Virtual Assistant for Exercise Adherence in Older ADULTS

NCT07498530 | Recruiting

• 1 other identifier: ESS_BOT01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Older Adult; Exercise; Adherence; Prevention; New Technologies

Outcome Measures

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 (%).

  End of the 12-week intervention.

Secondary Outcomes (4)

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

  Baseline and 12 weeks.

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

  Baseline and 12 weeks

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

  Baseline and 12 weeks

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

  12 weeks.

Study Arms (2)

Bot Group

EXPERIMENTAL

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

Enguera program Group

ACTIVE COMPARATOR

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

Interventions

Exercise program PROCEDURE

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).

Bot Group; Enguera program Group

Eligibility Criteria

• Age: 59 Years+
• Gender Eligibility Details: All genders are eligible. Eligibility is based on age (≥60 years) and clinical criteria, not on sex assigned at birth or gender identity. Gender will be self-reported for descriptive and subgroup analyses (options: woman, man, non-binary, another identity, prefer not to say).
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Valencia: lead
• Generalitat Valenciana: collaborator

Study Sites (1)

Carmen García Gomariz

Valencia, 46010, Spain

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• CARMEN GARCÍA GOMARIZ, Phd

  UNIVERSITAT DE VALÉNCIA DEPARTAMENTO D'INFERMERIA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CARMEN GARCÍA GOMARIZ, Phd

CONTACT

963983853; Carmen.garcia-gomariz@uv.es

José M Blasco, Catedratic

CONTACT

637787861; Jose.Maria.Blasco@uv.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and data analysts will be blinded to group allocation to prevent assessment and analysis bias, while participants and exercise instructors will remain unblinded due to the nature of the interventions.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: Nonrandomized controlled clinical trial comparing a virtual assistant-guided home-based exercise program with the existing municipal program Enguera se saludable to evaluate adherence and health outcomes in older adults.

Study Record Dates

• First Submitted: March 20, 2026
• First Posted: March 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)