Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000535279
Ethics application status
Not yet submitted
Date submitted
13/03/2009
Date registered
3/07/2009
Date last updated
6/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Regular Exercise and Sleep Trial
Scientific title
The effect of an integrated yoga intervention on sleep quality and overall quality of life in an elderly Australian population with insomnia.
Universal Trial Number (UTN)
Trial acronym
REST
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Insomnia 4475 0
Condition category
Condition code
Alternative and Complementary Medicine 4748 4748 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The active intervention will involve two 60 minute yoga classes per week for 3 months by a qualified yoga teacher. Participants will be given a choice of at least five classes (daytime, evening and weekend) and each class will be limited to 20 participants to allow the teachers to give personal attention to each participant. Classes will include breathing exercises, relaxation exercises and meditation exercises. Each class will involve yoga postures, include standing poses chosen specifically to incorporate weight bearing and gentle aerobic conditioning elements to help improve and maintain skeletal health, improve balance and coordination to help prevent accidents and falls and improve cardiovascular fitness as well as prone and supine stomach and back exercises chosen specifically to strengthen abdominal and back postural muscles to improve and maintain spinal health. Each class will also incorporate breathing exercises chosen specifically to relax the sympathetic nervous system and enhance parasympathetic activity as well as Yoga Nidra ('sleeping yoga') progressive relaxation exercises to promote deeper relaxation of the whole body and train the relaxation response along with a period of yogic meditation aimed at creating a deeper state of calmness. These elements have been adapted and extended from the 2 published trials of yoga and sleep
Classes will be highly structured and standardised so that a number of different yoga teachers are able to facilitate classes. All poses will include variations to suit individual limitations or preference so they can be practiced with ease and no evidence of strain. A class length of 60 minutes is used for many strengthening and other programs for the elderly. The yoga protocol is not vigorous and includes time spent in physical activity, relaxation and regulated breathing. Participants will be given a CD which will include instructions about exercises to be practised at home at least four times per week.
Intervention code [1] 4218 0
Lifestyle
Intervention code [2] 236849 0
Treatment: Other
Comparator / control treatment
The Control group will have two 60 minute gentle stretching and callisthenics classes per week for 3 months. The yoga instructor will also conduct the control group exercises. Participants will be given a choice of at least five classes (daytime, evening and weekend) and each class will be limited to 20 participants to allow the teachers to give personal attention to each participant. This routine has been successfully used in a variety of randomised control trials led by Professor Fiatorone-Singh [1, 2], and has been shown not to significantly alter physical or psychological outcomes in older adults. Participants will be given a CD which will include instructions about exercises to be practised at home at least four times per week. This intervention will enable double-blinding of all outcomes (subjects are blinded as to the investigators' hypothesis) and equalizes attention and contact time between groups.

References
1. Pu, C., Johnson, MT., Forman, DE., Hausdorff, JM., Roubenoff, R., Foldvari, M., Fielding, RA., Fiatarone Singh, MA., Randomized trial of progressive resistance training to counteract the myopathy of chronic heart failure J Appl Physiol 2001. 90: p. 2341-2350.
2. Singh, N., Clements, KM, Fiatarone Singh, MA., Exercise as a longterm antidepressant: A randomized controlled trial. J of Gerontol (Med Sci), 2001. 56A(6): p. M497-M504.
Control group
Placebo

Outcomes
Primary outcome [1] 5614 0
The Pittsburgh (PSQI) is a self-rated questionnaire that assesses sleep quality over a one-month time interval. There are 19 individual items, which generate seven component scores (sleep quality, use of sleep medications, sleep duration, habitual sleep efficiency, sleep disturbance, and daytime dysfunction) to give a total score reflecting sleep quality (0-21), higher scores reflecting worse sleep quality. It is a valid, sensitive and specific measure of sleep quality in the elderly
Timepoint [1] 5614 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Primary outcome [2] 238258 0
The Insomnia Severity Index (ISI) is a 7 item questionnaire in which participants? perception of the severity of their insomnia is assessed. The items generally match criteria in the DSM-IV-TR and include severity of sleep onset difficulties, sleep maintenance and early morning awakenings, satisfaction with current sleep patterns, interference with daily dysfunction and the degree of worry or distress.
Timepoint [2] 238258 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Primary outcome [3] 238259 0
The Epworth Sleepiness Scale (ESS) is a is a self-administered eight-item questionnaire that measures daytime sleepiness in adults in real life situations that adults engage in, or could imagine themselves in such as sitting down and reading, in a car stopped in traffic or in conversation.
Timepoint [3] 238259 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Primary outcome [4] 238261 0
The Fatigue Severity Scale (FFS) of Sleep Disorders is a 9 item self-report questionnaire which asks the user to rate whether they agree or disagree (on a 7 point likert scale) with statements regarding their level of fatigue over the past week. The scale is used to rate the severity of fatigue symptoms.
Timepoint [4] 238261 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Primary outcome [5] 238262 0
The daily sleep log completed upon waking documents the sleep-onset latency (time taken to fall asleep, recorded to nearest 5 min), total sleep time (h/min, recorded to nearest 15 min), frequency of awakenings (total across night), time taken to return to sleep (to nearest 5 min), and wake time after sleep-onset (to nearest 5 min). Sleep efficiency (%) is calculated as (total sleep time/total time in bed) * 100. Sleep logs represent an accurate portrayal of the sleep of insomnia patients.
Timepoint [5] 238262 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Secondary outcome [1] 9452 0
Objective Sleep Quality Sleep. electroencephalogram (EEG), electroocculogram (EOG) and electromyogram (EMG) will be monitored to stage sleep states, measure Sleep Onset Latencies (SOL - the time from lights out to the start of the first three consecutive sleep epochs) and score arousals from sleep. Calculated variables to be used in analyses include: Total wake time (the total time of awake epochs within the Sleep period), SOL, and Sleep efficiency, to allow comparisons with subjective measures of these clinically relevant sleep indices. The sleep studies will be performed beginning 48 hours after the last Yoga session and participants will be asked not to engage in any other forms of exercise in this time. Subjects will be asked to refrain from alcohol, caffeine, nicotine for four hours prior to bed and during the night of monitoring. The S-series Sleep System, (Compumedics, Australia) will be used for this study. The reliability of the sleep measures is based on the reliable recording of EEG with accurate measurement of the skull according to the international 10-20 electrode placement system, and accurate scoring of sleep staging. We use strict EEG scoring guidelines. The staging is performed manually on an epoch-by-epoch (30s-screen epoch) basis. For EEG arousal scoring, the guidelines of the American Sleep Disorders Association (ASDA 1992) will be used. The calculated coefficient of variation of repeated analyses of sleep outcomes in our laboratory averages 2.24% (range 0.0-8.3%).
Timepoint [1] 9452 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Secondary outcome [2] 244623 0
Quality of Life. This will be evaluated by the Medical Outcome Survey (SF-36), which is a 36-item measure of health-related quality of life, comprised of 8 sub-scales, including Vitality, which is relevant to the effects of sleep quality on daytime fatigue. It is a reliable and valid measure in the community-dwelling elderly with published norms for Australian healthy and clinical populations.
Timepoint [2] 244623 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Secondary outcome [3] 244624 0
Mood, Anxiety, Arousal and Symptoms of Psychopathology. Mood will be measured by the Profile of Mood States (POMS). The POMS consists of 65 adjectives describing mood status. Responses are constrained to 1 of 5 possibilities ranging from "not at all" to "extremely." The questionnaire is administered and scored by a technician and can be completed in 5 to 10 minutes. This is a reliable and valid instrument describing transient feelings rather than personality traits occurring "during the past week, including today" with different time specifications. Symptoms of psychopathology will be assessed using the Hospital Anxiety and Depression Scale (HADS). The Hospital Anxiety and Depression Scale is designed for use in hospitals or outpatient settings. It is a 14 item questionnaire designed to assess symptoms of anxiety and depression. Specific Anxiety will be measured using the Anxiety and Preoccupation about Sleep Questionnaire (APSQ). The APSQ 10-point scale that assesses how true each statement is for them over the past three days (1 ?not true?, 10 ?very true?). The reliability and validity of the questionnaire has been established. Arousal will be measured using the Pre-sleep Arousal Scale (PSAS) is a valid and reliable measure which comprises 16 items rated on a 5-point scale (1 = not at all to 5 = extremely). Eight of the items measure somatic arousal (e.g., ?cold feeling in your hands, feet or your body in general?), and the other half measure cognitive arousal (e.g., ?worry about falling asleep?)
Timepoint [3] 244624 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Secondary outcome [4] 244625 0
Mindfulness and Monitoring. Mindfulness will be measured using the Five Facet Mindfulness Questionnaire (FFMQ) [6], which is a 39-item self-report instrument that is based on a factor analytic study of five independently developed mindfulness questionnaires. The analysis yielded five factors that appear to represent elements of mindfulness conceptualized as skills, which are: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Monitoring is measured by the Sleep Associated Monitoring Index (SAMI). The SAMI is a 32 item self report questionnaire, measured on a 5 point scale which participants indicate what is true for them over the past month (1 ?not at all?, 5 ?all the time?). This test is considered a reliable and valid instrument to index monitoring for sleep-related threat.
Timepoint [4] 244625 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Secondary outcome [5] 244626 0
Cognitive Function Participants? cognitive function will be assessed using 4 subtests from the Neuropsychological Assessment Battery (NAB). The NAB is a comprehensive, integrated, modular battery of 33 new neuropsychological tests developed to assess a wide array of neuropsychological skills and functions in adults (ages 18-97 years). Four subtests have been selected to measure attention and working memory (Digits Backward), memory (Story Learning, Daily Living Memory) and executive functioning (Word Generation). This test battery has been well validated, and has alternate forms for time-points.
Timepoint [5] 244626 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).
Secondary outcome [6] 244627 0
Adverse events and Health Resource Utilization: All adverse events and health resource utilisation will be recorded as part of the weekly compliance logs, to reduce loss of data related to memory for remote events.
Timepoint [6] 244627 0
Baseline and 12 weeks following the commencement of the treatment program and 64 weeks (12 months post intervention).

Eligibility
Key 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.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Subjects will be screened in a three-part process, as detailed below.
1. Participants will be recruited via advertising. Interested participants will phone the researchers, who will explain the study to them. If the person is still interested in participating, the researcher will then assess overall eligibility for the study by administering a brief telephone questionnaire to ensure inclusion criteria including the presence of insomnia and ability to comply with physical requirements of the protocol. The telephone screen will provisionally assess exclusion criteria such as major mental or physical illness and current medication. If they are eligible and willing to comply with the protocol, include random allocation to one of the treatment groups, they will be booked in for an initial consultation – and written information (the PICF) will be posted out to the participant.
2. At the Screening Visit, eligible participants will sign the patient information and informed consent (PICF) if they feel able to meet the requirements of the study. Further screening at this visit will entail: measurement of height and weight, medical history and completion of the Pittsburgh Sleep Quality Index (PSQI). Volunteers identified to have major depression or suicidality will be referred to their local General Practitioner for follow up and will not be eligible for the trial.
3. Volunteers who remain eligible after this screening period will be scheduled to have a sleep study (PSG) to screen for primary sleep disorders and will be required to stay over night in the sleep laboratory. For this overnight Sleep Study baseline visit, participants will be mailed out a battery of tests including the following questionnaires: Profile of Mood States (POMS), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), SF-36 Health Survey, Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), Physical Activity Scale for Elderly (PASE), Fatigue Severity Scale (FSS), Five Facet Mindfulness Questionnaire (FFMQ), Anxiety and Preoccupation about Sleep Questionnaire (APSQ), Sleep Associated Monitoring Index (SAMI) and the Pre-sleep Arousal Scale (PSAS). They will also complete neuropsychological tasks (Neuropsychological Assessment Battery subtests: Digits Backward, Story Learning, Daily Living Memory and Word Generation) which will assess attention, working memory, executive function and memory. Volunteers identified as having primary sleep disorders will be referred to their General Practitioner and/or a local sleep physician and will not be eligible for the trial.
Randomisation
Randomisation will take place after the above screening visits. An un-blinded research assistant will generate and retain a computer-generated random number list throughout the study. Subjects will be stratified by gender and age with a cut point of 70 years old and then randomised to one of the treatment groups. The research assistant will discuss the time requirements of the study with each participant (i.e. 2 exercise classes per week and the desirability of 4 practice sessions at home) and their exercise times will be decided on. Participants will be mailed a basic instruction leaflet with their exercise class dates and times, a plan for good sleep hygiene and copies of a 1 week sleep log with instructions to complete this for the week following and for the last week of each month. They will also be asked to keep a record of all their health care utilisation for the entire 3 month period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4665 0
Government body
Name [1] 4665 0
National Health and Medical Research Council (NHMRC)
Country [1] 4665 0
Australia
Primary sponsor type
University
Name
Royal Melbourne Institute of Technology (RMIT) University
Address
Plenty Rd, Bundoora West, Bundoora, 3083 Victoria
Country
Australia
Secondary sponsor category [1] 4211 0
Hospital
Name [1] 4211 0
Austin Hospital
Address [1] 4211 0
145 Studley Road, Heidelberg, 3084, Victoria
Country [1] 4211 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 6702 0
RMIT Human Research Ethics Committee (HREC)
Ethics committee address [1] 6702 0
Ethics committee country [1] 6702 0
Australia
Date submitted for ethics approval [1] 6702 0
15/03/2009
Approval date [1] 6702 0
Ethics approval number [1] 6702 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29396 0
Address 29396 0
Country 29396 0
Phone 29396 0
Fax 29396 0
Email 29396 0
Contact person for public queries
Name 12643 0
Prof Marc Cohen
Address 12643 0
PO Box 71 Bundoora, Victoria, 3083
Country 12643 0
Australia
Phone 12643 0
+61 3 9925 7440
Fax 12643 0
+61 3 9925 7178
Email 12643 0
[email protected]
Contact person for scientific queries
Name 3571 0
Prof Marc Cohen
Address 3571 0
PO Box 71 Bundoora, Victoria, 3083
Country 3571 0
Australia
Phone 3571 0
+61 3 9925 7440
Fax 3571 0
+61 3 9925 7178
Email 3571 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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