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FrailtyFRAIL-LalinNCT07848802

Physical Function and Fall Risk in Older Adults in the Lalín Frailty Prevention Program

An observational study of Frailty and Fall Risk, Fall Prevention, run by University of Vigo at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This prospective observational study will describe changes in physical function and fall risk among adults aged 70 years or older who participate in the routine Frailty and Falls Prevention Program at the Centro Integral de Saúde de Lalín. Read more about this study

Who is it for?
Ages 70 years and older
Conditions the study is for
Frailty, Fall Risk, Fall Prevention
How many people
56 participants
Where
1 siteSpain
Study dates
15 Sep 2026to 15 Feb 2027
Phase
Observational
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
  • No healthy volunteers
  • Older adult

Study population: Adults aged 70 years or older linked to the Centro Integral de Saúde de Lalín who enter its routine Frailty and Falls Prevention Program through usual care and can provide informed consent.

Who may be able to join

  • Age ≥70 years; Barthel Index ≥90; inclusion in the Lalín Frailty and Falls Prevention Program; ability to understand study information and give informed consent.

Who cannot join

  • Medical contraindication to physical activity; inability to consent to study participation.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lorenzo Antonio Justo Cousiño, PhD contact

+34 986 801 758

lorenzo.justo@uvigo.gal

Eva Villar Díaz contact

+34 986 787 093

Eva.Villar.Diaz@sergas.es

Spain1 site, 1 recruiting

  • Centro Integral de Saúde de Lalín

    Lalín, Pontevedra, 36500

    Eva Villar Díaz, Bachelor's Degree in Physiothy, +34 986 787 093, Eva.Villar.Diaz@sergas.es

    Lorenzo Antotnio Justo Cousiño, PT, PhD, +34 986 801 758, lorenzo.justo@uvigo.gal

    Recruiting

Other trials in Spain

About this study

Official title: Observational Study of Frailty and Fall Risk in Older Adults Included in the Frailty and Falls Prevention Program at the Centro Integral de Saúde de Lalín

This prospective observational study will describe changes in physical function and fall risk among adults aged 70 years or older who participate in the routine Frailty and Falls Prevention Program at the Centro Integral de Saúde de Lalín. Clinical assessments obtained before the program (T0) and at its completion (T1, approximately 8-12 weeks later) will be analyzed. The study does not assign treatment or change routine care.

Read the detailed description

Participants referred to the routine primary care physiotherapy program will be invited to provide written informed consent for the use of their clinical assessment data. The care program comprises 12 supervised weekly multicomponent exercise sessions, with individualized progression and home aerobic exercise advice. It includes strength, aerobic, flexibility, balance and functional exercises, and dual tasks. Physiotherapists will record baseline and end-of-program measures, attendance and care-related adverse events. The principal objective is to describe changes in Short Physical Performance Battery (SPPB) score and fall-risk indicators. Secondary objectives are to characterize the population, examine the association of attendance with functional change, and describe adverse events. The study is longitudinal and prospective, with within-person pre/post comparisons; exercise is delivered as routine care and is not assigned by the investigators for research. The target enrollment is 56, allowing for up to 15% loss from 47 evaluable participants calculated for the SPPB endpoint. No extra instrumented tests or procedures outside the described care are added for research.

Keywords
Older Adults, Physical Function, Falls Prevention, Short Physical Performance Battery, Primary Care Physiotherapy, Multicomponent Exercise
Medical subject headings
Frailty

What participants receive

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

Study groups in NCT07848802
Study groupRoleWhat they receive
Participants in the Lalín Frailty and Falls Prevention Program: adults aged 70 years or older with BRoutine multicomponent therapeutic exercise program; 12 supervised sessions, one per week, with individualized progression. Strength, aerobic, flexibility, balance, functional and dual-task components are described in the care protocol. Home aerobic activity is advised by the treating physiotherapist.

What is being measured

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

  1. Change in Short Physical Performance Battery (SPPB) Total Score

    Change in SPPB total score, a composite measure of lower-extremity function comprising standing balance, gait speed and chair rise. Score range: 0-12 points. Higher scores indicate better physical performance. Unit: points.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  2. Change in Fall Risk Indicators

    Change in the three protocol-defined yes/no indicators: a fall in the preceding year requiring healthcare, two or more falls in the preceding year, and clinically relevant gait impairment. Each indicator is recorded as No or Yes; no composite score or fixed numerical range is specified. A Yes response indicates the corresponding risk feature.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks); each assessment uses the protocol-defined recall or clinical assessment.

Secondary outcomes (12)

  1. Change in Timed Up and Go Test Time

    Time to stand, walk, turn, return and sit, recorded in seconds. Lower values indicate better mobility. Minimum: 0 seconds; no fixed maximum is specified in the protocol. The test is described as an alternative screening test in Section 4.4 and as a T0/T1 measure in the data collection form.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  2. Change in FRAIL Scale Total Score

    Change in FRAIL questionnaire total score. Score range: 0-5 points; higher scores indicate greater frailty. FRAIL Scale total score. The score ranges from 0 to 5 points, with higher scores indicating greater frailty. Unit: points.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  3. Change in Number of Chronic Prescription Medications

    Number of medicines prescribed chronically at each assessment. Unit: medication count; minimum 0, with no fixed maximum. Higher values indicate more chronic prescribed medicines, not necessarily a better or worse clinical outcome.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  4. Change in 4 Meter Gait Speed

    Usual gait speed over 4 meters, expressed in meters per second. Minimum 0 m/s; no fixed maximum is specified. Higher values indicate faster walking.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  5. Change in 6 Minute Walk Test Performance

    Performance on the 6-minute walk test. Total distance walked during the 6-Minute Walk Test. Unit: meters (m). Minimum possible value is 0 m; no fixed maximum is specified. Higher values indicate greater functional walking capacity.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks), when the 6-minute walk test is feasible.

  6. Change in 2 Minute Step Test Performance

    Performance on the 2-minute step test, used when the 6-minute walk test is not feasible because of insufficient space. Number of correctly completed steps during the 2-Minute Step Test. A step is counted when the designated knee reaches the target height defined midway between the patella and iliac crest. Unit: steps. Minimum possible value is 0 steps; no fixed maximum is specified. Higher values indicate greater aerobic endurance.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks), when the 6-minute walk test is not feasible.

  7. Change in Arm Curl Test Performance

    Performance on the arm curl test. Number of correctly completed arm-curl repetitions in 30 seconds using the protocol-defined external load. Unit: repetitions. Minimum possible value is 0 repetitions; no fixed maximum is specified. Higher values indicate greater upper-extremity functional strength/endurance.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  8. Change in Functional Reach Test Performance

    Performance on the Functional Reach Test. Maximum forward reach distance achieved while maintaining a fixed base of support during the Functional Reach Test. Unit: centimeters (cm). Higher values indicate greater functional reach and dynamic balance ability.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  9. Change in Unipedal Stand Test Performance

    Performance on the Unipedal Stand Test. Duration for which the participant maintains unipedal stance without external support with open eyes. Unit: seconds. Higher values indicate better static balance.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  10. Change in Chair Sit and Reach Test Performance

    Performance on the Chair Sit and Reach Test. Distance between the fingertips and the toes during the Chair Sit-and-Reach Test. Unit: centimeters (cm). A score of 0 cm indicates that the fingertips reach the toes; negative values indicate that the fingertips fall short of the toes, and positive values indicate that the fingertips extend beyond the toes. Higher values indicate greater lower-extremity flexibility.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  11. Change in Back Scratch Test Performance

    Performance on the Back Scratch Test. Distance between the middle fingertips during the Back Scratch Test. Unit: centimeters (cm). A score of 0 cm indicates that the fingertips touch; negative values indicate a gap between the fingertips, and positive values indicate overlap. Higher values indicate greater upper-body flexibility.

    Measured: Baseline (T0) and end of the care program (T1, 8-12 weeks).

  12. Program Attendance

    Number of supervised sessions attended out of 12 scheduled sessions; range 0-12 sessions. Higher values indicate greater attendance.

    Measured: Throughout the care program, from T0 to T1 (approximately 8-12 weeks).

Timeline

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

  1. First posted30 Sep 2026
  2. Study start15 Sep 2026
  3. Primary completion15 Jan 2027 (estimated)
  4. Study completion15 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
56 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07848802
Sponsor's protocol ID
2026/386
Acronym
FRAIL-Lalin
Status last verified
Sep 2026
First submitted
23 Sep 2026
Last updated
30 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The research team is currently evaluating the possibility of sharing the data in accordance with the approved Ethics Committee protocol. According to the approval of the Ethics Committee and the informed consent document for participation in the research study, upon completion of the study, participants may choose whether their data should be deleted or retained in anonymized form for future research purposes. The possibility of sharing the data will therefore depend on each participant's choice. For participants who request deletion of their data, all corresponding data will be permanently destroyed once the study has been completed. Conversely, for participants who consent to the retention of their anonymized data for future research, the possibility of sharing the available anonymized data for subsequent research purposes may be considered, in accordance with the applicable ethical and regulatory requirements.

Publications

  • Mehta P, Costa EC, Galliano LM, Vlietstra L, Saragiotto BT, Cadore EL, Izquierdo M, Waters DL. Exercise to prevent falls in older adults with physical frailty: A systematic review and meta-analysis. J Frailty Aging. 2026 Aug;15(4):100187. doi: 10.1016/j.tjfa.2026.100187. Epub 2026 Aug 18.

    PubMed 42611710

  • Pradana AA, Hidayat AT, Yanti L, Lee SC. Effect of Physical Exercise on Frailty in Older Nursing Home Residents: A Systematic Review and Meta-Analysis. J Am Geriatr Soc. 2026 May;74(5):1450-1463. doi: 10.1111/jgs.70330. Epub 2026 Feb 3.

    PubMed 41631861

  • Abizanda Saro A, Garcia Molina R, Alcantud Corcoles R, Maestre Moreno M, Sanchez Uceda R, Moron Merchante I, Aragones Jimenez A, Gonzalez Cespedes MD, Montero Alia P, Simarro Rueda M, Torres Anton L, Martinez Garcia P, Soriano Fernandez H, Corcoles Garcia M, Reyes Abreu AM, Morcillo Gonzalez MN, Garcia Paez E, Rodriguez Sanchez B, Saez Blesa M, Cortes Zamora EB, Andres Pretel F, Avendano Cespedes A; FRAILMERIT Study Group; Abizanda P. Efficacy of a Multicomponent Intervention for Frailty or Physical Function in Prefrail or Frail Older Adults: FRAILMERIT Multicenter Clinical Trial. J Am Geriatr Soc. 2026 Mar;74(3):658-668. doi: 10.1111/jgs.70266. Epub 2025 Dec 28.

    PubMed 41456342

  • Chen X, Ma C, Zhao L, Zhang H, Yang X. Effects of the Otago Exercise Program on frailty and cognitive function in cognitively frail older adults in nursing homes: A randomized controlled trial. Appl Nurs Res. 2026 Aug;90:152107. doi: 10.1016/j.apnr.2026.152107. Epub 2026 Jun 10.

    PubMed 42547134

  • Vieira LM, Bocalini DS, Dos Santos CPC, Rego LB, Villar R, Junior AJF, da Silva RC, de Souza Lima AP, Netto RBMC, Neto FS, Nonato TC, Pinto JP, Junior FLP. Effect of bodyweight interval training on frailty status in older adults: a randomized controlled trial. Eur Geriatr Med. 2026 Aug 12. doi: 10.1007/s41999-026-01579-8. Online ahead of print.

    PubMed 42584791

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PubMed 23395245

  • Brar S, Hopkins M, Margolius D. Time to Next Available Appointment as an Access to Care Metric. Jt Comm J Qual Patient Saf. 2019 Nov;45(11):779-780. doi: 10.1016/j.jcjq.2019.07.007. Epub 2019 Aug 29. No abstract available.

    PubMed 31474517

  • Morley JE, Vellas B, van Kan GA, Anker SD, Bauer JM, Bernabei R, Cesari M, Chumlea WC, Doehner W, Evans J, Fried LP, Guralnik JM, Katz PR, Malmstrom TK, McCarter RJ, Gutierrez Robledo LM, Rockwood K, von Haehling S, Vandewoude MF, Walston J. Frailty consensus: a call to action. J Am Med Dir Assoc. 2013 Jun;14(6):392-7. doi: 10.1016/j.jamda.2013.03.022.

    PubMed 23764209

  • Perera S, Mody SH, Woodman RC, Studenski SA. Meaningful change and responsiveness in common physical performance measures in older adults. J Am Geriatr Soc. 2006 May;54(5):743-9. doi: 10.1111/j.1532-5415.2006.00701.x.

    PubMed 16696738

  • Pilotto A, Custodero C, Maggi S, Polidori MC, Veronese N, Ferrucci L. A multidimensional approach to frailty in older people. Ageing Res Rev. 2020 Jul;60:101047. doi: 10.1016/j.arr.2020.101047. Epub 2020 Mar 21.

    PubMed 32171786

  • Proietti M, Cesari M. Frailty: What Is It? Adv Exp Med Biol. 2020;1216:1-7. doi: 10.1007/978-3-030-33330-0_1.

    PubMed 31894541

  • Deng Y, Zhang K, Zhu J, Hu X, Liao R. Healthy aging, early screening, and interventions for frailty in the elderly. Biosci Trends. 2023 Sep 15;17(4):252-261. doi: 10.5582/bst.2023.01204. Epub 2023 Aug 23.

    PubMed 37612123

  • Hoogendijk EO, Afilalo J, Ensrud KE, Kowal P, Onder G, Fried LP. Frailty: implications for clinical practice and public health. Lancet. 2019 Oct 12;394(10206):1365-1375. doi: 10.1016/S0140-6736(19)31786-6.

    PubMed 31609228

  • Lee H, Lee E, Jang IY. Frailty and Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e16. doi: 10.3346/jkms.2020.35.e16.

    PubMed 31950775

  • Kim KJ, Lee SB, Kim CO. How to Assess Frailty: Role of Comprehensive Geriatric Assessment. J Korean Med Sci. 2020 Jan 20;35(3):e34. doi: 10.3346/jkms.2020.35.e34. No abstract available.

    PubMed 31950780

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Fall Risk, Fall Prevention, run by University of Vigo 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 30 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 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?

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?

Contact Lorenzo Antonio Justo Cousiño, PhD (+34 986 801 758, lorenzo.justo@uvigo.gal), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Short Physical Performance Battery (SPPB) Total Score (time frame: Baseline (T0) and end of the care program (T1, 8-12 weeks).). 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 NCT07848802, which also lists 28 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 30 Sep 2026.

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