Cystic FibrosisNCT01325766
Study of Yoga as a Therapy for Cystic Fibrosis (CF) Patients
A study testing Yoga in people with Cystic Fibrosis, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 25 years
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Yoga
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Sharon McNamara, 206-987-3921, sharon.mcnamara@seattlechildrens.org
Jennifer Ruddy, MD
About this study
Official title: 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.
- Conditions
- Cystic Fibrosis
- Being tested
- Yoga
- Keywords
- Cystic Fibrosis, Yoga
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaOther
Yoga 2 sessions per week for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Yoga (immediate start) group | Active comparator | 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. Receives: Other: Yoga |
| Yoga (waitlist) group | Active comparator | This arm will continue regular CF therapies for 8 weeks and will start yoga sessions at week 9. Receives: Other: Yoga |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 weeks
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 16 weeks
BMI
BMI will be assessed at each study visit.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Firland Foundation
- Investigators
- Jennifer Ruddy, MD, Principal investigator, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01325766
- Sponsor's protocol ID
- 13424
- Status last verified
- Mar 2011
- First submitted
- 16 Mar 2011
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga as a Therapy for Adolescents and Young Adults With Cystic Fibrosis: A Pilot Study
- ClinicalTrials.gov ID
- NCT01325766
- Acronym / sponsor ID
- 13424
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Yoga
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Firland Foundation
- Study start
- Feb 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 30 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga (immediate start) group | Active comparator | Other: YogaThis 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. |
| Yoga (waitlist) group | Active comparator | Other: YogaThis arm will continue regular CF therapies for 8 weeks and will start yoga sessions at week 9. |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YogaYoga 2 sessions per week for 8 weeks | Other | Yoga (immediate start) group, Yoga (waitlist) group |
Primary outcome
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.
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.
6 secondary outcomes
Quality of Life
Time frame: 16 weeks
Respiratory symptoms
Time frame: 16 weeks
Treatment adherence
Time frame: 16 weeks
Pulmonary function
Time frame: 16 weeks
Ease of breathing
Time frame: 16 weeks
BMI
Time frame: 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Ruddy, MD principal investigator
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Cystic Fibrosis, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon McNamara (206-987-3921, sharon.mcnamara@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety (time frame: 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2011.