ACTRN12609000535279Recruiting未知
The effect of an integrated yoga intervention on sleep quality and overall quality of life in an elderly Australian population with insomnia.
Royal Melbourne Institute of Technology (RMIT) University0 sites120 target enrollmentStarted: July 3, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 60 Years to o limit (—)
- Sex
- All
Inclusion Criteria
- •Individuals aged 60 and above who are sedentary (structured exercise < once/week); sleep complaints of at least 3 times a week for at least 1 month (Diagnostic and Statistical Manual IV(DSM-IV) classification with a Pittsburgh Sleep Quality Index (PSQI) score of > 5 currently; willingness to accept random assignment and comply with study protocols.
Exclusion Criteria
- •Failure to keep a two-week sleep log during the run-in period; Evidence of primary sleep disorders (sleep apnoea, restless leg syndrome, periodic leg movement) by history or polysomnography, myocardial infarction (within 6 months), unstable medical conditions (e.g. diabetes, hypertension or ischaemic heart disease); Peri-menopausal women with symptoms of hot flushes and/or night sweats; Major mental illness or dementia by DSM-IV criteria or Geriatric Depression Scale (GDS) score > 13 (range 0-30); Use of sedative-hypnotic / non-prescription sleep medications / antidepressants in the last month; Alcohol intake greater than 20 grams (2 drinks) per day on average; planned life stressors (moving, divorce, etc.), shift work, or transcontinental travel; medical causes of insomnia, Congestive Health Failure (CHF), nocturia, Benign Prostatic Hyperplasia (BPH), diabetic neuropathy, musculoskeletal pain from arthritis or other cause, restless bed partner, medications disrupting sleep, or an unwillingness or inability to give consent.
Investigators
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