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.

NCT07637383 | Recruiting

• 1 other identifier: 11/7/2006A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Functionality; Fragility

Keywords

Frailty; physical exercise; Quality of life

Outcome Measures

Primary Outcomes (1)

• functionality

  functionality (Short Physical Performance Battery - SPPB)

  12 weeks

Study Arms (2)

Control group

NO INTERVENTION

Participants assigned to the control group will follow the usual therapeutic plan and recommendations without individualized physical exercise prescription.

intervention group

OTHER

Participants assigned to the intervention group will receive instruction from the principal investigator and trained physiotherapy staff regarding the VIVIFRAIL multicomponent physical exercise program.

Other: vivifrail

Interventions

vivifrail OTHER

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.

intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

* baseline Barthel Index ≥60 * ability to communicate, ambulate, and complete the exercise program

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina: lead
• Institut Catala de Salut: collaborator
• Consorci Hospitalari de Vic: collaborator
• Althaia Xarxa Assistencial Universitària de Manresa: collaborator

Study Sites (1)

Hospital Sant Andreu. Sant Andreu Salut

Manresa, Barcelona, 08240, Spain

RECRUITING

MeSH Terms

Conditions

Frailty; Motor Activity

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Central Study Contacts

Raquel Gómez Cortijo

CONTACT

938743312; rgomezcortijo@gmail.com

Anna Ruiz

CONTACT

938743312; anna.ruiz@umedicina.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 28, 2026
• First Posted: June 9, 2026
• Study Start: February 18, 2026
• Primary Completion: August 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 9, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)