An interventional study of resistance training and Relaxation training in Insomnia Chronic, Hypnotics and Sedatives and Physical Activities, sponsored by Chang Gung Memorial Hospital. Enrolling by invitation at 1 site in Taiwan. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
Background:
The prevalence of sedative-hypnotic use among middle-aged and older adults in Taiwan has continued to rise, highlighting the need to better understand the underlying factors contributing to sleep disturbances and medication dependence. Emerging evidence suggests that, beyond psychological and behavioral contributors, age-related physiological decline may play an important role. Sarcopenia, characterized by progressive loss of muscle mass and strength, is common in aging populations and has been linked to poor sleep quality, daytime fatigue, increased fall risk, and higher medication use. Regular physical activity not only improves symptoms of sarcopenia but has also been shown to enhance subjective sleep quality and modify objective sleep architecture, including increases in N3 slow-wave sleep. Despite these benefits, no study to date has directly examined whether physical activity can facilitate sedative-hypnotic dose reduction among chronic users.
Purpose:
The aim of this study is to investigate the associations among sarcopenia, sleep disturbances, and sedative-hypnotic use, and to evaluate the effectiveness of a structured physical activity intervention in improving subjective and objective sleep outcomes and promoting dose reduction in chronic hypnotic users.
Methods:
This three-year study will recruit 180 adults aged 50 years and older who have long-term sedative-hypnotic use. Participants will be randomly assigned to either an individualized 12-week physical activity program or a relaxation training control condition. Baseline and post-intervention assessments will include subjective sleep questionnaires, polysomnography, muscle strength and mass measurements, and standardized hypnotic dose quantification.
Expected Results:
Investigators anticipate that physical activity targeting muscle health will significantly improve sleep quality and contribute to meaningful reductions in sedative-hypnotic medication use among chronic users.
1,933 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 616 are open to participants now.
This study's planned enrollment of 40 is below the median of 72 across 1,694 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
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Exclusion Criteria:
Behavioral: resistance training
Behavioral: Relaxation training
The program will rely mainly on body weight movements supplemented with elastic resistance bands and will be performed at an intensity corresponding to eight to twelve repetition maximum.
This training will include instruction in abdominal breathing and progressive muscle relaxation. An audio recording of the relaxation script will be provided, and participants will be asked to practice at home one to two times each week for a total duration of three months.
Daily Dose equivalent for statistical purpose (S-DDD)
Sedative-hypnotic medications constitute a heterogeneous group that includes benzodiazepines, non-benzodiazepine Z-drugs, and other agents with sleep-promoting properties. Because these medications vary substantially in potency, half-life, receptor specificity, and clinically prescribed daily doses, direct comparison of milligram quantities is not meaningful. To permit standardized analysis, the prescribed dose of each hypnotic medication will be converted into its corresponding WHO Defined Daily Dose equivalent for statistical purpose (S-DDD). The dosage of sedative-hypnotic medications was standardized by dividing each participant's prescribed dose by the World Health Organization assigned Defined Daily Dose (DDD) for the corresponding medication (WHO Collaborating Centre for Drug Statistics Methodology, 2024), expressed in DDDs. Changes in medication use from baseline to the three-month post-intervention assessment were compared both within and between the two groups.
Time frame: baseline and three-month post-intervention assessment
Global Physical Activity Questionnaire (GPAQ)
Physical activity levels were assessed using the Global Physical Activity Questionnaire (GPAQ) following WHO scoring guidelines (Keating et al., 2019). Weekly minutes of vigorous, moderate, and transport-related activity were multiplied by assigned MET values (8.0 for vigorous, 4.0 for moderate and transport) to calculate MET-minutes per week. Total physical activity was obtained by summing MET-minutes across all domains. Higher MET values indicate higher levels of physical activity among participants. Differences in MET values at baseline and after the 3-month intervention were compared both within participants and between the two groups.
Time frame: baseline and three months after the end of interventions
The Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a predominant, self-reported measurement tool for evaluating subjective sleep quality. This instrument is structured around nineteen individual items which are aggregated into seven distinct component scores. These components comprehensively cover key dimensions of sleep, specifically: sleep duration, sleep latency, habitual sleep efficiency, frequency of sleep disturbances, reliance on sleep medication, presence of daytime dysfunction, and the individual's global perception of their sleep quality. Each of the seven components is rated on a 0 to 3 scale, which generates a final Global PSQI Score ranging from 0 to 21 with higher values indicating poorer sleep quality. A global score greater than five is commonly used as the clinical cutoff for identifying individuals with meaningful sleep disturbance. The PSQI has demonstrated strong reliability, validity, and sensitivity to change across a wide range of populations (Buysse et al., 1989)
Time frame: baseline and three months after the end of interventions
Polysomnography (PSG)
Polysomnography (PSG) records multiple physiological signals simultaneously during an overnight sleep study, including electroencephalography (EEG), electrooculography (EOG), and electromyography (EMG), to evaluate brain activity, eye movements, and muscle tone. These measurements enable accurate identification of sleep stages, including non-rapid eye movement (NREM) stages N1, N2, and N3, as well as rapid eye movement (REM) sleep, allowing detailed assessment of sleep architecture. It also incorporates additional monitoring, such as airflow and oxygen saturation, to detect sleep-related breathing disorders and other physiological abnormalities. Furthermore, it provides quantitative measures of sleep continuity, including total sleep time, sleep efficiency, and sleep onset latency, together with physiological events such as arousals and respiratory events. PSG allow researchers to comprehensively evaluate participants' sleep characteristics.
Time frame: baseline and three months after the end of interventions
Sarcopenia evaluation
According to the latest 2025 guidelines released by the Asian Working Group for Sarcopenia (AWGS), the assessment of sarcopenia includes handgrip strength (kg), calf circumference (cm), gait speed (m/s), five-times chair stand test (s), and dual-energy X-ray absorptiometry (DXA). DXA was used to assess skeletal muscle mass. The skeletal muscle mass was adjusted by dividing the muscle mass value by the participant's BMI to enable comparisons among participants, with the unit expressed as kg/m². In this study, changes in sarcopenia-related parameters, including handgrip strength, calf circumference, gait speed, five-times chair stand time, and muscle mass adjusted for BMI, were compared within participants between baseline and after the 3-month intervention. Differences in these parameters were also examined between groups.
Time frame: baseline and three months after the end of interventions
Plan to share: Undecided
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