Regular Exercise and Sleep Trial

Category Primary study
Registry of TrialsANZCTR
Year 2009
INTERVENTION: 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. CONDITION: Insomnia SECONDARY OUTCOME: 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. 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. 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. 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?) 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%). 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. 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. PRIMARY OUTCOME: 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. 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. 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. 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. 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
Epistemonikos ID: d318793a4fb9fff92d11bf0b22518ba0d4be120b
First added on: Aug 25, 2024