The aim of this research is to analyze whether nutritional intervention combined with a multicomponent physical training program based on strength, balance, and aerobic exercises can prevent disability caused during hospitalization in individuals aged 75 years or older admitted for medical conditions, thereby improving functional and cognitive capacity. To achieve this objective, we will conduct a randomized clinical trial in which patients are randomly assigned to either the control group, which does not perform the physical training, or the intervention group, which participates in the multicomponent physical training program.
The main objective of the present study is to evaluate the differences in the impact of an intervention based solely on physical exercise on the functionality of hospitalized older patients, in an Acute Geriatric Unit, who are malnourished or at risk of malnutrition. As secondary objectives: 1. To assess and compare changes in body composition following the intervention during hospitalization. 2. To evaluate and compare dietary intake, appetite progression, and food consumption throughout the intervention period. 3. To compare in-hospital infectious complications between the two groups. 4. To describe and compare changes in nutritional biochemical parameters between groups after the intervention and 30 days post-discharge. 5. To study changes in other physical function measures throughout the study period and compare them. 6. To describe the presence of molecular markers related to senescence and sarcopenia in patients and compare them between groups at discharge. 7. To study and compare changes in participants' cognitive status. 8. To evaluate and compare changes in perceived quality of life. 9. To assess and compare changes in maximal dynamic strength before and after the intervention. 10. To describe and compare hospital stays and 30-day readmission rates of study participants. 11. To describe participants' personal satisfaction with the intervention. 12. To describe the presence of potential side effects attributed to the intervention during the study period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
102
Progressive, supervised multicomponent physical exercise program, including aerobic resistance, strength, and balance training. Strength training for lower limbs (leg press and knee extension) and upper limbs (seated chest press) will be adapted to each individual's functional capacity.
* Hospital physiotherapy for preventing nosocomial disability when necessary. * Hospital diet modifications appropriate to each participant's clinical situation. * Oral nutritional supplementation aimed at meeting daily nutritional requirements: 30 kcal/kg body weight, 1.5-2 g protein/kg body weight, 25 g daily fiber. * Approximate free water intake: women 1.5 L/day, men 2 L/day (unless clinically restricted).
University Hospital of Navarra
Pamplona, Navarre, Spain
RECRUITINGFunction
SPPB - Short Physical Performance Battery
Time frame: Through study completion, an average of 4 days
Anthropometrical Measurements
Bioimpedance: PHASE ANGLE (PhA), Fat-Free Mass (FFM) and Muscle Mass (MM). Conventional and vectorial bioelectrical impedance analysis with a single-frequency bioelectrical impedance analyzer at 50 kHz (BIA 101 RJL, Akern Bioresearch, Florence, Italy)
Time frame: Through study completion, an average of 4 days
Dietary intake
Semi-quantitative questionnaire and a daily appetite assessment
Time frame: Through study completion, an average of 4 days
Number and type of infectious complications
Time frame: Through study completion, an average of 4 days
Nutritional status biomarkers
In blood: proteins, prealbumin, albumin, transferrin, lymphocytes, 25-hydroxyvitamin D, C-reactive protein.
Time frame: Through study completion, an average of 4 days, and 30 days post-discharge
Functional status
Barthel Index, Lawton Index
Time frame: Through study completion, an average of 4 days, and 30 days post-discharge
Frailty status
Linda Fried's Frailty Scale, from 0 to 5 (0 robust; 1,2 pre-frail; 3 to 5 frail).
Time frame: Baseline
Strength of upper and lower limbs
Leg press, chest press, knee extension, and handgrip strength
Time frame: Through study completion, an average of 4 days
Cognitive status
Mini-Mental State Examination, 4AT
Time frame: Through study completion, an average of 4 days
Affective status
Yesavage's 15-item Geriatric Depression Scale (GDS-15)
Time frame: Through study completion, an average of 4 days
Quality of life of participants
EuroQoL-5D-3L
Time frame: Through study completion, an average of 4 days
Adverse effects possibly attributed to the intervention
Time frame: Through study completion, an average of 4 days
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