Multicomponent Exercise to Prevent Hospitalization-Associated Disability

NCT07707310 | Recruiting

• 1 other identifier: FIS_PreventionDisability
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Clinical Deterioration

Keywords

hospital acquired disability; exercise; function; cognition

Outcome Measures

Primary Outcomes (1)

• Functional status

  Short Performance Physical Battery (SPPB)

  Through study completion, an average of 3 months

Secondary Outcomes (14)

• Barthel Index

  Through study completion, an average of 3 months]

• Mini-Mental State Examination (MMSE)

  Through study completion, an average of 3 months

• Trail Making Test A

  Through study completion, an average of 3 months

• GDS Yesavage

  Through study completion, an average of 3 months

• EuroQol-5D-3L

  Through study completion, an average of 3 months

Study Arms (2)

No exercise during hospitalization

NO INTERVENTION

Exercise during hospitalization

EXPERIMENTAL

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

Interventions

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

Exercise during hospitalization

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Clinical Deterioration; Motor Activity

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Nicolas Martinez-Velilla

  Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Martinez-Velilla

CONTACT

+34 848422287; nicolas.martinez.velilla@navarra.es

Fabricio Zambom-Ferraresi

CONTACT

+34 848422287; fabricio.zambom.ferraresi@navarra.es

Study Design

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

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 16, 2026
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

ES (1)