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NCT Number: NCT07707310

Multicomponent Exercise to Prevent Hospitalization-Associated Disability

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).

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario de Navarra

Pamplona, 31008, Spain

Location status: Recruiting

Location contact

Nicolas Martinez-Velilla

CONTACT

[email protected]

+34 848422287

About this study

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

  • 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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral: Exercise

Other

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

Primary outcomes

  1. Functional status

    Time frame: Through study completion, an average of 3 months

    Short Performance Physical Battery (SPPB)

Secondary outcomes

  1. Barthel Index

    Time frame: Through study completion, an average of 3 months]

    Basic activities of daily living

  2. Mini-Mental State Examination (MMSE)

    Time frame: Through study completion, an average of 3 months

    Cognition

  3. Trail Making Test A

    Time frame: Through study completion, an average of 3 months

    Complex attention

  4. GDS Yesavage

    Time frame: Through study completion, an average of 3 months

    Depression

  5. EuroQol-5D-3L

    Time frame: Through study completion, an average of 3 months

    Quality of life

  6. Number of medications

    Time frame: Through study completion, an average of 3 months

    Number of medications before and after de intervention

  7. Falls

    Time frame: Through study completion, an average of 3 months

    Number of falls during the study

  8. Mortality

    Time frame: Through study completion, an average of 3 months

    Mortality during the study

  9. Hospital Readmissions

    Time frame: Through study completion, an average of 3 months

    Number of Hospital Readmissions

  10. Hand Grip

    Time frame: Through study completion, an average of 3 months

    Maximum isometric strength

  11. Length of stay

    Time frame: Through study completion, an average of 3 months

    Average length of hospital stay

  12. SATED scale

    Time frame: Through study completion, an average of 3 months

    Changes in sleep quality

  13. Changes in plasma/serum proteomic profiles.

    Time frame: Through study completion, an average of 3 months

    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

  14. Changes in DNA methylation profiles and epigenetic age

    Time frame: Through study completion, an average of 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fabricio Zambom-Ferraresi

CONTACT

[email protected]

+34 848422287

Nicolas Martinez-Velilla

CONTACT

[email protected]

+34 848422287

Sponsors and collaborators

Lead sponsor

Fundacion Miguel Servet

Other

Registry information

Official study title

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

Acronym: FIS_Prevention

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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