Multicomponent Exercise to Prevent Hospitalization-Associated Disability
ConditionClinical Deterioration
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75+
SponsorFundacion Miguel Servet
About this trial
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
This trial accepts healthy volunteersQualifiers
Age equal to or greater than 75 years, admitted to the acute care unit for medical conditions.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Behavioral: Exercise
Other interventionMulticomponent 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
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: No exercise during hospitalizationNo intervention 0 interventions
Group B: Exercise during hospitalizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional status
Short Performance Physical Battery (SPPB)
Time frame
Through study completion, an average of 3 monthsSecondary outcomes
1
Barthel Index
Basic activities of daily living
Time frame
Through study completion, an average of 3 months]2
Mini-Mental State Examination (MMSE)
Cognition
Time frame
Through study completion, an average of 3 months3
Trail Making Test A
Complex attention
Time frame
Through study completion, an average of 3 months4
GDS Yesavage
Depression
Time frame
Through study completion, an average of 3 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov