Yoga for Treatment of Hot Flashes
| Tracking Information | |||||
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| First Received Date ICMJE | January 25, 2006 | ||||
| Last Updated Date | January 25, 2006 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Reduction of number and severity of hot flashes will be summarized by the sample averages. | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Yoga for Treatment of Hot Flashes | ||||
| Official Title ICMJE | Yoga for Treatment of Hot Flashes and Menopausal Symptoms | ||||
| Brief Summary | The Yoga for Treatment of Hot Flashes and Menopausal Symptoms is an uncontrolled pilot clinical trial to determine the feasibility of recruitment and of evaluating yoga for the relief of menopausal hot flashes in 12 peri- or postmenopausal women. Participants will attend an Introductory Yoga Workshop, 8 yoga training sessions in 8 weeks, be assessed clinically before, during, and after training and contacted by telephone 3 months later. |
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| Detailed Description | This is an uncontrolled pilot trial of yoga among 12 healthy peri- or postmenopausal women experiencing at least 4 hot flashes per day or 30 hot flashes per week. Participants will complete a Screening and Baseline Visit, and then be taught yoga during weekly sessions that will be held in the evening at the Laurel Heights Conference Center. The yoga postures and breathing techniques will be taught by a qualified and certified yoga instructor using the standardized protocol determined by a Yoga Expert Panel. Each group yoga session will take approximately 90 minutes. Participants will also be required to practice yoga at home at least 3 times per week, and be given yoga materials (mat, blocks, straps), and an instruction manual for their use at home. They will be asked to keep a calendar log of the dates/times that they practiced yoga at home. Outcomes will be assessed midway through the yoga training and at a Final Visit. The main efficacy outcomes are change in number of hot flashes per week and change in severity of hot flashes from baseline to post-training reported on a 7-day diary. We will also measure changes in sleep and quality of life. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Menopause-Related Hot Flashes | ||||
| Intervention ICMJE | Behavioral: Yoga | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 12 | ||||
| Completion Date | December 2005 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Not Provided | ||||
| Ages | 40 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00283205 | ||||
| Other Study ID Numbers ICMJE | H5287-26599 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | March 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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