Motivational Support for an Autonomous Exercise Program for Healthy Aging (MOTIVA)

February 26, 2026 updated by: Hospital Universitario Getafe

Computational Ecosystem With Motivational Support and Functional Assessment for an Autonomous Exercise Program Promoting Healthy Aging (MOTIVA)

An effective implementation of an exercise programme such as VIVIFRAIL, in an unsupervised mode, requires a careful consideration of the patient's motivational traits and state, and the adaptation of the interventions to the current stage in the behaviour change process, as critical countermeasures to fight against abandonment and lack of compliance. A computational ecosystem with motivational support, and functional and performance assessment for an autonomous exercise programme will improve the robust and prefrail community-dwelling older adults' independence and their physical and cognitive health, while reducing healthcare utilisation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

190

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

  • Name: Elena Villalba Mora, PhD

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 70 years of age or older.
  • Obtain a score of 4 or higher on the SPPB.
  • Be able to ambulate, with or without assistance.

Exclusion Criteria:

  • Be unable to give consent or refuse to do so.
  • Be unable to understand the instructions.
  • Have a diagnosis of a disease or clinical condition that, in the researcher's judgment, contraindicates physical exercise.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
VIVIFRAIL Application + ecosystem MOTIVA +NONE motivational support.
Experimental: intervention arm
VIVIFRAIL Application + ecosystem MOTIVA + A personalized exercise monitoring and encouragement plan based on the user's motivational profile.
Other: MOTIVA ecosystem
A personalized exercise plan based on the user's motivational profile and performance, without professional supervision or a caregiver.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MOTIVA Ecosystem
Time Frame: From enrollment to the end of treatment at 12 months
Compare the number of exercises performed (#exercises per session) in each VIVIFRAIL program session to the total number of sessions (adherence) between the control and intervention groups
From enrollment to the end of treatment at 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPPB (The Short Physical Performance Battery)
Time Frame: From enrollment to the end of treatment at 12 months
Assess the functional status of participants (Score of SPPB scale) 0-4 points: Severe limitation of mobility. 4-6 points: Moderate limitation. 7-9 points: Mild limitation. 10-12 points: Minimal limitation.
From enrollment to the end of treatment at 12 months
global assement
Time Frame: From enrollment to the end of treatment at 12 months
Assess the physical (SPPB test, EUROQL5d score, Lawton score, fall/ last 6 months), emotional health (Yesavage Questionnaire) of participants, before and after enrollment in the study
From enrollment to the end of treatment at 12 months
Digital assement
Time Frame: From enrollment to the end of treatment at 12 months

Describe whether or not there has been an improvement in the digital skills of our older adults by:

1- Score of usability > 80.3: A (Excellent). Users love the system and will recommend it. 68 - 80: B/C (Good/Acceptable). The system is usable, but there is room for improvement.

51 - 67: D (Poor/Acceptable). The system has significant usability problems. < 50: F (Unacceptable). The system is very difficult to use.

2-Score of UEQ test Between -0.8 and 0.8: Considered neutral (average). Scores > 0.8: Positive. Scores > 1.5: Excellent.
From enrollment to the end of treatment at 12 months

Collaborators and Investigators

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

Sponsor

Hospital Universitario Getafe

Collaborators

Universidad Politecnica de Madrid

Investigators

  • Principal Investigator: Olga Laosa Zafra, MD. PhD, Fundación para la Investigación Biomédica - Hospital Universitario de Getafe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

April 8, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

February 13, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 3, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOTIVA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

It is necessary to consult it with the entire consortium.

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.

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