Trial · NCT07896603
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
NCT07896603, Not applicable, Enrolling by invitation, Chang Gung Memorial Hospital
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia. Trials, record NCT07896603. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07896603
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
- NCT number
- NCT07896603
- Status
- Enrolling by invitation
- Phases
- Not applicable
- Enrollment
- 40 participants, estimated
- Lead sponsor
- Chang Gung Memorial Hospital
- Conditions
- Insomnia Chronic, Hypnotics and Sedatives, Physical Activities
- Interventions
- resistance training, Relaxation training
- First posted
- 2026-10-27
- Last updated
- 2026-10-29
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Daily Dose equivalent for statistical purpose (S-DDD) | baseline and three-month post-intervention assessment | 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. |
| Secondary | Global Physical Activity Questionnaire (GPAQ) | baseline and three months after the end of interventions | 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. |
| Secondary | The Pittsburgh Sleep Quality Index (PSQI) | baseline and three months after the end of interventions | 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) |
| Secondary | Polysomnography (PSG) | baseline and three months after the end of interventions | 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. |
| Secondary | Skeletal Muscle Mass Adjusted for BMI | baseline and three months after the end of interventions | Skeletal muscle mass was assessed using dual-energy X-ray absorptiometry (DXA). Skeletal muscle mass was adjusted for body mass index (BMI) by dividing the measured skeletal muscle mass by the participant's BMI. Changes in BMI-adjusted skeletal muscle mass from baseline to 3-months after the end of interventions were compared within participants, and differences in changes between groups were examined.For participants aged ≥65 years old, the cut-off values were less than 0.73 for men and less than 0.52 for women. For participants aged 50-64 years old, the cut-off values were less than 0.80 for men and less than 0.55 for women. Unit of Measure: kg/m² |
| Secondary | Handgrip strength | Baseline and three months after the end of interventions | Handgrip strength was assessed using a handgrip dynamometer. Changes in handgrip strength from baseline to three months after the end of interventions were compared within participants, and differences in changes between groups were examined.For participants aged ≥65 years old, the cut-off values were less than 28 kg for men and less than 18 kg for women. For participants aged 50-64 years old, the cut-off values were less than 34 kg for men and less than 20 kg for women. Unit of Measure: Kilograms (kg) |
| Secondary | Calf circumference | Baseline and three months after the end of interventions | Calf circumference was measured in centimeters. Changes in calf circumference from baseline to after three months after the end of interventions compared within participants, and differences in changes between groups were examined.The cut-off values for calf circumference were less than 34 cm for men and less than 33 cm for women. These cut-off values were applied to both ≥65 years and 50-64 years old. Unit of Measure: Centimeters (cm) |
| Secondary | Gait speed | Baseline and three months after the end of interventions | Gait speed was assessed by measuring the time required to walk a 6-meter distance at the participant's usual walking pace. Changes in gait speed from baseline to after three months after the end of interventions were compared within participants, and differences in changes between groups were examined.For participants aged ≥65 years old, the cut-off value was less than 1.0 m/s for both men and women. For participants aged 50-64 years old, the cut-off value was less than 1.2 m/s for both men and women. Unit of Measure: Meters per second (m/s) |
| Secondary | Five-times chair stand test | Baseline and three months after the end of interventions | Physical performance was assessed using the five-times chair stand test, with the time required to complete the test recorded in seconds. Changes in completion time from baseline to three months after the end of interventions were compared within participants, and differences in changes between groups were examined.For participants aged ≥65 years old, the cut-off value was ≥12.0 seconds for both men and women. For participants aged 50-64 years old, the cut-off value was ≥10.0 seconds for both men and women. Unit of Measure: Seconds (s) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07896603
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