RCT to Analyze the Efficacy of a Spanish Healthcare ministRy Based In InTervention to Reduce Frailty Status in Prefrail Older Adults

NCT05002439 | Recruiting

• 1 other identifier: FRAILMERIT
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: The main objective is to analyze the efficacy of an intervention based on the algorithm proposed by the Spanish Healtcare Ministry (see figure in annex 1) at Primary Care level to reduce Frailty status or Physical Function in community-dwelling older adults. Secondary objectives are: 1. To analyze if the intervention is cost-effective; 2. To analyze if the intervention reduces hospitalizations and emergency department visits, incident disability, falls, institutionalization, mortality, Primary Care visits and Drug use, and improves quality of life. Methodology: Multicentric Randomized Clinical Trial in 273 Prefrail or Frail or with a gait speed lower that 0.8 m/s community-dwelling women and men with an age equal or greater to 70 years, attended in selected Primary Care centers of Spain (Albacete, Hellín, Barcelona, Madrid, La Carlota, and Tacoronte). Randomization will be made by clusters, being every cluster a different Primary Care center in order to avoid contamination. Randomization on a 1:1 relationship between groups. The main outcome variable will be Frailty status or Physical function change (main composite outcome) at 8-month follow-up measured with the Frailty Phenotype and the Short Physical Performance Battery (SPPB) respectively. All instrumentation will follow the guidelines of the Spanish Healthcare Ministry algorithm for frailty updated 2022. Intervention will consist on a groupal multicomponent physical exercise program, a nutritional intervention program and a training in Frailty to Primary Care centers. The intervention will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations of the Spanish Healthcare Ministry document, updated in 2022.

Conditions

Frailty; Aged; Exercise

Keywords

Frailty; Aged; Multimodal training

Outcome Measures

Primary Outcomes (1)

• Frailty status or Physical Function change (composite outcome)

  Frailty will be determined with the Frailty Phenotype and Physical Function with the SPPB

  8 months

Secondary Outcomes (3)

• Hospitalization

  1 year

• Emergency department visits

  1 year

• Mortality

  1 year

Study Arms (2)

Group multicomponent physical exercise program, nutritional intervention and Frailty training

EXPERIMENTAL

Group multicomponent physical exercise program, nutritional intervention program and Primary Care training in Frailty. The exercise program will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations presented in the Spanish Healthcare Ministry document updated 2022. This program includes balance, flexibility, and strength and power exercises. The program will be realized twice a week, during 45 minutes time, for 12 weeks, twice, with a discontinuation period of 2 months. Nutritional recommendations will de presented by a nutritionist at the beginning of the intervention to the Primary Care physicians. Primary Care Physicians will have the opportunity of referring high risk participants to their Geriatrics Department Participants when appropriate, following Healthcare Ministry algorithm

Other: Multicomponent physical exercise program and a nutritional intervention

Control group

NO INTERVENTION

Control group will receive usual care by their Primary Care Physicians. Healthy lifestyle recommendations including exercise and nutritional recommendations will be offered

Interventions

Multicomponent physical exercise program and a nutritional intervention OTHER

The exercise program will be delivered by trained experts in groups of 6 participants, and will be based on the recommendations presented in the Spanish Healthcare Ministry document. This program includes balance, flexibility, and strength and power exercises. The program will be realized twice a week, during 45 minutes time, for 16 weeks, twice a year. Nutritional intervention will be based on the results of MNA-SF. If the results of this instrument show normal nutrition status, general nutritional recommendations will de presented by a nutritionist twice a year before the physical exercise program. If MNA-SF shows nutritional risk or malnutrition, oral nutritional supplementation will be offered. Primary Care Physicians will have the opportunity of referring high risk participants to their Geriatrics Department Participants when appropriate, following Healthcare Ministry algorithm

Group multicomponent physical exercise program, nutritional intervention and Frailty training

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Community-dwelling adults with age equal or greater than 70 years.
• Barthel index \> 85
• Gait speed \< 0.8 m/s OR frailty /prefrailty using the frailty phenotype
• Ability to realize the physical exercise program
• Capacity to understand the procedures and interventions of the trial
• Capacity to understand and sign the informed consent

You may not qualify if:

• Major contraindications for exercise: Severe aortic valve stenosis, myocardial infarction in the previous 6 weeks, Venous thromboembolic disease in the previous 6 weeks.
• Inability to conduct the physical tests of the trial
• Inability to understand the procedures of the trial
• Active solid organ or hematologic neoplasm other than basocellular skin neoplasm, or life expectancy lower than one year.
• Surgical intervention programmed that could interfere with the physical exercise program.

Sponsors & Collaborators

• Complejo Hospitalario Universitario de Albacete: lead

Study Sites (1)

Complejo Hospitalario Universitario de Albacete

Albacete, 02006, Spain

RECRUITING

Related Publications (8)

• Kojima G, Iliffe S, Walters K. Frailty index as a predictor of mortality: a systematic review and meta-analysis. Age Ageing. 2018 Mar 1;47(2):193-200. doi: 10.1093/ageing/afx162.

  PMID: 29040347 BACKGROUND

• Hoogendijk EO, Romero L, Sanchez-Jurado PM, Flores Ruano T, Vina J, Rodriguez-Manas L, Abizanda P. A New Functional Classification Based on Frailty and Disability Stratifies the Risk for Mortality Among Older Adults: The FRADEA Study. J Am Med Dir Assoc. 2019 Sep;20(9):1105-1110. doi: 10.1016/j.jamda.2019.01.129. Epub 2019 Mar 8.

  PMID: 30853426 BACKGROUND

• Abizanda P, Romero L, Sanchez-Jurado PM, Martinez-Reig M, Gomez-Arnedo L, Alfonso SA. Frailty and mortality, disability and mobility loss in a Spanish cohort of older adults: the FRADEA study. Maturitas. 2013 Jan;74(1):54-60. doi: 10.1016/j.maturitas.2012.09.018. Epub 2012 Oct 26.

  PMID: 23107816 BACKGROUND

• Kojima G. Frailty as a Predictor of Nursing Home Placement Among Community-Dwelling Older Adults: A Systematic Review and Meta-analysis. J Geriatr Phys Ther. 2018 Jan/Mar;41(1):42-48. doi: 10.1519/JPT.0000000000000097.

  PMID: 27341327 BACKGROUND

• Kojima G. Frailty as a predictor of hospitalisation among community-dwelling older people: a systematic review and meta-analysis. J Epidemiol Community Health. 2016 Jul;70(7):722-9. doi: 10.1136/jech-2015-206978. Epub 2016 Mar 1.

  PMID: 26933121 BACKGROUND

• Apostolo J, Cooke R, Bobrowicz-Campos E, Santana S, Marcucci M, Cano A, Vollenbroek-Hutten M, Germini F, D'Avanzo B, Gwyther H, Holland C. Effectiveness of interventions to prevent pre-frailty and frailty progression in older adults: a systematic review. JBI Database System Rev Implement Rep. 2018 Jan;16(1):140-232. doi: 10.11124/JBISRIR-2017-003382.

  PMID: 29324562 BACKGROUND

• Tarazona-Santabalbina FJ, Gomez-Cabrera MC, Perez-Ros P, Martinez-Arnau FM, Cabo H, Tsaparas K, Salvador-Pascual A, Rodriguez-Manas L, Vina J. A Multicomponent Exercise Intervention that Reverses Frailty and Improves Cognition, Emotion, and Social Networking in the Community-Dwelling Frail Elderly: A Randomized Clinical Trial. J Am Med Dir Assoc. 2016 May 1;17(5):426-33. doi: 10.1016/j.jamda.2016.01.019. Epub 2016 Mar 3.

  PMID: 26947059 BACKGROUND

• 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. 2025 Dec 28. doi: 10.1111/jgs.70266. Online ahead of print.

  PMID: 41456342 DERIVED

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Pedro Abizanda Soler, MD,PhD

CONTACT

+34636557437; pabizanda@sescam.jccm.es

Almudena Avendaño Céspedes, RN, PhD

CONTACT

+34967597684; aavendanoc@sescam.jccm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomization will be made by clusters, being every cluster a different Primary Care center in order to avoid contamination. Randomization on a 1:1 relationship between groups.

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: August 12, 2021
• Study Start: January 1, 2020
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At data Journal publication

Locations

ES (1)