Cystic FibrosisPhase 2NCT01180842
Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With Cystic Fibrosis (CF)
A Phase 2 study testing Yoga treatment program in people with Cystic Fibrosis, run by Children's Hospitals and Clinics of Minnesota at 1 site in United States.
Trial summary
The investigators research question is whether or not yoga effectively alleviates symptoms of pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga does prove to be effective, the investigators will educate our CF population about the benefits they may experience if they choose to… Read more about this study
- Who is it for?
- Ages 9 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Yoga treatment program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Dec 2013
- Phase
- Phase 2
- 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 9 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Positive diagnosis of CF
- Males or females within the ages of 9 and 18
Who cannot join
- No positive diagnosis of CF
- Younger than 9 years of age or older than 18 years of age
- Concomitant illness or disease that may inhibit the patient's ability to participate in the study as determined by the principal investigator
- The patient has participated in an investigational treatment study 30 days prior to pre-session week -2.
- The patient is currently participating in yoga sessions one or more times per week.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55404
About this study
Official title: Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With CF
The investigators research question is whether or not yoga effectively alleviates symptoms of pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga does prove to be effective, the investigators will educate our CF population about the benefits they may experience if they choose to incorporate yoga into their CF therapy. The investigators will also go on to do further research of other complementary alternative medicine therapies.
This is a pre/post-test study with 20 subjects. The subjects will serve as their own controls. Each subject will participate in six yoga sessions over a ten week period. Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is affected by stress. Testing of cortisol throughout the study will help us determine the subjects' stress level throughout the study.
Read the detailed description
H1: The implementation of a yoga therapy program decreases symptoms of pain within our CF population.
H2: The implementation of a yoga therapy program decreases symptoms of sleep disturbance within our CF population.
H3: The implementation of a yoga therapy program decreases symptoms of anxiety within our CF population.
H4: The implementation of a yoga therapy program decreases symptoms of depression within our CF population.
- Conditions
- Cystic Fibrosis
- Being tested
- Yoga treatment program
- Keywords
- CF
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga treatment programOther
yoga program designed specifically for the patient with CF
| Study group | Role | What they receive |
|---|---|---|
| Alternative Treatment | Other | The CF Patient Population receiving the specific yoga study treatment Receives: Other: Yoga treatment program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improve Quality of Life measured through self report questionnaires
Tool: CFQ-R
Measured: We expect this study to last one year.
Secondary outcomes (4)
Reduce symptoms of pain measured through self report questionnaires
Tools: 1) MSAS and 2)Additional Pain Symptoms Questions
Measured: 1 year
Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing
Assessed through 1)Saliva cortisol testing and 2)tools:STAIC and HADS
Measured: 1 year
Reduce symptoms of sleep disturbance measured through self report questionnaires
tools: 1)MSAS and 2)CES-DC
Measured: 1 year
Reduce symptoms of depression measured through self report questionnaires and cortisol testing
tools: 1)CES-DC, 2) HADS and 3) saliva cortisol testing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2013
- Study completionDec 2013
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospitals and Clinics of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John McNamara, MD, Principal investigator, Children's Hospitals and Clinics of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01180842
- Sponsor's protocol ID
- 0911-104
- Status last verified
- Feb 2014
- First submitted
- 25 May 2010
- Last updated
- 14 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Anxiety/Depression and Pain Through Relaxation Yoga for Patient With CF
- ClinicalTrials.gov ID
- NCT01180842
- Acronym / sponsor ID
- 0911-104
- Conditions
- Cystic Fibrosis
- Keywords
- CF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Children's Hospitals and Clinics of MinnesotaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 12 Aug 2010 (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.
The investigators research question is whether or not yoga effectively alleviates symptoms of pain, sleep disturbance, anxiety and depression in children with cystic fibrosis. If yoga does prove to be effective, the investigators will educate our CF population about the benefits they may experience if they choose to incorporate yoga into their CF therapy. The investigators will also go on to do further research of other complementary alternative medicine therapies.
This is a pre/post-test study with 20 subjects. The subjects will serve as their own controls. Each subject will participate in six yoga sessions over a ten week period. Subjects' symptoms will be evaluated with the use of questionnaires. The investigators will also test cortisol levels on weeks -2, -1, 1, 6, 7, 8. Cortisol is a hormone that is affected by stress. Testing of cortisol throughout the study will help us determine the subjects' stress level throughout the study.
Detailed description
H1: The implementation of a yoga therapy program decreases symptoms of pain within our CF population.
H2: The implementation of a yoga therapy program decreases symptoms of sleep disturbance within our CF population.
H3: The implementation of a yoga therapy program decreases symptoms of anxiety within our CF population.
H4: The implementation of a yoga therapy program decreases symptoms of depression within our CF population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Alternative Treatment | Other | Other: Yoga treatment programThe CF Patient Population receiving the specific yoga study treatment |
Who may qualify
- Ages
- 9 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Positive diagnosis of CF
- Males or females within the ages of 9 and 18
Key exclusion criteria (5 listed)
- No positive diagnosis of CF
- Younger than 9 years of age or older than 18 years of age
- Concomitant illness or disease that may inhibit the patient's ability to participate in the study as determined by the principal investigator
- The patient has participated in an investigational treatment study 30 days prior to pre-session week -2.
- The patient is currently participating in yoga sessions one or more times per week.
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 |
|---|---|---|
| Yoga treatment programyoga program designed specifically for the patient with CF | Other | Alternative Treatment |
Primary outcome
Improve Quality of Life measured through self report questionnaires
Time frame: We expect this study to last one year.
Tool: CFQ-R
4 secondary outcomes
Reduce symptoms of pain measured through self report questionnaires
Time frame: 1 year
Reduce symptoms of anxiety measured through self report questionnaires and cortisol testing
Time frame: 1 year
Reduce symptoms of sleep disturbance measured through self report questionnaires
Time frame: 1 year
Reduce symptoms of depression measured through self report questionnaires and cortisol testing
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2014.
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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.
John McNamara, MD principal investigator
Children's Hospitals and Clinics of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yoga treatment program in people with Cystic Fibrosis, run by Children's Hospitals and Clinics of Minnesota 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 14 Feb 2014. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improve Quality of Life measured through self report questionnaires (time frame: We expect this study to last one year.). 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 14 Feb 2014.