Virtual Assistant for Exercise Adherence in Older ADULTS (AGE-BOT)

March 25, 2026 updated by: CARMEN GARCÍA GOMARIZ, University of Valencia

Application of a Virtual Assistant to Enhance Exercise Adherence in Older Adults

This study will evaluate the effectiveness of a virtual assistant-guided exercise program to improve adherence in older adults. In a nonrandomized controlled clinical trial, the experimental group will complete a 12-week, home-based program (60-minute sessions, 3 times per week) supported by a virtual assistant (BOT). The control group will comprise community-dwelling older adults already engaged in the municipal program Enguera se saludable, which delivers an in-person exercise program of comparable frequency and duration. The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed. Secondary outcomes include muscle strength, balance, functional capacity, health-related quality of life, and the user experience and usability of the virtual assistant.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to determine whether a virtual assistant-controlled, home-based exercise program can improve adherence to therapeutic exercise among older adults, compared with a conventional municipal program of similar dosage. Although exercise is effective for preserving function and quality of life during aging, adherence remains suboptimal. Virtual assistants may offer a scalable and acceptable solution to support sustained participation.

The study will employ a nonrandomized controlled clinical trial (quasi-experimental design) involving community-dwelling adults aged ≥60 years. Participants will be allocated to groups based on program pathway:

Experimental group (Virtual Assistant/BOT): a structured home-based exercise program (60 minutes per session, 3 sessions per week for 12 weeks), guided and monitored by a virtual assistant (BOT), including automated session delivery, reminders, and adherence tracking.

Control group (Municipal program): older adults already participating in Enguera se saludable, an onsite, instructor-led municipal program with equivalent frequency and duration (60 minutes, 3 times per week for 12 weeks). Attendance records from the municipal program will quantify adherence.

The primary outcome is exercise adherence, defined as the proportion of prescribed sessions completed during the 12-week period, with predefined adherence thresholds (e.g., ≥75% of sessions completed). Secondary outcomes include changes in muscle strength, balance, functional performance, and health-related quality of life. Additional measures will include user perceptions, usability, and satisfaction with the virtual assistant to evaluate acceptability and feasibility.

Given the nonrandomized design and the pre-existing enrollment of the control group, the study will incorporate the following methodological safeguards:

Baseline demographic and clinical characteristics (e.g., age, sex, comorbidities, prior activity level) will be comprehensively documented.

Baseline imbalances will be controlled through statistical adjustment (e.g., covariate adjustment, propensity score procedures, and sensitivity analyses) to reduce selection bias and confounding.

Exercise dosage (frequency, duration, and intervention length) will be matched across groups, or, when small discrepancies arise, dosage will be included as a covariate in the analyses.

This study is expected to contribute evidence regarding whether a virtual assistant-based exercise program represents a viable, effective, and acceptable alternative to conventional program delivery models for promoting active and healthy aging in community-dwelling older adults.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 60 years or older.
  • Community-dwelling individuals capable of participating in an exercise program.
  • Ability to complete 60-minute exercise sessions, three times per week during the 12-week intervention.
  • Experimental group (BOT Group): Participants willing to use a smartphone/tablet and interact with the virtual assistant.
  • Control group (Municipal Exercise Group): Individuals already enrolled in the municipal program Enguera se saludable.
  • Ability to understand the study procedures and provide written informed consent

Exclusion Criteria:

  • Medical contraindications to physical exercise, as determined by clinical judgment (e.g., uncontrolled cardiovascular, respiratory, or metabolic conditions).
  • Severe cognitive impairment or neurological conditions that limit the ability to follow instructions or safely perform the exercise program.
  • Severe mobility limitations preventing participation in structured exercise (e.g., inability to walk independently with or without aid).
  • Acute musculoskeletal injuries or recent surgeries that contraindicate exercise participation.
  • Individuals currently participating in another structured exercise program that would interfere with the study interventions (other than Enguera se saludable for the control group).
  • Inability or unwillingness to comply with the requirements of the study (frequency, duration, assessments).
  • For the BOT group: lack of access to a device compatible with the virtual assistant or inability/unwillingness to use it.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bot Group
Participants in this group will complete a 12-week home-based exercise program delivered and monitored by a virtual assistant (BOT). The program consists of 60-minute sessions, three times per week, including guided instructions, automated reminders, and adherence tracking. The BOT provides real-time session support and records participation throughout the intervention.
Procedure: Exercise program

BOT Group: Home-based exercise program delivered through a virtual assistant for 12 weeks (60 minutes, three times per week), including guided instructions and adherence monitoring.

Enguera Exercise Group: Face-to-face, instructor-led exercise sessions from the Enguera se saludable program, with the same frequency and duration (60 minutes, three times per week for 12 weeks).
Active Comparator: Enguera program Group
Participants in this group are individuals already enrolled in the municipal program "Enguera se saludable", which offers a face-to-face, instructor-led exercise program of the same duration and frequency (60 minutes, three times per week for 12 weeks). Attendance is recorded routinely by program instructors and will be used to assess adherence.
Procedure: Exercise program

BOT Group: Home-based exercise program delivered through a virtual assistant for 12 weeks (60 minutes, three times per week), including guided instructions and adherence monitoring.

Enguera Exercise Group: Face-to-face, instructor-led exercise sessions from the Enguera se saludable program, with the same frequency and duration (60 minutes, three times per week for 12 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exercise Adherence (% of prescribed sessions completed)
Time Frame: End of the 12-week intervention.

Exercise adherence will be defined as the percentage of prescribed exercise sessions completed during the 12-week intervention. A single adherence value will be calculated for each participant as:

\text{Adherence (%) = (Sessions completed / Sessions prescribed) × 100}

Measurement method:

Virtual Assistant/BOT Group: Adherence will be recorded automatically by the virtual assistant (BOT), which logs session completion in real time.

Municipal Exercise Group: Adherence will be calculated from attendance records routinely collected in the Enguera se saludable municipal program, using the same formula (completed / prescribed × 100).

Although adherence is obtained from different data sources, the measurement itself is identical in both groups, expressed as a percentage (%).
End of the 12-week intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical performance assessed by the Short Physical Performance Battery (SPPB)
Time Frame: Baseline and 12 weeks.

Lower-limb functional performance will be assessed using the Short Physical Performance Battery (SPPB), a validated instrument for older adults. The SPPB includes three components: balance tests, gait speed, and the 5-times sit-to-stand test. Each component is scored from 0 to 4, yielding a total score from 0 to 12, with higher scores indicating better physical performance.

Unit of measurement:

SPPB total score (0-12 points).
Baseline and 12 weeks.
Accelerometry-Based Physical Activity (Moderate-to-Vigorous Activity Levels)
Time Frame: Baseline and 12 weeks

Moderate-to-vigorous physical activity (MVPA) will be quantified using a wrist- or hip-worn triaxial accelerometer. MVPA will be calculated according to established cut-points for older adults, expressed as minutes per day accumulated at moderate or vigorous intensity. Devices will be worn during the monitoring period, and raw acceleration data will be processed using standardized algorithms to derive daily MVPA time. A single MVPA value will be generated for each assessment period.

Unit of measurement:

Minutes/day of MVPA (moderate-to-vigorous physical activity).
Baseline and 12 weeks
Risk of falls measured by the FallSkip® system (Fall Risk Index, 0-100)
Time Frame: Baseline and 12 weeks

Risk of falls will be assessed using the FallSkip® system, an instrumented device that evaluates fall risk in older adults through a standardized functional protocol. The device records parameters such as reaction time, postural stability, gait acceleration/deceleration patterns, and sit-to-stand performance. These variables are integrated automatically by the device software to generate a Fall Risk Index on a 0-100 scale, with higher values indicating greater risk of falls. A single Fall Risk Index score will be obtained for each participant at every assessment time point.

Unit of measurement:

FallSkip® Fall Risk Index (0-100 points).
Baseline and 12 weeks
User experience and usability of the virtual assistant measured with a Visual Analog Scale (VAS)
Time Frame: 12 weeks.

User experience and usability of the virtual assistant (BOT) will be evaluated using a Visual Analog Scale (VAS), an anchored numerical scale ranging from 0 to 10, in which 0 represents the worst possible user experience/usability and 10 represents the best possible user experience/usability. Participants will rate their overall experience and perceived usability of the virtual assistant on this single-item scale. A single VAS score will be obtained for each assessment period.

Unit of measurement:

Score on the Visual Analog Scale (0-10), where higher scores indicate better user experience/usability.
12 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Valencia

Collaborators

Generalitat Valenciana

Investigators

  • Principal Investigator: CARMEN GARCÍA GOMARIZ, Phd, UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 20, 2026

First Submitted That Met QC Criteria

March 25, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESS_BOT01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Exercise

Clinical Trials on Exercise program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe