Multicomponent Exercise to Prevent Hospitalization-Associated Disability (FIS_Prevention)

Prevention of Disability in Older Adults: From the Patient to the Molecule - A Randomized Controlled Trial (RCT)

The study is a randomized controlled trial conducted in the Geriatrics Department of a tertiary hospital in Spain (Hospital Universitario de Navarra). Participants aged 75 years or older will be recruited within the first 48 hours of admission to the acute care ward. Eligible hospitalized patients will be randomly assigned to either the intervention or control group using permuted block randomization (block sizes of 8 and 10), with consideration of gender balance.

Data will be collected at four time points: baseline assessment, hospital discharge, 1 month, and 3 months post-discharge.

Inclusion criteria include age ≥75 years and admission to the acute care unit. Exclusion criteria include refusal or inability to provide informed consent, life expectancy <3 months or terminal illness (oncological or non-oncological), inability to complete follow-up, medical contraindications to exercise, severe neurocognitive impairment (GDS-FAST stage 7), or severe disability (Barthel Index <35).

Study Overview

• Status: Recruiting
• Conditions: Clinical Deterioration
• Intervention / Treatment: Other: Behavioral: Exercise

Detailed Description

General Objective

To determine whether an intervention consisting of a multicomponent physical exercise program based on strength, balance, and aerobic training can prevent hospitalization-associated disability in adults aged 75 years and older admitted for acute medical conditions, while improving functional and cognitive capacity.

Specific Objectives

1. To analyze and identify the patient subgroups that derive the greatest benefit from the intervention in order to optimize healthcare resource allocation (e.g., frail patients, patients with cognitive impairment, malnourished patients), and to characterize these subgroups.
2. To identify the sociodemographic, clinical, functional, and cognitive characteristics associated with greater responsiveness to the intervention, as well as the type of intervention that provides the greatest benefit.
3. To integrate clinical and molecular approaches through the assessment of epigenetic and inflammatory biomarkers, enabling the evaluation of parameters that have not previously been incorporated into studies of this kind.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nicolas Martinez-Velilla; Phone Number: +34 848422287; Email: nicolas.martinez.velilla@navarra.es
• Study Contact Backup: Name: Fabricio Zambom-Ferraresi; Phone Number: +34 848422287; Email: fabricio.zambom.ferraresi@navarra.es

Study Locations

• Spain
  • Pamplona, Spain, 31008
    • Recruiting
    • Hospital Universitario de Navarra
    • Contact: Nicolas Martinez-Velilla; Phone Number: +34 848422287; Email: nicolas.martinez.velilla@navarra.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Age equal to or greater than 75 years, admitted to the acute care unit for medical conditions.

Exclusion Criteria:

• Explicit refusal expressed verbally or refusal to sign the informed consent by the patient/main caregiver/legal guardian or inability to obtain it.
• Life expectancy of less than 3 months or terminal oncological or non -oncological disease.
• Inability to follow up.
• Inability to participate in a multicomponent exercise program.
• Medical contraindication to exercise.
• Major neurocognitive disorder at moderate to severe stage (GDS - Fast Reisberg 5-7).
• Moderate to severe disability (measured by the Barthel Index (BI <60)). Expected hospital stay of less than 6 days.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No exercise during hospitalization
Experimental: Exercise during hospitalization; Multicomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed. The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization. This will be supervised by the research team from the Geriatrics Unit. Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN. The multicomponent physical training program will consist of chair squat exercises. The main part of the training will utilize machines for strength training for the lower extremit	Other: Behavioral: Exercise; Multicomponent individualized exercise intervention As mentioned earlier, patients in the control group (G0) will receive the usual care currently provided to other patients, which includes a referral to physical therapy if needed. The intervention for the multicomponent physical exercise intervention group (G1) will consist of a multicomponent physical training program that includes progressive and supervised aerobic endurance, strength, and balance training lasting 4-7 days during their hospitalization. This will be supervised by the research team from the Geriatrics Unit. Additionally, after hospital discharge, they will receive individualized guidelines to engage in multicomponent physical exercise for 3 months, along with individualized recommendations from the Nutrition and Dietetics Service of HUN. The multicomponent physical training program will consist of chair squat exercises. The main part of the training will utilize machines for strength training for the lower extremit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional status	Short Performance Physical Battery (SPPB)	Through study completion, an average of 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mini-Mental State Examination (MMSE)	Cognition	Through study completion, an average of 3 months
Trail Making Test A	Complex attention	Through study completion, an average of 3 months
GDS Yesavage	Depression	Through study completion, an average of 3 months
EuroQol-5D-3L	Quality of life	Through study completion, an average of 3 months
Number of medications	Number of medications before and after de intervention	Through study completion, an average of 3 months
Falls	Number of falls during the study	Through study completion, an average of 3 months
Mortality	Mortality during the study	Through study completion, an average of 3 months
Hand Grip	Maximum isometric strength	Through study completion, an average of 3 months
SATED scale	Changes in sleep quality	Through study completion, an average of 3 months
Barthel Index	Basic activities of daily living	Through study completion, an average of 3 months]
Hospital Readmissions	Number of Hospital Readmissions	Through study completion, an average of 3 months
Length of stay	Average length of hospital stay	Through study completion, an average of 3 months
Changes in plasma/serum proteomic profiles.	Protein expression profiles will be assessed to identify changes in circulating proteins associated with the intervention and to explore potential biological pathways involved in the observed effects	Through study completion, an average of 3 months
Changes in DNA methylation profiles and epigenetic age	Buffy coat samples will be used for DNA extraction. Extracted DNA will be hybridized on DNA methylation arrays to assess genome-wide methylation profiles and identify differentially methylated regions/sites associated with the intervention. DNA methylation data will also be used to estimate biological age through established epigenetic clocks, allowing the evaluation of changes in epigenetic age and/or epigenetic age acceleration.	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: Fundacion Miguel Servet
• Investigators: Principal Investigator: Nicolas Martinez-Velilla, Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: exercise; cognition; function; hospital acquired disability
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Disease Progression; Pathological Conditions, Signs and Symptoms; Behavior; Clinical Deterioration; Motor Activity
• Other Study ID Numbers: FIS_PreventionDisability

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No