A Phase 2 interventional study of Yoga treatment program in Cystic Fibrosis, sponsored by Children's Hospitals and Clinics of Minnesota. Completed at 1 site in United States. Open to participants aged 9 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-02-14.
Sponsored by Children's Hospitals and Clinics of Minnesota · Phase 2, Interventional, and Treatment
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.
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 20 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Children's Hospitals and Clinics of Minnesota is the lead sponsor of 49 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The CF Patient Population receiving the specific yoga study treatment
Other: Yoga treatment program
yoga program designed specifically for the patient with CF
Improve Quality of Life measured through self report questionnaires
Tool: CFQ-R
Time frame: We expect this study to last one year.
Reduce symptoms of pain measured through self report questionnaires
Tools: 1) MSAS and 2)Additional Pain Symptoms Questions
Time frame: 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
Time frame: 1 year
Reduce symptoms of sleep disturbance measured through self report questionnaires
tools: 1)MSAS and 2)CES-DC
Time frame: 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
Time frame: 1 year
This study is completed, as verified in Feb 2014. You cannot join it, but the record below documents what was studied.
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Children's Hospitals and Clinics of Minnesota