -

Identifier Source: org_study_id