Vivifrail Exercise Program in Nonagenarians: Effects on Function, Muscle, and Cognition | NCT07731529

NCT07731529

Overview

NCT ID: NCT07731529
Lead Sponsor: Federal University of Rio Grande do SulOTHER
Official Title: Effects of a Multicomponent Exercise Program Based on the Vivifrail Protocol on Functional Capacity, Muscle Morphology, and Cognition in Nonagenarians: A Randomized Clinical Trial
Brief Summary: This randomized clinical trial investigates the effects of a home-based multicomponent exercise program (Vivifrail) on physical function, muscle morphology, and cognition in community-dwelling adults aged 90 years and older. Participants are randomized into three groups: Vivifrail at least twice a week, Vivifrail at least three times a week, or a control group. Outcomes are assessed at baseline, 12 weeks, and 24 weeks. The primary outcome is physical function measured by the Short Physical Performance Battery (SPPB).
Conditions: Frailty
Aging
Cognitive Decline

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 28, 2026Actual
Start Date: Jul 2026Estimated
Primary Completion Date: Sep 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Aged 90 years or older

Living in the community (own or family home)

Able to walk independently or with a walking aid (cane or walker), without third-party assistance

Minimum cognitive capacity to understand and perform the exercises (MMSE, education-adjusted cutoffs)

Adequate home conditions to perform the program

Availability of a family member or caregiver to support the sessions

Signed informed consent (with legal guardian assistance when needed)

Exclusion Criteria:

- Total inability to walk or permanent bedridden condition

Severe cognitive impairment preventing safe understanding and execution of exercises

Severe orthopedic, neurological, or rheumatological conditions preventing exercise

Concurrent participation in another structured exercise program

Anticipated unavailability (relocation, planned hospitalization, or institutionalization) during the intervention

Refusal to sign informed consent or absence of a legal guardian when required

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 54Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts and Locations

Central Contacts: ALESSANDRA Silva QUADROSContact
quadros.ale@gmail.com+5551991020557

Similar Studies

Participant Group/Arms

Vivifrail - 2 sessions/week (G1)Experimental

Home-based Vivifrail multicomponent exercise program performed at least twice a week for 24 weeks, individualized by functional profile (SPPB and Vivifrail passport).

Behavioral: Vivifrail multicomponent exercise program

Vivifrail - 3 sessions/week (G2)Experimental

Home-based Vivifrail multicomponent exercise program performed at least three times a week for 24 weeks, individualized by functional profile.

Behavioral: Vivifrail multicomponent exercise program

Control (GC)No Intervention

Participants maintain usual activities without a structured exercise program during the 24-week period.