Virtual Assistant for Exercise Adherence in Older ADULTS

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age59+
SponsorUniversity of Valencia

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise program

    Procedure/Surgery

    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).

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Bot GroupExperimental treatment 1 intervention
Group B: Enguera program GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Exercise Adherence (% of prescribed sessions completed)

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 (%).

Time frame
End of the 12-week intervention.

Secondary outcomes

1

Physical performance assessed by the Short Physical Performance Battery (SPPB)

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).

Time frame
Baseline and 12 weeks.
2

Accelerometry-Based Physical Activity (Moderate-to-Vigorous Activity Levels)

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).

Time frame
Baseline and 12 weeks
3

Risk of falls measured by the FallSkip® system (Fall Risk Index, 0-100)

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).

Time frame
Baseline and 12 weeks
4

User experience and usability of the virtual assistant measured with a Visual Analog Scale (VAS)

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.

Time frame
12 weeks.

Other outcomes

Sponsors and contacts

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University of Valencia

Lead sponsor

Generalitat Valenciana

Collaborator