Clinical Deterioration
Conditions
Keywords
hospital acquired disability, exercise, function, cognition
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).
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.
Interventions
OTHERBehavioral: 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
Sponsors
Fundacion Miguel Servet
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional status | Through study completion, an average of 3 months | Short Performance Physical Battery (SPPB) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Barthel Index | Through study completion, an average of 3 months] | Basic activities of daily living |
| Mini-Mental State Examination (MMSE) | Through study completion, an average of 3 months | Cognition |
| Trail Making Test A | Through study completion, an average of 3 months | Complex attention |
| GDS Yesavage | Through study completion, an average of 3 months | Depression |
| EuroQol-5D-3L | Through study completion, an average of 3 months | Quality of life |
| Number of medications | Through study completion, an average of 3 months | Number of medications before and after de intervention |
| Falls | Through study completion, an average of 3 months | Number of falls during the study |
| Mortality | Through study completion, an average of 3 months | Mortality during the study |
| Hospital Readmissions | Through study completion, an average of 3 months | Number of Hospital Readmissions |
| Hand Grip | Through study completion, an average of 3 months | Maximum isometric strength |
| Length of stay | Through study completion, an average of 3 months | Average length of hospital stay |
| SATED scale | Through study completion, an average of 3 months | Changes in sleep quality |
| Changes in plasma/serum proteomic profiles. | 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 |
| Changes in DNA methylation profiles and epigenetic age | 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. |
Countries
Spain
Contacts
CONTACTNicolas Martinez-Velilla
CONTACTFabricio Zambom-Ferraresi
PRINCIPAL_INVESTIGATORNicolas Martinez-Velilla
Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra
Outcome results
None listed