- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07596082
Development of a Chatbot-supported Personalized Exercise Program for Older Adults and Evaluation of Its Effects on Cognitive Functions
The purpose of this study is to develop an artificial intelligence-based chatbot application to support exercise behavior in individuals aged 60 and over who do not regularly exercise, and to evaluate its effectiveness. In addition, the study aims to examine the effects of changes in exercise habits on the cognitive (mental) functions of older adults.
In this study, the impact of a chatbot-supported personalized exercise program on cognitive functions in older individuals will be evaluated. A total of 90 participants is planned for inclusion in this study.
If you agree to participate in this study, depending on the group you are assigned to, you may receive:
- An artificial intelligence-based chatbot program, along with educational materials about the importance of exercise, or
- Only educational materials (brochures) prepared by the researchers about the importance of exercise.
At the beginning of the study, you will be asked to complete a data collection form. The same form will also be administered at week 12 and week 24.
This form will include:
- Basic information such as your age and gender,
- Questions about your exercise habits,
- A brief test to assess your cognitive (mental) functions,
- Questions evaluating your level of physical activity. The study duration is 24 weeks, including 12 weeks of intervention and 12 weeks of follow-up.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gizem Limnili, MD
- Phone Number: +902324124951
- Email: gizem.limnili@deu.edu.tr
Study Contact Backup
- Name: Makbule Neslişah Tan, Associate Professor
- Phone Number: +902324124951
- Email: neslisah.tan@deu.edu.tr
Study Locations
-
-
-
Izmir, Turkey (Türkiye)
- Dokuz Eylul University Faculty of Medicine Department of Family Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 65 years and older
- Normal or mildly impaired cognitive status
- Medical condition that does not prevent participation in physical activity
- Ability to use a smartphone or tablet (for chatbot access)
- Voluntary participation
Exclusion Criteria:
- Moderate to severe dementia
- Severe depression or serious psychiatric disorders
- Acute cardiovascular risk
- Communication difficulties due to significant hearing or visual impairment
- Regular engagement in structured exercise within the past 6 months (participants in the maintenance phase of exercise behavior)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Artificial intelligence-supported chatbot and educational brochure on the importance of exercise
Participants assigned to this arm will receive a combined digital and educational intervention designed to promote behavior change in physical activity. In addition to a standard researcher-developed informational brochure describing the health benefits of exercise, participants will have access to a chatbot supported by artificial intelligence technology. The chatbot will provide:
The brochure will provide standardized, non-interactive information on:
|
Participants will receive a combined behavioral intervention of an educational brochure developed by the Ministry of Health and access to an artificial intelligence (AI)-supported chatbot designed to promote physical activity. The brochure will provide standardized written information on the importance of exercise, including general recommendations, health benefits, and basic guidance for an active lifestyle. Participants will also have access to an AI-supported chatbot throughout the intervention period. The chatbot will deliver automated, interactive messages to increase physical activity, including motivational prompts, educational reinforcement, and behavior-change support. The intervention will be delivered digitally via the chatbot platform, with no medication or physical devices required. The total duration and frequency of chatbot interactions will be continuous and on-demand during the study period. |
|
No Intervention: Control (Brochure Only) Group
Participants assigned to this arm will receive a standard researcher-developed informational brochure on the importance of exercise, but will not receive any digital or interactive intervention. The brochure will provide standardized, non-interactive information on:
In addition to receiving the brochure, participants will:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognitive function
Time Frame: Day 0, 3. Month, 6. Month
|
Cognitive function will be assessed using the Mini-Mental State Examination (MMSE), a standardized tool evaluating orientation, memory, attention, language, and visuospatial abilities.
Higher scores indicate better cognitive performance.
|
Day 0, 3. Month, 6. Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical activity level
Time Frame: Day 0, 3. Month, 6. Month
|
Physical activity level will be measured using the Physical Activity Scale for the Elderly (PASE), which assesses the frequency and duration of physical activity in older adults, including leisure, household, and occupational activities.
Higher scores indicate higher physical activity levels.
|
Day 0, 3. Month, 6. Month
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Demographic and clinical characteristics
Time Frame: Day 0
|
Participant demographic and clinical data will be collected, including age, sex, education level, presence of chronic diseases, and medication use.
These variables will be recorded only at baseline.
|
Day 0
|
|
Stage of behavioral change
Time Frame: Day 0, 3. Month, 6. Month
|
Participants' stage of change according to the Transtheoretical Model (TTM) will be assessed to determine their readiness for physical activity behavior change.
This assessment will be used to tailor chatbot-based behavioral change techniques grounded in TTM and COM-B frameworks, enabling stage-matched intervention delivery.
|
Day 0, 3. Month, 6. Month
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Gizem Limnili, Dokuz Eylul University Faculty of Medicine Department of Family Medicine
- Principal Investigator: Makbule Neslişah Tan, Dokuz Eylul University Faculty of Medicine Department of Family Medicine
- Study Chair: Vildan Mevsim, Prof, Dokuz Eylul University Faculty of Medicine Department of Family Medicine
Study record dates
Study Major Dates
Study Start (Estimated)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2025/45-39
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
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