Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chang Gung Memorial Hospital
- Trial code
- NCT07896603
- Record updated
- 29 October 2026
- Original description
Background:Read full original descriptionShow less
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.
Inclusion: Age ≥ 50 years old; Sedative-hypnotic use for more than 6 months.
Exclusion: Currently under psychotherapy or ever received non-pharmacological treatment for insomnia; Unstable or severe medical conditions that may interfere with participation, such as uncontrolled cardiovascular disease, advanced chronic obstructive pulmonary disease, recent stroke (<6 months), or severe renal/hepatic failure; Neuromuscular or orthopedic disorders that limit safe participation in resistance training (e.g., severe arthritis, recent fractures, progressive neuromuscular diseases); Current diagnosis of major psychiatric disorders (e.g., uncontrolled major depressive disorder, bipolar disorder, psychosis) that may impair adherence; Any condition judged by the investigator to pose a safety risk or interfere with study participation; Inability to perform informed consent; Current participation in a structured exercise program ≥2 days/week in the last 3 months, which may confound intervention effects.