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FrailtyFRAGSALUDNCT05610605

Education for Prevention and Treatment of Frailty

A study testing Health intervention programme: FRAGSALUD in people with Frailty and Frail Elderly Syndrome, run by University of Cadiz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. The aging of the population in Spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy… Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Frailty, Frail Elderly Syndrome
What is being tested?
Health intervention programme: FRAGSALUD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
235 participants
Where
1 siteSpain
Study dates
30 Mar 2022to 30 Sep 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Patients over 65 years of age who present frailty or pre-frailty, assessed using the Fried criteria adapted to Spanish population;
  • Patients belonging to Clinical Management Units participating in the study and who will remain in it for the 15 months of the study;
  • Patients who can come to the Health Center alone or accompanied.

Who cannot join

  • Patients with no full control of their capabilities.
  • Patients who do not understand Spanish;
  • Patients with allergies to plastic or metal.
  • Patients who are instutionalized.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Faculty of Education

    Puerto Real, Cádiz, 11519

Other trials in Spain

About this study

Official title: Randomized Clinical Trial to Assess the Efficacy of an Educational Programme for Prevention and Treatment of Frailty in Older Adults Living in the Community: FRAGSALUD Programme

Frailty is a condition with a high prevalence in older adults, leading to higher vulnerability and increasing the risk of adverse health outcomes and disabilities. The aging of the population in Spain is accelerating quickly, consequently, it is necessary to advise the population on the appropriate path to healthy aging, free of fragility and their secondary problems.

Read the detailed description

To evaluate the efficacy and efficiency of a Fragsalud program for the prevention and multifactorial treatment of frailty in people over 65 years of age living in the community compared to the usual treatment. Material and methods: A Single blind randomized, two-arm clinical trial; control group and intervention group, multicenter, with 15 months of follow-up, with evaluations blinded at the beginning, and in the follow-up at 12 and 15 months. A recruitment of 196 people over 65 years of age with criteria of pre-frailty or frailty according to Fried's criteria. The Fragsalud education program will be taught in the intervention group; while control group will follow the usual health care. The evolution of the criteria of frailty, cognitive state, eating pattern, emotional state, quality of sleep, perceived social support, quality of life, functional capacity in daily life, adverse results, assessment of self-efficacy and cost-utility analysis variables will be evaluated. Possible confounding factors such as sociodemographic variables, comorbidity and polymedication will be controlled. Intention-to-treat analysis will be performed.

Being tested
Health intervention programme: FRAGSALUD
Keywords
Elderly Persons, Aging, Cost-Efficiency Analysis, Health Education
Medical subject headings
Frailty, Health Education

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health intervention programme: FRAGSALUDOther

    The FRAGSALUD Program consists in two parts, a first part of health education that will be taught in a group in four sessions, and a second part of individual treatment and follow-up, individual consultations will have a bimonthly periodicity until reaching one year, at which time that the program ends and a final evaluation will be carried out to assess whether the changes are maintained 15 months after the start.

Study groups in NCT05610605
Study groupRoleWhat they receive
Control GroupNo interventionParticipants who do not receive attention from the Fragsalud program. The control group follows the usual care and preventive measures in Primary Care, according to different protocols implemented and the criteria of nurses and family doctors responsible for their care.
Intervention GroupExperimentalThe FRAGSALUD Programme is a multidomain intervention programme, which covers the prevention and treatment of frailty from different aspects, fundamentally from a physical and cognitive aspect and to maintain social integration, although other modifiable factors that are related to the presence of fragility such as hearing impairment, visual deficit or depression.
Receives: Other: Health intervention programme: FRAGSALUD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months

    Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity).

    A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty).

    0 = Robust (non-frail)

    1-2 = Pre-frail

    3-5 = Frail

    Measured: Preintervention/Postintervention (0 and 6 months)

  2. Evaluation of the Change of Baseline Fried Frailty Criteria at 12 Months

    Assessment of frailty using the Fried Frailty Phenotype. This is a five-component measure used to classify frailty status (unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity).

    A score of 1 is assigned for each criterion met, yielding a total score that ranges from 0 to 5. A higher score indicates a worse outcome (greater frailty).

    0 = Robust (non-frail)

    1-2 = Pre-frail

    3-5 = Frail

    Measured: Preintervention/Retest (0 and 12 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2022
  2. Study start30 Mar 2022
  3. Primary completion1 Sep 2023
  4. Study completion30 Sep 2023

Resources

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
Masking
None (open label)
Enrolment
235 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05610605
Sponsor's protocol ID
FRAGSALUD
Acronym
FRAGSALUD
Status last verified
Feb 2022
First submitted
9 Feb 2022
Last updated
2 Dec 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Costilla M, Corral-Perez J, Vazquez-Sanchez MA, Avila-Cabeza-de-Vaca L, Gonzalez-Mariscal A, Casals C. Improvements in Depressive Symptoms, Perceived Social Support, and Quality of Life Through an Educational Program in Community-Dwelling Older Adults With Frailty Phenotype: A Randomized Controlled Trial of the FRAGSALUD Project. Am J Geriatr Psychiatry. 2025 Aug;33(8):877-890. doi: 10.1016/j.jagp.2025.02.014. Epub 2025 Mar 1.

    PubMed 40121126

  • Gonzalez-Mariscal A, Corral-Perez J, Vazquez-Sanchez MA, Avila-Cabeza-de-Vaca L, Costilla M, Casals C. Benefits of an educational intervention on functional capacity in community-dwelling older adults with frailty phenotype: A randomized controlled trial. Int J Nurs Stud. 2025 Feb;162:104955. doi: 10.1016/j.ijnurstu.2024.104955. Epub 2024 Nov 9.

    PubMed 39579605

  • Corral-Perez J, Vazquez-Sanchez MA, Casals-Sanchez JL, Contreras-Garcia FJ, Costilla M, Casals C. A 6-month educational program improves sleep behaviour in community-dwelling frail older adults: A randomised controlled trial. Sleep Med. 2024 Sep;121:196-202. doi: 10.1016/j.sleep.2024.07.011. Epub 2024 Jul 10.

    PubMed 39002328

  • Casals C, Corral-Perez J, Avila-Cabeza-de-Vaca L, Gonzalez-Mariscal A, Carrion-Velasco Y, Rodriguez-Martinez MC, Jimenez-Cebrian AM, Vazquez-Sanchez MA. Exploring the interplay of frailty, physical function, physical activity, nutritional status, and their association with quality of life and depressive symptoms in older adults with the frailty phenotype. Int J Geriatr Psychiatry. 2024 Mar;39(3):e6078. doi: 10.1002/gps.6078.

    PubMed 38470426

  • Corral-Perez J, Casals C, Avila-Cabeza-de-Vaca L, Gonzalez-Mariscal A, Mier A, Espinar-Toledo M, Garcia-Agua Soler N, Vazquez-Sanchez MA. Associations Between Physical Activity and Inactivity Levels on Physical Function and Sleep Parameters of Older Adults With Frailty Phenotype. J Appl Gerontol. 2024 Jul;43(7):910-921. doi: 10.1177/07334648231218095. Epub 2023 Dec 1.

    PubMed 38038169

Questions about this trial

What is this clinical trial studying?

A study testing Health intervention programme: FRAGSALUD in people with Frailty and Frail Elderly Syndrome, run by University of Cadiz at 1 site 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 4 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 2 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Evaluation of the Change of Baseline Fried Frailty Criteria at 6 Months (time frame: Preintervention/Postintervention (0 and 6 months)). The study lists 2 primary outcomes in all. 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 NCT05610605, which also lists 5 linked publications.

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 2 Dec 2025.

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