Clinical Efficacy of a Multicomponent Exercise and Comprehensive Geriatric Assessment Program (FRAIL+AP) in Frail Older Adults Within Primary Care: A Randomized Controlled Trial

NCT07643064 | Recruiting

• 2 other identifiers: CHUC_2026_19PIFIISC 25/28
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is a multidimensional clinical syndrome associated with increased vulnerability to adverse health outcomes in older adults. Despite strong evidence supporting multicomponent exercise interventions, their implementation in primary care settings remains limited. This randomized controlled trial aims to evaluate the efficacy of the FRAIL+AP program, which integrates Comprehensive Geriatric Assessment (CGA) with a 12-week multicomponent exercise intervention, including visual-spatial gait retraining using the Tapiz Fisior system. The study will assess whether this intervention improves frailty status, physical performance, and functional independence, while reducing falls among community-dwelling older adults compared to standard care.

Conditions

Frail Elderly

Keywords

exercise; frailty; elderly; physiotherapy; primary care

Outcome Measures

Primary Outcomes (2)

• Change in frailty status measured by the FRAIL Scale

  Change in FRAIL Scale score from baseline to the end of the 12-week intervention. The FRAIL Scale classifies participants as robust (0), pre-frail (1-2), or frail (3-5).

  Baseline and 12 weeks

• Change in physical performance measured by the Short Physical Performance Battery (SPPB)

  Change in SPPB score from baseline to the end of the 12-week intervention. The SPPB evaluates balance, gait speed, and lower-extremity strength, with higher scores indicating better physical performance.

  Baseline and 12 weeks

Secondary Outcomes (8)

• Incidence of Falls

  Baseline and 12 weeks

• Musculoskeletal Pain Intensity

  Baseline and 12 weeks

• Mood and Affective Status

  Baseline and 12 weeks

• Functional Independence

  Baseline and 12 weeks

• Nutritional Status

  Baseline and 12 weeks

Study Arms (2)

FRAIL+AP Program

EXPERIMENTAL

Participants receive a 12-week intervention consisting of a Comprehensive Geriatric Assessment (CGA), health education, and a multicomponent exercise program combining strength, balance, mobility, flexibility, and visual-spatial gait retraining using the Tapiz Fisior system. The intervention includes one supervised session and one home-based session per week.

Behavioral: FRAIL+AP Program

Usual Care

ACTIVE COMPARATOR

Participants receive standard primary care follow-up according to the Canary Health Service guidelines, including routine medical care and general lifestyle recommendations, without participation in the FRAIL+AP structured exercise program.

Other: Usual Care

Interventions

FRAIL+AP Program BEHAVIORAL

A 12-week multicomponent intervention including Comprehensive Geriatric Assessment, health education, strength training, balance exercises, mobility training, flexibility exercises, and visual-spatial gait retraining using the Tapiz Fisior system. Participants attend one supervised session and perform one home-based session per week.

FRAIL+AP Program

Usual Care OTHER

Standard primary care management according to regional healthcare guidelines without structured exercise intervention.

Usual Care

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling adults aged 70 years or older.
• Ability and willingness to provide written informed consent.
• Medical clearance to participate in low-to-moderate intensity physical exercise.
• Presence of frailty or pre-frailty defined by meeting at least two of the following criteria:
• Functional independence sufficient to participate in the intervention (Barthel Index \>80.
• FRAIL Scale score ≥ 1.
• Short Physical Performance Battery (SPPB) score \< 10.
• Gait speed \< 0.8 m/s.
• Timed Up and Go (TUG) test \> 12 seconds.
• Registered at one of the participating primary care centers.

You may not qualify if:

• Absolute contraindications to physical exercise, including recent acute myocardial infarction, unstable angina, severe uncontrolled cardiovascular disease, or severe uncorrected aortic stenosis.
• Severe cognitive impairment preventing comprehension of study procedures or exercise instructions.
• Severe psychiatric disorders interfering with participation.
• Absence of a legally authorized representative when required.
• Severe uncontrolled behavioral disturbances.
• Any acute or chronic medical condition considered by the investigators to make participation unsafe.
• Discontinuation Criteria:
• Failure to attend the initial mandatory health education workshop.
• Attendance at fewer than 6 of the 12 scheduled supervised exercise sessions.
• Development of an acute medical condition that results in a temporary or permanent contraindication to physical activity.
• Participant withdrawal of informed consent.

Sponsors & Collaborators

• Universidad Europea de Madrid: lead

Study Sites (1)

Centro de Salud Tacoronte

Tacoronte, Santa Cruz de Tenerife, 38350, Spain

RECRUITING

Related Publications (14)

• Studenski S, Perera S, Patel K, Rosano C, Faulkner K, Inzitari M, Brach J, Chandler J, Cawthon P, Connor EB, Nevitt M, Visser M, Kritchevsky S, Badinelli S, Harris T, Newman AB, Cauley J, Ferrucci L, Guralnik J. Gait speed and survival in older adults. JAMA. 2011 Jan 5;305(1):50-8. doi: 10.1001/jama.2010.1923.

  PMID: 21205966 BACKGROUND

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

• Vellas B, Guigoz Y, Garry PJ, Nourhashemi F, Bennahum D, Lauque S, Albarede JL. The Mini Nutritional Assessment (MNA) and its use in grading the nutritional state of elderly patients. Nutrition. 1999 Feb;15(2):116-22. doi: 10.1016/s0899-9007(98)00171-3.

  PMID: 9990575 BACKGROUND

• Yesavage JA, Brink TL, Rose TL, Lum O, Huang V, Adey M, Leirer VO. Development and validation of a geriatric depression screening scale: a preliminary report. J Psychiatr Res. 1982-1983;17(1):37-49. doi: 10.1016/0022-3956(82)90033-4.

  PMID: 7183759 BACKGROUND

• Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle aged African Americans. J Nutr Health Aging. 2012 Jul;16(7):601-8. doi: 10.1007/s12603-012-0084-2.

  PMID: 22836700 BACKGROUND

• Alegre-Tamariz J, Sanchez-Medina J, Runzer-Colmenares FM, Avila-Rodriguez C, Bermejo-Franco A, Parodi JF. Impact of a functional gait training program as a complementary strategy to improve physical function in older adults: a randomized clinical trial. BMC Geriatr. 2025 Oct 21;25(1):789. doi: 10.1186/s12877-025-06471-x.

  PMID: 41120990 BACKGROUND

• Izquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.

  PMID: 34409961 BACKGROUND

• Dent E, Martin FC, Bergman H, Woo J, Romero-Ortuno R, Walston JD. Management of frailty: opportunities, challenges, and future directions. Lancet. 2019 Oct 12;394(10206):1376-1386. doi: 10.1016/S0140-6736(19)31785-4.

  PMID: 31609229 BACKGROUND

• 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.

  PMID: 31609228 BACKGROUND

• Rodriguez-Manas L, Feart C, Mann G, Vina J, Chatterji S, Chodzko-Zajko W, Gonzalez-Colaco Harmand M, Bergman H, Carcaillon L, Nicholson C, Scuteri A, Sinclair A, Pelaez M, Van der Cammen T, Beland F, Bickenbach J, Delamarche P, Ferrucci L, Fried LP, Gutierrez-Robledo LM, Rockwood K, Rodriguez Artalejo F, Serviddio G, Vega E; FOD-CC group (Appendix 1). Searching for an operational definition of frailty: a Delphi method based consensus statement: the frailty operative definition-consensus conference project. J Gerontol A Biol Sci Med Sci. 2013 Jan;68(1):62-7. doi: 10.1093/gerona/gls119. Epub 2012 Apr 16.

  PMID: 22511289 BACKGROUND

• 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.

  PMID: 23764209 BACKGROUND

• Fried LP, Tangen CM, Walston J, Newman AB, Hirsch C, Gottdiener J, Seeman T, Tracy R, Kop WJ, Burke G, McBurnie MA; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci. 2001 Mar;56(3):M146-56. doi: 10.1093/gerona/56.3.m146.

  PMID: 11253156 BACKGROUND

• 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.

  PMID: 23395245 BACKGROUND

• Beard JR, Officer A, de Carvalho IA, Sadana R, Pot AM, Michel JP, Lloyd-Sherlock P, Epping-Jordan JE, Peeters GMEEG, Mahanani WR, Thiyagarajan JA, Chatterji S. The World report on ageing and health: a policy framework for healthy ageing. Lancet. 2016 May 21;387(10033):2145-2154. doi: 10.1016/S0140-6736(15)00516-4. Epub 2015 Oct 29.

  PMID: 26520231 BACKGROUND

Related Links

• Universidad Europea

MeSH Terms

Conditions

Motor Activity; Frailty

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ángel Moisés Reyes Abreu, Registered Nurse

  Centro médico Tacoronte. Adress: Carr. Gral. del Nte., 5, 38350 Tacoronte, Santa Cruz de Tenerife

  PRINCIPAL INVESTIGATOR

• Alberto Bermejo Franco, PhD (Physiotherapy)

  Universidad Europea de Madrid. Adress: C/ Tajo, S/N. 28670 Villaviciosa de Odón (Madrid)

  STUDY DIRECTOR

Central Study Contacts

Ángel Moisés Reyes Abreu, Registered Nurse

CONTACT

+34922474058; enf.enlacetacoronte@gmail.com

Alberto Bermejo Franco, PhD (Physiotherapy)

CONTACT

+34656932144; alberto.bermejo@universidadeuropea.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to treatment allocation. Due to the nature of the intervention, participants and care providers cannot be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ángel Moisés Reyes Abreu

Model Details: Participants will be randomly assigned in a 1:1 ratio to either the FRAIL+AP intervention group or a usual-care control group. Both groups will be followed in parallel throughout the 12-week study period.

Study Record Dates

• First Submitted: June 7, 2026
• First Posted: June 11, 2026
• Study Start: May 28, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

ES (1)