- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07832097
Effectiveness of a Smartphone Chatbot to Improve Exercise Adherence in Older Adults (EXEBOT)
Effectiveness of a Smartphone-Based Chatbot on Adherence to a Home-Based Multicomponent Exercise Program and Physical Function in Older Adults: A Randomized Controlled Trial
This randomized controlled trial aims to evaluate the effectiveness of a smartphone-based chatbot in improving adherence to a 12-week home-based multicomponent exercise program in community-dwelling older adults. Participants will be randomly assigned to receive either a chatbot-supported exercise program delivered through Telegram or an equivalent paper-based exercise program. Both groups will perform the same exercise program, including strength, balance, flexibility, and walking exercises. The primary outcome is exercise adherence. Secondary outcomes include physical function, physical activity, participant satisfaction, usability of the chatbot, and adverse events. The study seeks to determine whether chatbot-based support can enhance adherence and improve health outcomes in older adults.
Přehled studie
Postavení
Podmínky
Detailní popis
Population aging is associated with declines in physical function, mobility, and independence. Home-based multicomponent exercise programs are effective strategies to maintain physical function and reduce the risk of disability in older adults; however, adherence to exercise programs remains a major challenge, particularly when exercises are performed without direct supervision. Effectiveness of a Smartphone-Based Chatbot on Adherence to a Home-Based Multicomponent Exercise Program and Physical Function in Older Adults: A Randomized Controlled Trial addresses this challenge by evaluating a digital intervention specifically designed to support exercise adherence.
This study is a two-arm, parallel-group randomized controlled trial conducted in community-dwelling adults aged 60 years and older. Participants are randomly allocated in a 1:1 ratio to either a chatbot-supported exercise program or a paper-based exercise program. Both groups receive the same 12-week home-based multicomponent exercise program, consisting of three exercise sessions per week. The intervention includes strength, balance, flexibility, and walking exercises with a predefined progression throughout the program.
Participants assigned to the intervention group receive exercise prescriptions through a Telegram-based chatbot. In addition to delivering the exercise program, the chatbot provides instructional videos, automated reminders, exercise monitoring, adherence tracking, scheduling adjustments, and feedback based on participants' reported exercise completion. Participants allocated to the control group receive the same exercise program in a printed booklet together with a paper calendar for recording completed sessions. Both groups receive standardized follow-up telephone calls during the intervention period.
The primary outcome is exercise adherence, defined as the percentage of prescribed exercise sessions completed during the 12-week intervention. Participants are also classified according to whether they achieve at least 80% adherence to the prescribed sessions. Secondary outcomes include physical function assessed using the Short Physical Performance Battery (SPPB), 4-meter walking test, Five Times Sit-to-Stand Test (FTSST), and Timed Up and Go (TUG) test. Additional outcomes include physical activity measured with the International Physical Activity Questionnaire for Older Adults (IPAQ-E), participant satisfaction, perceived usability of the chatbot, and adverse events.
The study will provide evidence regarding the effectiveness of chatbot-supported exercise interventions for promoting adherence to home-based exercise programs among older adults. If effective, this approach may represent a scalable and accessible strategy to support healthy aging and the implementation of exercise programs in community settings.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Community-dwelling adults aged 60 years or older.
- Living independently in the community.
- Ownership and regular use of a smartphone.
- Familiarity with at least one instant messaging application and ability to access it at least three times per week.
- Ability to understand study procedures and instructions.
- Ability to provide written informed consent.
- Ability to safely perform a home-based exercise program.
Exclusion Criteria:
- Absolute contraindication to physical exercise.
- Inability to understand study instructions.
- Inability to read and/or write.
- Uncontrolled neurological conditions that may compromise safe participation in exercise.
- Uncontrolled cardiovascular conditions that may compromise safe participation in exercise.
- Any medical condition judged by the investigators to prevent safe participation in the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Chatbot-Supported Exercise Program
Participants will receive a 12-week home-based multicomponent exercise program delivered through a Telegram-based chatbot. The program includes three exercise sessions per week consisting of strength, balance, flexibility, and walking exercises with a predefined progression. The chatbot provides exercise prescriptions, instructional videos, reminders, monitoring of exercise completion, scheduling adjustments, and automated feedback to support adherence. |
A 12-week home-based multicomponent exercise program delivered through a Telegram-based chatbot. The program includes strength, balance, flexibility, and walking exercises performed three times per week. The chatbot provides exercise prescriptions, instructional videos, automated reminders, adherence monitoring, scheduling adjustments, and feedback to support exercise participation.
Ostatní jména:
|
|
Aktivní komparátor: Paper-Based Exercise Program
Participants will receive a 12-week home-based multicomponent exercise program in a printed booklet. The program includes three exercise sessions per week consisting of strength, balance, flexibility, and walking exercises with a predefined progression. Participants will also receive a paper calendar to record exercise completion. No chatbot-based reminders, monitoring, or automated feedback will be provided. Participants will receive the same exercise content, dosage, and progression as the experimental group. |
A 12-week home-based multicomponent exercise program delivered in a printed booklet. The program includes strength, balance, flexibility, and walking exercises performed three times per week with the same content and progression as the experimental intervention. Participants record exercise completion using a paper calendar and do not receive chatbot-based reminders, monitoring, or feedback. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Exercise Adherence
Časové okno: 12 weeks
|
Exercise adherence will be measured as the percentage of the 36 prescribed exercise sessions completed during the 12-week intervention period. Adherence will be calculated from participant exercise records and expressed as a continuous percentage value. |
12 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Adherent Participants
Časové okno: 12 weeks
|
Number and proportion of participants completing at least 80% of the prescribed exercise sessions during the intervention period. |
12 weeks
|
|
Short Physical Performance Battery (SPPB)
Časové okno: Baseline and 12 weeks
|
Physical function assessed using the Short Physical Performance Battery. Scores range from 0 to 12, with higher scores indicating better physical performance. |
Baseline and 12 weeks
|
|
Timed Up and Go Test (TUG)
Časové okno: Baseline and 12 weeks
|
Mobility assessed as the time required to stand up from a chair, walk 3 meters, turn, return, and sit down. |
Baseline and 12 weeks
|
|
Physical Activity Level
Časové okno: Baseline and 12 weeks
|
Physical activity will be assessed using the International Physical Activity Questionnaire for the Elderly (IPAQ-E). Physical activity is quantified as MET-minutes per week (MET-min/week), calculated from the frequency and duration of walking, moderate-intensity, and vigorous-intensity physical activities performed during the previous week. The questionnaire does not have a predefined minimum or maximum score, as results are reported as a continuous measure of energy expenditure. A practical minimum score is 0 MET-min/week, while no upper limit is defined. Higher scores indicate higher levels of physical activity and therefore a better outcome. |
Baseline and 12 weeks
|
|
Participant Satisfaction
Časové okno: 12 weeks
|
Participant satisfaction with the intervention will be assessed using the Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 consists of 8 items, each scored on a 4-point Likert scale. Total scores range from 8 to 32 points, with higher scores indicating greater satisfaction with the intervention and therefore a better outcome. |
12 weeks
|
|
Chatbot Usability
Časové okno: 12 weeks
|
Perceived usability of the chatbot will be assessed using the System Usability Scale (SUS). The SUS is a 10-item questionnaire with responses scored on a 5-point Likert scale. Total scores range from 0 to 100, with higher scores indicating better perceived usability of the chatbot and therefore a better outcome. This outcome will be assessed only in participants allocated to the chatbot intervention group. |
12 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- BOT_01
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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