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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Gizem Limnili, MD
- Telefonnummer: +902324124951
- E-Mail: gizem.limnili@deu.edu.tr
Studieren Sie die Kontaktsicherung
- Name: Makbule Neslişah Tan, Associate Professor
- Telefonnummer: +902324124951
- E-Mail: neslisah.tan@deu.edu.tr
Studienorte
-
-
-
Izmir, Türkei (türkiye)
- Dokuz Eylul University Faculty of Medicine Department of Family Medicine
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
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. |
|
Kein Eingriff: 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:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Cognitive function
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Physical activity level
Zeitfenster: 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
|
Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Demographic and clinical characteristics
Zeitfenster: 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
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Gizem Limnili, Dokuz Eylul University Faculty of Medicine Department of Family Medicine
- Hauptermittler: Makbule Neslişah Tan, Dokuz Eylul University Faculty of Medicine Department of Family Medicine
- Studienstuhl: Vildan Mevsim, Prof, Dokuz Eylul University Faculty of Medicine Department of Family Medicine
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025/45-39
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .