Designing a Multicomponent Intervention for Improving Frailty. A Pilot Study in the Basque Country

NCT07637890 | Completed

• 1 other identifier: GUT-FRG-2024-11
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study tested whether a new program for older adults with frailty could realistically be carried out in primary health care. That is why the main objective of this study was to evaluate the viability and feasibility of the newly designed frailty intervention. People over 65 were recruited in two health centers and invited to join a 3 month program combining group exercise, a medication review by a pharmacist, and nutrition workshops. The study also collected information on mobility, strength, nutrition, mood, cognition, and quality of life. Most measures were taken at the start and again four and eight months later. The results will help refine the program and guide the design of a larger clinical trial.

Conditions

Frailty

Outcome Measures

Primary Outcomes (6)

• Recruitment rates

  The numbers of pre-selected participants who met the inclusion criteria and eventually agreed to participate, as well as the drop-outs and their reasons were registered.

  Baseline

• Time required to recruit the sample

  The time required to recruit the sample needed for the study was recorded.

  Baseline

• Participants evaluation time

  The professionals recorded the evaluation time each participant required

  From baseline to 8 months

• Professionals' opinion on the difficulty and adequacy of the process

  Professionals who performed the baseline and follow-up assessments completed a questionnaire on the difficulty and adequacy of the process

  From baseline to 8 months

• Adherence to the intervention

  Number of attended sessions was registered

  From baseline to 4 months

• Participant satisfaction

  Satisfaction was measured with an anonymous ad-hoc questionnaire, containing a total of 25 questions: The physical exercise and the nutritional components were evaluated with six questions each; general health improvements obtained during the intervention with 11; two last questions asked about the intention to keep exercising after the intervention ended and whether they would recommend this program to others.

  Month 4

Secondary Outcomes (12)

• Change from Baseline in Functional Capacity at 4 and 8 months

  From baseline to 8 months

• Change from Baseline in Physical Activity at 4 and 8 months

  From baseline to 8 months

• Change from Baseline in Handgrip Strength at 4 and 8 months

  From baseline to 8 months

• Change from Baseline in Eating Habits at 4 and 8 months

  From baseline to 8 months

• Change from Baseline in Nutritional Status at 4 and 8 months

  From Baseline to 8 months

Study Arms (1)

Intervention: physical exercise, polypharmacy review and nutritional care

EXPERIMENTAL

The arm is composed of people aged \>65, independent (≥95 points) and frail (Short Physical Performance Battery \<10 points). The entire arm group receives the multi-component intervention based on physical exercise, polypharmacy review and nutritional care.

Other: Multi-component intervention: physical exercise, polypharmacy review and nutritional care

Interventions

Multi-component intervention: physical exercise, polypharmacy review and nutritional care OTHER

Physical exercise: one-hour group sessions, twice a week for 12 consecutive weeks, at the Municipal Sports centre led by a licensed sports instructor. All sessions followed a standardized structure consisting of a warm-up phase of approximately 25 minutes, a strengthening phase of about 25 minutes adjusted to each participant's physical condition, and a final 10-minute relaxation phase including flexibility and balance exercises. Polypharmacy review: a primary care pharmacist reviewed the pharmacological treatments of each participant in order to detect potentially inappropriate prescriptions, following the STOPP/START criteria. Nutritional care: the dietary intervention consisted of three group workshops, one per month, lasting for an hour each. The three workshops, led by a nutritionist, covered the basics of healthy eating, dietary adaptations for specific conditions with recipe ideas, and strategies to prevent malnutrition and sarcopenia.

Intervention: physical exercise, polypharmacy review and nutritional care

Eligibility Criteria

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

You may qualify if:

• \>65 years old
• Barthel \>90 points (independent)
• Short Physical Performance Battery \<10 points (frail)

You may not qualify if:

• Having a terminal condition
• Suffering from pathologies with a poor prognosis
• Having difficulty in performing physical activities
• Not being able to communicate fluently in Spanish
• Presenting intellectual disabilities

Sponsors & Collaborators

• Biogipuzkoa Health Research Institute: lead

Study Sites (1)

Biogipuzkoa Health Research Institute. Primary Care Group. Epidemiology, Public Health and Primary Care Area.

San Sebastián, Gipuzkoa, 20014, Spain

Location

Related Publications (9)

• Tao A, Ho KHM, Yang C, Chan HYL. Effects of non-pharmacological interventions on psychological outcomes among older people with frailty: A systematic review and meta-analysis. Int J Nurs Stud. 2023 Apr;140:104437. doi: 10.1016/j.ijnurstu.2023.104437. Epub 2023 Jan 14.

  PMID: 36764033 BACKGROUND

• Sirikul W, Buawangpong N, Pinyopornpanish K, Siviroj P. Impact of multicomponent exercise and nutritional supplement interventions for improving physical frailty in community-dwelling older adults: a systematic review and meta-analysis. BMC Geriatr. 2024 Nov 18;24(1):958. doi: 10.1186/s12877-024-05551-8.

  PMID: 39558234 BACKGROUND

• Morin KH. Clarifying the Importance of Pilot Studies. J Nurs Educ. 2023 Sep;62(9):487-488. doi: 10.3928/01484834-20230712-03. Epub 2023 Sep 1. No abstract available.

  PMID: 37672495 BACKGROUND

• Gutierrez-Valencia M, Izquierdo M, Cesari M, Casas-Herrero A, Inzitari M, Martinez-Velilla N. The relationship between frailty and polypharmacy in older people: A systematic review. Br J Clin Pharmacol. 2018 Jul;84(7):1432-1444. doi: 10.1111/bcp.13590. Epub 2018 May 3.

  PMID: 29575094 BACKGROUND

• Rashidi Pour Fard N, Amirabdollahian F, Haghighatdoost F. Dietary patterns and frailty: a systematic review and meta-analysis. Nutr Rev. 2019 Jul 1;77(7):498-513. doi: 10.1093/nutrit/nuz007.

  PMID: 31038679 BACKGROUND

• Yang X, Li S, Xu L, Liu H, Li Y, Song X, Bao J, Liao S, Xi Y, Guo G. Effects of multicomponent exercise on frailty status and physical function in frail older adults: A meta-analysis and systematic review. Exp Gerontol. 2024 Nov;197:112604. doi: 10.1016/j.exger.2024.112604. Epub 2024 Oct 21.

  PMID: 39426607 BACKGROUND

• Nan J, Duan Y, Wu S, Liao L, Li X, Zhao Y, Zhang H, Zeng X, Feng H. Perspectives of older adults, caregivers, healthcare providers on frailty screening in primary care: a systematic review and qualitative meta-synthesis. BMC Geriatr. 2022 Jun 3;22(1):482. doi: 10.1186/s12877-022-03173-6.

  PMID: 35659258 BACKGROUND

• Rivas-Ruiz F, Machon M, Contreras-Fernandez E, Vrotsou K, Padilla-Ruiz M, Diez Ruiz AI, de Mesa Berenguer Y, Vergara I; Group GIFEA. Prevalence of frailty among community-dwelling elderly persons in Spain and factors associated with it. Eur J Gen Pract. 2019 Oct;25(4):190-196. doi: 10.1080/13814788.2019.1635113. Epub 2019 Oct 22.

  PMID: 31637940 BACKGROUND

• O'Caoimh R, Sezgin D, O'Donovan MR, Molloy DW, Clegg A, Rockwood K, Liew A. Prevalence of frailty in 62 countries across the world: a systematic review and meta-analysis of population-level studies. Age Ageing. 2021 Jan 8;50(1):96-104. doi: 10.1093/ageing/afaa219.

  PMID: 33068107 BACKGROUND

MeSH Terms

Conditions

Frailty

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2026
• First Posted: June 10, 2026
• Study Start: December 23, 2024
• Primary Completion: September 25, 2025
• Study Completion: September 25, 2025
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)