NCT07447453

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Apr 2025Jul 2026

Study Start

First participant enrolled

April 8, 2025

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 13, 2026

Completed
18 days until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

February 13, 2026

Last Update Submit

February 26, 2026

Conditions

Frailty at Older Adults

Keywords

FrailtyClinical trialMotivational profile

Outcome Measures

Primary Outcomes (1)

  • MOTIVA Ecosystem

    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 Outcomes (3)

  • SPPB (The Short Physical Performance Battery)

    From enrollment to the end of treatment at 12 months

  • global assement

    From enrollment to the end of treatment at 12 months

  • Digital assement

    From enrollment to the end of treatment at 12 months

Study Arms (2)

Control group

NO INTERVENTION

VIVIFRAIL Application + ecosystem MOTIVA +NONE motivational support.

intervention arm

EXPERIMENTAL

VIVIFRAIL Application + ecosystem MOTIVA + A personalized exercise monitoring and encouragement plan based on the user's motivational profile.

Other: MOTIVA ecosystem

Interventions

MOTIVA ecosystemOTHER

A personalized exercise plan based on the user's motivational profile and performance, without professional supervision or a caregiver.

intervention arm

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Universitario Getafe

Getafe, Madrid, 28905, Spain

RECRUITING

Primary Care

Madrid, Madrid, 28041, Spain

RECRUITING

Related Publications (1)

  • Angulo J, El Assar M, Alvarez-Bustos A, Rodriguez-Manas L. Physical activity and exercise: Strategies to manage frailty. Redox Biol. 2020 Aug;35:101513. doi: 10.1016/j.redox.2020.101513. Epub 2020 Mar 20.

    PMID: 32234291BACKGROUND

Related Links

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Olga Laosa Zafra, MD. PhD

    Fundación para la Investigación Biomédica - Hospital Universitario de Getafe

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Olga Laosa Zafra, MD. PhD

CONTACT

+34916839360olga.laosa@salud.madrid.org

Elena Villalba Mora, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: None-Drug randomized clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2026

First Posted

March 3, 2026

Study Start

April 8, 2025

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations

ES(2)