A supervised exercise program to prevent loss of function and thinking in hospitalized people 75 and older.
Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Older Adults (Geriatrics and Internal Medicine): a Randomized Clinical Trial. Multicenter Study (HUN, CHU-T, ULSBM, and HNSM)
NA · Fundacion Miguel Servet · NCT06634147
This trial tests whether a supervised multicomponent exercise program can help hospitalized people aged 75 and older keep or improve their mobility and thinking while in the hospital.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 296 (estimated) |
| Ages | 75 Years and up |
| Sex | All |
| Sponsor | Fundacion Miguel Servet (other) |
| Locations | 2 sites (Pamplona, Navarre and 1 other locations) |
| Trial ID | NCT06634147 on ClinicalTrials.gov |
What this trial studies
Hospitalized patients aged 75 and older are offered a multicomponent exercise program including strength training, balance exercises, and walking, delivered in supervised sessions several times per week with individualized adjustments. The program is compared to standard care to see if it produces better functional capacity and cognitive status by using standardized mobility, strength, and cognitive assessments. Researchers will also track medication use, quality of life, sleep, and longer-term outcomes like muscle mass, balance, and walking speed. Exploratory analyses include subgroup effects (for example frail patients or those with cognitive impairment) and possible omics-level changes.
Who should consider this trial
Good fit: Ideal candidates are hospitalized adults aged 75 or older who can safely participate in exercise, expect to stay at least six days, and do not have severe dementia or major disability.
Not a fit: Patients with a life expectancy under three months, moderate-to-severe major neurocognitive disorder (GDS 5-7), Barthel Index <60, a medical contraindication to exercise, or an expected hospital stay under six days are unlikely to benefit.
Why it matters
Potential benefit: If successful, the program could reduce hospital-associated loss of mobility and cognitive decline, improve quality of life, and lower medication-related complications for older inpatients.
How similar studies have performed: Previous research has shown that multicomponent exercise during hospitalization can reduce hospital-acquired disability and improve mobility (and sometimes cognition), so this approach has supporting evidence though questions remain about which subgroups benefit most.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Pamplona, Navarre and 1 other locations
- Hospital Universitario de Navarra - Navarrabiomed — Pamplona, Navarre, Spain (RECRUITING)
- Hospital Universitario de Navarra — Pamplona, Navarre, Spain (RECRUITING)
Study contacts
- Principal investigator: NICOLAS Martinez-Velilla, PhD — Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra
- Study coordinator: Nicolas Martinez-Velilla, PhD
- Email: nicolas.martinez.velilla@navarra.es
- Phone: +34 848422287
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Clinical Deterioration, hospital acquired disability, exercise, function, cognition