Frailty at Older AdultsMOTIVANCT07447453
Motivational Support for an Autonomous Exercise Program for Healthy Aging
A study testing MOTIVA ecosystem in people with Frailty at Older Adults, run by Hospital Universitario Getafe at 2 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty at Older Adults
- What is being tested?
- MOTIVA ecosystem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 2 sitesSpain
- Study dates
- 8 Apr 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 70 years of age or older.
- Obtain a score of 4 or higher on the SPPB.
- Be able to ambulate, with or without assistance.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Universitario Getafe
Getafe, Madrid, 28905
Primary Care
Madrid, Madrid, 28041
About this study
Official title: 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.
- Conditions
- Frailty at Older Adults
- Being tested
- MOTIVA ecosystem
- Keywords
- Frailty, Clinical trial, Motivational profile
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MOTIVA ecosystemOther
A personalized exercise plan based on the user's motivational profile and performance, without professional supervision or a caregiver.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MOTIVA ecosystem |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to the end of treatment at 12 months
Secondary outcomes (3)
SPPB (The Short Physical Performance Battery)
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.
Measured: From enrollment to the end of treatment at 12 months
global assement
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
Measured: From enrollment to the end of treatment at 12 months
Digital assement
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.
Measured: From enrollment to the end of treatment at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start8 Apr 2025
- Primary completion31 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty at Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- None-Drug randomized clinical trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Getafe
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Politecnica de Madrid
- Responsible party
- Sponsor
- Investigators
- Olga Laosa Zafra, MD. PhD, Principal investigator, Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447453
- Sponsor's protocol ID
- MOTIVA
- Acronym
- MOTIVA
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is necessary to consult it with the entire consortium.
Publications
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.
PubMed 32234291
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computational Ecosystem With Motivational Support and Functional Assessment for an Autonomous Exercise Program Promoting Healthy Aging (MOTIVA)
- ClinicalTrials.gov ID
- NCT07447453
- Acronym / sponsor ID
- MOTIVA / MOTIVA
- Conditions
- Frailty at Older Adults
- Keywords
- Frailty, Clinical trial, Motivational profile
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Hospital Universitario GetafeUniversity, hospital or other
- Collaborators
- Universidad Politecnica de Madrid
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- None-Drug randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –VIVIFRAIL Application + ecosystem MOTIVA +NONE motivational support. |
| intervention arm | Experimental | Other: MOTIVA ecosystemVIVIFRAIL Application + ecosystem MOTIVA + A personalized exercise monitoring and encouragement plan based on the user's motivational profile. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 70 years of age or older.
- Obtain a score of 4 or higher on the SPPB.
- Be able to ambulate, with or without assistance.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MOTIVA ecosystemA personalized exercise plan based on the user's motivational profile and performance, without professional supervision or a caregiver. | Other | intervention arm |
Primary outcome
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
3 secondary outcomes
SPPB (The Short Physical Performance Battery)
Time frame: From enrollment to the end of treatment at 12 months
global assement
Time frame: From enrollment to the end of treatment at 12 months
Digital assement
Time frame: From enrollment to the end of treatment at 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Background: PubMed 32234291Angulo 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.
- VIVIFRAIL: multicomponent exercise programLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is necessary to consult it with the entire consortium.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olga Laosa Zafra, MD. PhD principal investigator
Fundación para la Investigación Biomédica - Hospital Universitario de Getafe
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MOTIVA ecosystem in people with Frailty at Older Adults, run by Hospital Universitario Getafe at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MOTIVA Ecosystem (time frame: From enrollment to the end of treatment at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07447453, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.