NCT07598123

Brief Summary

This quasi-experimental study evaluated the effects of an 8-week multi-component group exercise program on physical performance and sleep quality among community-dwelling older adults in Taiwan. Participants were recruited from four community care sites in central Taiwan. The intervention group participated in a structured exercise program consisting of aerobic, resistance, balance, and flexibility training conducted at a university-affiliated senior fitness club, while the control group maintained their usual community activities. Primary outcomes included physical performance and sleep quality. Physical performance was assessed using gait speed, chair stand, arm curl, grip strength, balance, and walking tests. Sleep quality was measured using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI). Heart rate recovery was evaluated as a secondary outcome. Pre- and post-intervention assessments were conducted to determine the effectiveness of the intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

May 29, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2025

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

May 12, 2026

Last Update Submit

May 18, 2026

Conditions

Keywords

older adultsexercisesleep qualityphysical performance

Outcome Measures

Primary Outcomes (8)

  • the 4-meter Gait Speed Test

    4-meter Gait Speed Test

    Baseline and week 8

  • Chair Stand Test

    The Chair Stand Test assesses lower-body muscle strength by measuring the time required for participants to complete five chair stands consecutively with arms crossed over the chest.

    Baseline and week 8

  • 30-second Arm Curl Test

    The 30-second Arm Curl Test assesses upper-body muscle endurance by counting the number of arm curls completed within 30 seconds using a dumbbell weighing 2.27 kg for women and 3.63 kg for men.

    baseline and week 8

  • Grip Strength Test

    The Grip Strength Test assesses hand muscle strength using a hand dynamometer. Participants perform maximal grip force with the dominant hand, and the measured force is recorded in kilograms.

    baseline and week 8

  • Side-by-Side Stand Test

    The Side-by-Side Stand Test assesses static balance by measuring the participant's ability to maintain a side-by-side standing position without assistance.

    baseline and week 8

  • Tandem Stand Test

    The Tandem Stand Test assesses static balance by measuring the length of time participants can maintain a heel-to-toe standing position, up to a maximum of 10 seconds.

    baseline and week 8

  • 2.44-meter Timed Walk Test

    The 2.44-meter Timed Walk Test assesses mobility and dynamic balance by recording the time required for participants to stand up from a seated position, walk 2.44 meters around a cone, and return to the chair.

    baseline and week 8

  • Sleep Quality

    Assessment of sleep quality using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)

    Baseline and week 8

Secondary Outcomes (1)

  • Heart Rate Recovery

    baseline and weekly from Week 1 to Week 8

Study Arms (2)

an 8-week multi-component group exercise program

EXPERIMENTAL

Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, and cool-down activities. Exercise intensity was monitored using heart rate and perceived exertion.

Behavioral: Multi-component Group Exercise Program

Routine community activities

NO INTERVENTION

Control Group: Participants continued their routine community activities without participating in the structured exercise intervention.

Interventions

Participants attended weekly 100-minute supervised exercise sessions including warm-up stretching, aerobic exercise using treadmills and stationary bicycles, whole-body vibration training, resistance exercise using hydraulic isokinetic equipment, and cool-down activities. Exercise intensity was monitored using heart rate and perceived exertion.

Also known as: Exercise
an 8-week multi-component group exercise program

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Community-dwelling older adults aged 65 to 90 years.
  • Able to communicate in Mandarin or Taiwanese.
  • Able to participate in exercise activities.
  • Provided written informed consent.

You may not qualify if:

  • Contraindications to exercise, including recent myocardial infarction, acute cardiovascular events, acute infection, or renal disease symptoms.
  • Use of ambulatory assistive devices.
  • Regular physical activity exceeding 150 minutes per week.
  • Positive responses indicating elevated exercise risk on the Physical Activity Readiness Questionnaire (PAR-Q).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunghai University

Taichung, 407224, Taiwan

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Yi-Ling Tseng, MSN

    Tunghai University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: Participants from two community care sites were assigned to the intervention group, while participants from two additional community care sites were assigned to the control group. The intervention group participated in an 8-week multi-component exercise program, whereas the control group maintained their usual community activities.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 12, 2026

First Posted

May 20, 2026

Study Start

May 29, 2024

Primary Completion

December 19, 2024

Study Completion

May 18, 2025

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations