- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07598123
Effects of Multi-component Exercise on Physical Performance and Sleep Quality in Older Adults
Effects of a Multi-component Group Exercise Program on Physical Performance and Sleep Quality in Older Adults: A Quasi-Experimental Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Population ageing increases the importance of interventions that promote healthy ageing and prevent functional decline. Exercise interventions have demonstrated benefits for mobility, muscular strength, balance, cardiovascular health, and quality of life in older adults. However, evidence regarding structured multi-component exercise programs integrated with senior-friendly smart fitness equipment and their effects on sleep quality remains limited.
This study aimed to evaluate the effects of an 8-week multi-component group exercise program on physical performance and sleep quality in community-dwelling older adults in Taiwan. The intervention was designed according to the American College of Sports Medicine (ACSM) recommendations for older adults and incorporated aerobic exercise, resistance training, balance training, and flexibility exercises.
Participants in the intervention group attended weekly 100-minute exercise sessions consisting of warm-up activities, whole-body vibration training, treadmill or stationary bicycle aerobic exercise, hydraulic-based isokinetic resistance training, and cool-down exercises. Exercise intensity was monitored using heart rate and session rating of perceived exertion (sRPE). The control group maintained their regular community activities without structured exercise intervention.
The primary outcomes were changes in physical performance and sleep quality. Secondary outcomes included heart rate recovery as an indicator of cardiovascular fitness. This study provides evidence regarding the feasibility and effectiveness of community-based multi-component exercise programs for older adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 407224
- Tunghai University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: an 8-week multi-component group exercise program
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.
|
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.
Other Names:
|
|
No Intervention: Routine community activities
Control Group: Participants continued their routine community activities without participating in the structured exercise intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the 4-meter Gait Speed Test
Time Frame: Baseline and week 8
|
4-meter Gait Speed Test
|
Baseline and week 8
|
|
Chair Stand Test
Time Frame: Baseline and week 8
|
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
Time Frame: baseline and week 8
|
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
Time Frame: baseline and week 8
|
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
Time Frame: baseline and week 8
|
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
Time Frame: baseline and week 8
|
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
Time Frame: baseline and week 8
|
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
Time Frame: Baseline and week 8
|
Assessment of sleep quality using the Chinese version of the Pittsburgh Sleep Quality Index (CPSQI)
|
Baseline and week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Recovery
Time Frame: baseline and weekly from Week 1 to Week 8
|
Assessment of cardiovascular recovery using heart rate recovery measured two minutes after treadmill exercise
|
baseline and weekly from Week 1 to Week 8
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yi-Ling Tseng, MSN, Tunghai University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS1-24033
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Aging
-
Tuba MadenCompletedAging | Aging Problems | Aging Disorder
-
Florida Institute for Human and Machine CognitionNot yet recruitingAging | Healthy Aging | Aging WellUnited States
-
University of CopenhagenRecruitingAging | Healthy Aging | Aging FrailtyDenmark
-
Radboud University Medical CenterTerminated
-
Northwestern UniversityPotocsnak Human Longevity LabRecruitingAging | Aging Well | Aging, Biological | Aging, HealthyUnited States
-
TruDiagnosticBlushield USANot yet recruitingAging | Aging Well
-
Arizona State UniversityActive, not recruiting
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Centre Hospitalier Universitaire de NiceNot yet recruitingAging | Aging, HealthyFrance
Clinical Trials on Multi-component Group Exercise Program
-
University of MaiaResearch Center in Sports Sciences, Health Sciences and Human DevelopmentRecruitingFall Prevention | Functional Mobility | Balance Control in Elderly | Muscle Power PerformancePortugal
-
Affiliated Hospital of Nantong UniversityRecruitingIschemic Stroke | Frailty | Exercise TherapyChina
-
University of Erlangen-Nürnberg Medical SchoolADAC (The General German Automobile Club) foundationCompleted
-
Universidad Católica San Antonio de MurciaCompletedELDERLY PEOPLESpain
-
US Department of Veterans AffairsCompletedAging | Mobility LimitationsUnited States
-
University of SevilleCompletedPhysical Activity | Aging | Physiotherapy | Vestibular DisorderSpain
-
Universidad Iberoamericana A.C., MexicoCompleted
-
Johns Hopkins UniversityGeorgetown University; National Institute of Environmental Health Sciences... and other collaboratorsNot yet recruiting
-
Charite University, Berlin, GermanySenatsverwaltung für Bildung, Wissenschaft und Forschung, Berlin, Germany; KARUNA...UnknownTobacco Use DisorderGermany