NCT07027176

Brief Summary

This study aims to explore whether increasing physical activity can improve sleep quality in older adults, particularly those with poor sleep, and whether such improvements positively influence cognitive functions such as memory and attention. The goal is to provide a practical intervention strategy to enhance both sleep quality and cognitive function, contributing to healthy aging.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress58%
Jun 2025Dec 2026

First Submitted

Initial submission to the registry

June 10, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

June 15, 2025

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 18, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.5 years

First QC Date

June 10, 2025

Last Update Submit

June 10, 2025

Conditions

Keywords

sleep qualityphysical activitymemoryattention

Outcome Measures

Primary Outcomes (5)

  • Chinese version of the Pittsburgh Sleep Quality Index

    sleep quality

    From pre-intervention to the end of intervention at 12 weeks

  • Digital Span Test

    short-term memory and attention

    From pre-intervention to the end of intervention at 12 weeks

  • Chinese version Verbal Learning Test

    short-term memory

    From pre-intervention to the end of intervention at 12 weeks

  • Chinese Version Trail Making Test

    attention

    From pre-intervention to the end of intervention at 12 weeks

  • Chinese version of Stroop Color and Word test

    attention

    From pre-intervention to the end of intervention at 12 weeks

Secondary Outcomes (5)

  • Montreal Cognitive Assessment

    From pre-intervention to the end of intervention at 12 weeks

  • Six-Minute Walk Test

    From pre-intervention to the end of intervention at 12 weeks

  • Multidimensional Fatigue Inventory

    From pre-intervention to the end of intervention at 12 weeks

  • Depression Anxiety Stress Scales-21

    From pre-intervention to the end of intervention at 12 weeks

  • Heart rate variability

    From pre-intervention to the end of intervention at 12 weeks

Study Arms (5)

low-intensity exercise in the morning

EXPERIMENTAL
Behavioral: walking exercise

moderate-intensity exercise in the morning

EXPERIMENTAL
Behavioral: walking exercise

low-intensity exercise at night

EXPERIMENTAL
Behavioral: walking exercise

moderate-intensity exercise at night

EXPERIMENTAL
Behavioral: walking exercise

control group

NO INTERVENTION

Interventions

Divided into low-intensity and moderate-intensity exercise intervention groups, participants exercised either during the day or at night. The intervention lasted for 12 weeks.

low-intensity exercise at nightlow-intensity exercise in the morningmoderate-intensity exercise at nightmoderate-intensity exercise in the morning

Eligibility Criteria

Age60 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 60 and 80
  • Montreal Cognitive Assessment score \> 26
  • Pittsburgh Sleep Quality Index score \> 5
  • Not participated in any regular exercise program in the past 3 months
  • Being able to understand and follow the exercise program

You may not qualify if:

  • Suffering from any neurological or musculoskeletal disorders
  • Visual problems
  • Geriatric Depression Scale score ≥ 6
  • Vestibular disease or vestibular dysfunction
  • Being unable to walk independently due to neuromuscular or musculoskeletal limitations
  • A history of mental illness
  • Untreated obstructive sleep apnea
  • A history of electroconvulsive therapy or severe head injury leading to prolonged unconsciousness
  • A history of alcoholism or dependence within the past 2 years
  • A history of cancer within the past 5 years
  • Any major systemic diseases, unstable medical conditions (such as insulin-dependent diabetes or uncontrolled diabetes, uncontrolled hypertension (systolic pressure \> 170 or diastolic pressure \> 100 mmHg)),
  • Taking medications that affect the central nervous system, balance, coordination, or sleep (such as antidepressants, vestibular sedatives or anxiolytics, sleep aids)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy and Assistive Technology

Taipei, 112304, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMotor Activity

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavior

Central Study Contacts

Yea-Ru Yang, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 10, 2025

First Posted

June 18, 2025

Study Start

June 15, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations