Effects of VIVIFRAIL Program on Functional Capacity and Geriatric Syndromes in the Elderly.

NCT07436715 | Not Yet Recruiting

• 1 other identifier: VIVIAL
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this quasi-experimental, pretest-posttest study is to evaluate the effectiveness of the Vivifrail multicomponent physical exercise program in improving the functional capacity of pre-frail and frail older adults (aged 70 and older) attending the Virgen del Mar Health Center in Almería. The main questions it aims to answer are:

• Does functional capacity, as measured by the Short Physical Performance Battery (SPPB), significantly improve after participating in the Vivifrail program?
• What is the effect of the Vivifrail program on various geriatric syndromes and associated health conditions (e.g., fall risk, sarcopenia, chronic pain, mild cognitive impairment, depression), and what patient profile is most likely to benefit from the intervention?
• As a single-arm interventional study, there is no parallel comparison group. Researchers will compare each participant's outcomes against their own baseline at three time points (baseline, week 6, and week 12) to assess for significant improvements following the intervention. Participants will:
• Complete a 12-week home-based, multicomponent physical exercise program (five sessions per week including strength, balance, flexibility, and aerobic endurance training), tailored to their baseline functional level.
• Attend three in-person visits at the health center (baseline, a 6-week follow-up, and a final visit at 12 weeks) for the research staff to assess their clinical, functional, and sociodemographic variables.
• Complete an Activity Diary to record their home-based sessions and perceived rate of exertion in order to monitor adherence.
• Receive biweekly follow-up phone calls from the research team to reinforce motivation, track adherence, and monitor for any potential adverse events (e.g., falls, pain).

Conditions

Fragility

Keywords

Fragility; Exercise; Primary Care

Outcome Measures

Primary Outcomes (1)

• Change in Functional Capacity measured by the Short Physical Performance Battery (SPPB)

  The SPPB assesses physical performance and functional capacity through three sequential subtests: static balance (side-by-side, semi-tandem, and tandem stands for 10 seconds each), gait speed (time to walk 4 meters at a normal pace), and lower body strength (time to rise from a chair and sit down 5 consecutive times). The total SPPB score is calculated by summing the scores of the three subtests, yielding a final continuous score that ranges from 0 to 12. Clinical thresholds: A total score of \< 10 points indicates a high probability of frailty and an elevated risk of disability and falls. According to the Vivifrail classification, the scores categorize the patient's functional level as Disability (0-3 points), Frailty (4-6 points), Pre-frailty (7-9 points), or Robustness (10-12 points). A change of 1 point is considered clinically meaningful.

  Baseline, Week 6, and Week 12

Secondary Outcomes (12)

• Body Mass Index (BMI)

  Baseline, Week 6, and Week 12

• Chronic Pain Intensity measured by the Visual Analogue Scale (VAS)

  Baseline, Week 6, and Week 12

• Appetite Perception measured by the Visual Analogue Scale (VAS)

  Baseline, Week 6, and Week 12

• Proportion of Participants with High Fall Risk according to Vivifrail Criteria

  Baseline, Week 6, and Week 12

• Functional Mobility measured by the Timed Up and Go (TUG) Test

  Baseline, Week 6, and Week 12

Study Arms (1)

Vivifrail Exercise Program

EXPERIMENTAL

All participants in this single-arm study are assigned to the experimental group. Following a baseline clinical and functional assessment, participants are categorized into specific functional profiles based on their frailty status and fall risk. Participants are monitored over a 12-week period, which includes three in-person visits at the health center (baseline, week 6, and week 12) for functional reassessment, alongside biweekly telephone follow-ups by the research team to monitor adherence, safety, and potential adverse events.

Other: Behavioral: Vivifrail multicomponent physical exercise program

Interventions

Behavioral: Vivifrail multicomponent physical exercise program OTHER

The Vivifrail multicomponent physical exercise program is a structured, 12-week home-based regimen. The standardized protocol requires 5 sessions per week: 3 non-consecutive days of 45-60 minute multicomponent training (focusing on upper and lower body strength using household items like water bottles or elastic bands, static/dynamic balance, and flexibility) and 2 days of 20-40 minute aerobic endurance training (brisk walking). Exercise intensity is prescribed at a moderate rate of perceived exertion (Borg scale 4-6). A systematic progression in exercise load and duration is implemented starting at week 7, strictly adhering to the guidelines of the participant's assigned passport.

Vivifrail Exercise Program

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants aged 70 years or older.
• Classified as pre-frail or frail according to the FRAIL scale (score ≥ 1).
• Barthel Index score ≥ 60 points.
• Ability to communicate effectively.
• Ability to ambulate, with or without assistive devices.

You may not qualify if:

• Recent acute myocardial infarction or unstable angina.
• Uncontrolled atrial or ventricular arrhythmias.
• Dissecting aortic aneurysm.
• Severe aortic stenosis.
• Acute endocarditis or pericarditis.
• Uncontrolled arterial hypertension.
• Acute thromboembolic disease.
• Severe acute heart failure.
• Severe acute respiratory failure.
• Uncontrolled orthostatic hypotension.
• Diabetes mellitus with acute decompensation or uncontrolled hypoglycemia.
• Recent bone fracture within the last month.
• Institutionalization (e.g., nursing home residents).

Sponsors & Collaborators

• Elena Pérez Expósito, MD: lead

Study Sites (1)

Primary Care Center Virgen del Mar (Centro de Salud Virgen del Mar)

Almería, ALMERÍA, 04009, Spain

Location

Related Publications (2)

• Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.

  PMID: 35150086 BACKGROUND

• Guralnik JM, Simonsick EM, Ferrucci L, Glynn RJ, Berkman LF, Blazer DG, Scherr PA, Wallace RB. A short physical performance battery assessing lower extremity function: association with self-reported disability and prediction of mortality and nursing home admission. J Gerontol. 1994 Mar;49(2):M85-94. doi: 10.1093/geronj/49.2.m85.

  PMID: 8126356 BACKGROUND

Related Links

• Ministerio de Sanidad. Actualización del documento de consenso sobre prevención de la fragilidad en la persona mayor (2022).
• Integrated care for older people: guidelines on community-level interventions to manage declines in intrinsic capacity.
• Izquierdo M. Prescripción de ejercicio físico. El programa Vivifrail como modelo. Nutr Hosp 2019;36(N.o Extra. 2):50-56.

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Elena Pérez Expósito, MD

CONTACT

+34 950 17 50 50; elena.perez.exposito.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Family Medicine Resident

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: March 16, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)