RecruitingNot ApplicableNCT06634147

Prevention of Functional and Cognitive Impairment Through a Multicomponent Exercise Program in Hospitalized Older Adults

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)


Sponsor

Fundacion Miguel Servet

Enrollment

296 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine whether a multicomponent exercise program improves functional capacity and cognitive status in hospitalized elderly patients aged 75 and older. Additionally, the study aims to assess the impact of this program on medication use, quality of life, and overall health outcomes. Key questions include whether the program enhances functional and cognitive capacities and which subgroups benefit most, such as frail patients or those with cognitive impairment. Participants will engage in a structured exercise program that includes strength training, balance exercises, and walking, all designed to improve mobility and reduce fall risk. They will attend supervised sessions several times a week, allowing for individualized attention and adjustments based on their abilities and health status. Throughout the study, changes in functional capacity will be monitored using standardized assessments that measure mobility, strength, and overall physical functioning. Cognitive assessments will evaluate any changes in cognitive status during the intervention and follow-up periods post-discharge. Participants will provide information on medication usage to analyze whether the exercise program can reduce the need for medications or help manage common polypharmacy issues. Surveys and interviews will assess participants' quality of life, including physical, emotional, and social well-being, before and after the intervention. Follow-up assessments will track progress and outcomes, ensuring long-term benefits of the exercise program are documented. The study will include a diverse sample from multiple centers, focusing on individuals aged over 75 who are hospitalized in Geriatrics and Internal Medicine services across participating centers (HUN, CHU-T, ULSBM, and HNSM). Exclusion criteria will ensure safety, excluding those with terminal illnesses or significant contraindications for exercise. This clinical trial aims to recruit 296 patients, providing valuable insights into the benefits of physical activity for elderly patients during hospitalization and informing future care practices.


Eligibility

Min Age: 75 Years

Inclusion Criteria1

  • Age equal to or greater than 75 years, admitted to the acute care unit for medical conditions.

Exclusion Criteria8

  • 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.

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Interventions

BEHAVIORALExercise

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


Locations(2)

Hospital Universitario de Navarra - Navarrabiomed

Pamplona, Navarre, Spain

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

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NCT06634147


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