IMPACT OF A MULTICOMPONENT PHYSICAL EXERCISE PROGRAM ON THE FUNCTIONAL CAPACITY OF PATIENTS ADMITTED TO AN INTERMEDIATE CARE HOSPITAL. VIVIFRAIL FOR A BETTER VIG-FRAIL.

Condition(s) studied

Investigational drug(s) / intervention(s)

vivifrail: The VIVIFRAIL program consists of exercises combining: * strength, * endurance, * balance, * and gait training, adapted to the participant's functional level according to: * SPPB score, * gait speed. Based on these results, an individualized multicomponent exercise program (Programs A, B, C, or D) will be prescribed. The intervention will begin during hospitalization once the patient is clinically stable.

Study summary

INTRODUCTION Physical exercise in frail individuals has demonstrated benefits in variables such as reduced mortality risk and improved frailty and quality of life. Specifically, the most beneficial type appears to be multicomponent exercise, which includes strength, endurance, balance, and gait training. Within this field, the VIVIFRAIL project is an internationally recognized physical exercise promotion program.

OBJECTIVES To analyze the effects of an individualized multicomponent physical exercise program as an effective method for preventing/improving functional status and frailty in individuals admitted to an intermediate care hospital (ICH).

To assess whether improvements in functionality/frailty are maintained 3-4 months after discharge and to evaluate the impact of the program on quality of life variables and health indicators at 6 months.

METHODOLOGY Design: randomized clinical trial with two groups (control and intervention) and 6 months of follow-up.

Study population: adults older than 65 years admitted to an intermediate care hospital (ICH).

Inclusion criteria: baseline Barthel Index ≥60, ability to communicate, ambulate, and complete the exercise program.

Primary variables: functionality (Short Physical Performance Battery - SPPB) and frailty (Frail-VIG Index).

Secondary variables: grip strength, depressive symptoms, fear of falling, mortality, institutionalization, hospital admissions/emergency room and primary care visits, level of physical activity, medications (number, analgesics, opioid use, antidepressants, anxiolytics), and quality of life.

Sample size: assuming a 15% loss to follow-up, the final required sample size is 120 patients. Linear mixed-effects models will be used with a significance level of 0.05.

Eligibility

Primary outcome measure(s)

• functionality — 12 weeks
  functionality (Short Physical Performance Battery - SPPB)

Trial sites (1)

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