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

NCT06634147 | Recruiting

• 1 other identifier: PREDISC
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Clinical Deterioration

Keywords

hospital acquired disability; exercise; function; cognition

Outcome Measures

Primary Outcomes (1)

• Functional status

  Short Performance Physical Battery (SPPB)

  Through study completion, an average of 3 months

Secondary Outcomes (13)

• Barthel Index

  Through study completion, an average of 3 months

• Mini-Mental State Examination (MMSE)

  Through study completion, an average of 3 months

• Gait Speed.

  Through study completion, an average of 3 months

• Trail Making Test A

  Through study completion, an average of 3 months

• GDS Yesavage

  Through study completion, an average of 3 months

Study Arms (2)

Control

NO INTERVENTION

No exercise during hospitalization

Intervention group

EXPERIMENTAL

Exercise during hospitalization

Behavioral: Exercise

Interventions

Exercise BEHAVIORAL

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

Intervention group

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Miguel Servet: lead

Study Sites (2)

Hospital Universitario de Navarra - Navarrabiomed

Pamplona, Navarre, 31008, Spain

RECRUITING

Hospital Universitario de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

Related Publications (3)

• Martinez-Velilla N, Abizanda P, Gomez-Pavon J, Zambom-Ferraresi F, Saez de Asteasu ML, Fiatarone Singh M, Izquierdo M. Effect of an Exercise Intervention on Functional Decline in Very Old Patients During Acute Hospitalizations: Results of a Multicenter, Randomized Clinical Trial. JAMA Intern Med. 2022 Mar 1;182(3):345-347. doi: 10.1001/jamainternmed.2021.7654.

  PMID: 35040873 BACKGROUND

• Martinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Saez de Asteasu ML, Lucia A, Galbete A, Garcia-Baztan A, Alonso-Renedo J, Gonzalez-Glaria B, Gonzalo-Lazaro M, Apezteguia Iraizoz I, Gutierrez-Valencia M, Rodriguez-Manas L, Izquierdo M. Effect of Exercise Intervention on Functional Decline in Very Elderly Patients During Acute Hospitalization: A Randomized Clinical Trial. JAMA Intern Med. 2019 Jan 1;179(1):28-36. doi: 10.1001/jamainternmed.2018.4869.

  PMID: 30419096 BACKGROUND

• Martinez-Velilla N, Santos Silva R, Rodriguez PA, Xandri JM, Pais A, Rodriguez EU, Abellan van Kan G, Peyrusque E, Izco-Cubero M, Gonzalez de la Riva MF, Belo R, Zambom-Ferraresi F, Beistegui IE, Chenhuichen C, Galbete A, Gomes AI, Heras E, Zambom-Ferraresi F. Prevention of functional and cognitive impairment through a multicomponent exercise program during and after hospitalization of older adults (PREDISC): Study protocol for a multicenter randomized clinical trial. PLoS One. 2025 Sep 25;20(9):e0332391. doi: 10.1371/journal.pone.0332391. eCollection 2025.

  PMID: 40997056 DERIVED

MeSH Terms

Conditions

Clinical Deterioration; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• NICOLAS Martinez-Velilla, PhD

  Navarrabiomed-Fundación Miguel Servet-Hospital de Navarra

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas Martinez-Velilla, PhD

CONTACT

+34 848422287; nicolas.martinez.velilla@navarra.es

Fabricio Z Zambom-Ferraresi, PhD

CONTACT

+34 848422287; fabricio.zambom.ferraresi@navarra.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter Randomized Clinical Trial

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: October 9, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years after the completion of the study
• Access Criteria: Data Sharing Agreement: Establish a formal data sharing agreement outlining the terms of use, responsibilities, and conditions for accessing the IPD. This can help protect participant confidentiality and ensure compliance with ethical standards. Secure Data Repository: Utilize a secure data repository or platform (e.g., Open Science Framework, Dryad) where researchers can access the IPD. This platform should have robust security measures to protect sensitive data. Anonymization Procedures: Implement procedures to anonymize the data before sharing. This may include removing identifiable information and aggregating data to prevent re-identification of participants. Access Criteria: Define clear criteria for who can access the IPD. This could include stipulations that only qualified researchers with relevant expertise can apply for access.

Locations

ES (2)