NCT07596082

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
3mo left

Started Aug 2026

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 25, 2026

Completed
24 days until next milestone

First Posted

Study publicly available on registry

May 19, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

April 25, 2026

Last Update Submit

May 12, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Cognitive function

    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 Outcomes (1)

  • Physical activity level

    Day 0, 3. Month, 6. Month

Other Outcomes (2)

  • Demographic and clinical characteristics

    Day 0

  • Stage of behavioral change

    Day 0, 3. Month, 6. Month

Study Arms (2)

Artificial intelligence-supported chatbot and educational brochure on the importance of exercise

EXPERIMENTAL

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: * Interactive, on-demand communication regarding physical activity and exercise * Personalized educational messages tailored to participant needs and engagement patterns * Motivational support and behavioral prompts to encourage adherence to physical activity recommendations The brochure will provide standardized, non-interactive information on: * The importance and health benefits of regular exercise * General physical activity recommendations This intervention arm differs from comparator arms by incorporating an interactive, adaptive, and continuous AI-based support system.

Behavioral: Artificial intelligence-supported chatbot

Control (Brochure Only) Group

NO INTERVENTION

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: * The importance and health benefits of regular exercise * General physical activity recommendations In addition to receiving the brochure, participants will: * Continue their usual daily activities and routine care * Do not have access to the artificial intelligence-supported chatbot * Not receive any personalized, interactive, or ongoing digital support or behavioral prompts during the study period This group differs from the experimental arm by receiving only static educational material, without any interactive or adaptive behavioral support system.

Interventions

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.

Artificial intelligence-supported chatbot and educational brochure on the importance of exercise

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dokuz Eylul University Faculty of Medicine Department of Family Medicine

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityHealth Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Gizem Limnili

    Dokuz Eylul University Faculty of Medicine Department of Family Medicine

    STUDY DIRECTOR
  • Makbule Neslişah Tan

    Dokuz Eylul University Faculty of Medicine Department of Family Medicine

    PRINCIPAL INVESTIGATOR
  • Vildan Mevsim, Prof

    Dokuz Eylul University Faculty of Medicine Department of Family Medicine

    STUDY CHAIR

Central Study Contacts

Makbule Neslişah Tan, Associate Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 25, 2026

First Posted

May 19, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

May 19, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations