Recruiting

Yoga

Sponsor:

Seattle Children's Hospital

Code:

NCT01325766

Conditions

Cystic Fibrosis

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Interventions

Yoga

Study Details

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.

Conditions

Cystic Fibrosis

Study ID

NCT01325766

Start date

Feb, 2011

Status verified date

Mar, 2011

Completion date

Oct, 2011

Anticipated

Primary completion date

Oct, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Interventions and Outcome Measures

Arms

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.

active comparator: Yoga (waitlist) group

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

Interventions

Yoga

Yoga 2 sessions per week for 8 weeks

Primary outcome measure

  • Number of Participants with Adverse Events as a Measure of Safety [ Time Frame: 16 weeks ]
  • Pain Scores on the Visual Analog Scale as a measure of tolerability [ Time Frame: 16 weeks ]

Central Contacts and Locations

Central contacts

Sharon McNamara

206-987-3921sharon.mcnamara@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Sharon McNamara

206-987-3921sharon.mcnamara@seattlechildrens.org

Principal Investigator:

Jennifer Ruddy, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Mar 30, 2011

Last verified

Mar, 2011

Keywords

  • Cystic Fibrosis
  • Yoga

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2011-03-30.