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ENROLLING BY INVITATION
NCT07896603
NA

Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-07-01

Completion Date

2027-07

Last Updated

2026-10-29

Healthy Volunteers

No

Interventions

BEHAVIORAL

resistance 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.

BEHAVIORAL

Relaxation training

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.

Locations (1)

Chang Gung Memorial Hospital

Keelung, Taiwan