NCT07707310 Multicomponent Exercise to Prevent Hospitalization-Associated Disability
| NCT ID | NCT07707310 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion Miguel Servet |
| Condition | Clinical Deterioration |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2027-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 300 participants in total. It began in 2025-02-01 with a primary completion date of 2027-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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.
Contact & Investigator
Nicolas Martinez-Velilla
PRINCIPAL INVESTIGATOR
Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra
Frequently Asked Questions
Who can join the NCT07707310 clinical trial?
This trial is open to participants of all sexes, aged 75 Years or older, studying Clinical Deterioration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07707310 currently recruiting?
Yes, NCT07707310 is actively recruiting participants. Contact the research team at nicolas.martinez.velilla@navarra.es for enrollment information.
Where is the NCT07707310 trial being conducted?
This trial is being conducted at Pamplona, Spain.
Who is sponsoring the NCT07707310 clinical trial?
NCT07707310 is sponsored by Fundacion Miguel Servet. The principal investigator is Nicolas Martinez-Velilla at Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra. The trial plans to enroll 300 participants.