- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457996
Effects of Adapted Sports on Balance, Physical Function, and Cognitive Function in Older Adults (ASF)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aging is associated with declines in balance, physical function, and cognitive abilities, which may increase the risk of falls and reduce independence in daily life. Adapted sports and structured physical activity programs are considered effective strategies for maintaining functional capacity and cognitive health among older adults.
This randomized controlled study aims to examine the effects of an adapted sports exercise program on balance, physical function, and cognitive function in older individuals. Eligible participants will be randomly assigned to either an intervention group or a control group. The intervention group will participate in a supervised adapted sports exercise program designed to improve balance, coordination, strength, and functional mobility. The control group will continue their usual lifestyle without participating in the structured exercise program.
Outcome measures will include assessments of balance, physical performance, and cognitive function. Standardized measurement tools will be applied before and after the intervention period to evaluate changes in these parameters. The results of this study will provide evidence on the potential benefits of adapted sports activities for promoting healthy aging and improving functional and cognitive outcomes in older adults.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Antalya
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Alanya, Antalya, Turkey (Türkiye), 07450
- Alanya Alaaddin Keykubat University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
• Being 60 years of age or older
- Having the ability to speak and understand Turkish
- Being able to regularly attend at least 10 sessions during the 12-week intervention period
- Having no serious cardiovascular, neurological, orthopedic, systemic, or psychiatric diseases
- Having no cognitive or sensory impairment
- Obtaining physician approval indicating that participation in the adapted sports program does not pose a health risk
- Voluntarily agreeing to participate in the study
- Agreeing to follow the study procedures and comply with the principle of continuity
Exclusion Criteria:
- Voluntary withdrawal from the study by the participant
- Failure to attend the intervention sessions for more than two consecutive weeks during the 12-week intervention period
- Inability to continue participation due to a health problem that develops during the intervention period
- Development of chronic diseases or use of medications during the study period that may affect the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Adapted Sports Exercise Group
Participants in this group will take part in a 12-week adapted sports exercise program performed three times per week.
The program will include structured physical activity sessions designed to improve balance, physical function, and cognitive performance in older adults.
|
Participants will take part in an adapted sports exercise program designed for older adults.
The program will be conducted for 12 weeks, three times per week.
Each session will last approximately 45-60 minutes and will include balance, coordination, strength, and mobility exercises.
The exercises are adapted to the physical capacities of the participants and supervised by a qualified instructor.
|
|
No Intervention: Control Group
Participants in the control group will continue their usual daily activities and will not participate in the adapted sports exercise program during the study period.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance
Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Balance will be assessed using the Berg Balance Scale, a 14-item scale used to evaluate functional balance in older adults.
Each item is scored from 0 to 4, and the total score ranges from 0 to 56, with higher scores indicating better balance performance.
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility and Balance (Tinetti Performance Oriented Mobility Assessment)
Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Mobility and balance will be assessed using the Tinetti Performance Oriented Mobility Assessment, which evaluates gait and balance performance in older adults.
The total score ranges from 0 to 28, with higher scores indicating better mobility and balance performance and lower fall risk.
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Functional Fitness (Senior Fitness Test)
Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Physical function will be assessed using components of the Senior Fitness Test, which evaluates functional fitness in older adults including strength, flexibility, balance, and aerobic endurance.
Higher performance in test components indicates better physical function.
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
|
Cognitive Function (Montreal Cognitive Assessment)
Time Frame: Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Cognitive function will be evaluated using the Montreal Cognitive Assessment, a screening tool for mild cognitive impairment.
Scores range from 0 to 30, with higher scores indicating better cognitive performance.
|
Baseline (pre-intervention) and 12 weeks (post-intervention)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- CGT-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
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