Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults

Summary

This study employs a randomized, controlled, paired, single-blind clinical trial design. The targeted demographic comprises individuals aged 60 and above. Following the initial assessment, participants will be randomly allocated to two groups: the Intervention Group (ViviFrail) and the Group Suggestions for a Healthy Life (CG), maintaining a 1:1 allocation ratio. Both the ViviFrail group and CG group will exhibit homogeneity in terms of their clinical characteristics and functional performance. The allocation of participants into respective groups will remain concealed from all assessors, ensuring a single-blind approach.

In the intervention group (ViviFrail), 25 participants will be instructed to engage in tailored physical exercises outlined in the VIVIFRAIL® protocol within the confines of their homes, with adaptations made according to their clinical conditions and functional performance.

Conversely, the Group Suggestions for a Healthy Life (CG) comprising 25 participants will receive exercise suggestions and guidance to maintain a healthy routine for a duration of three months. Subsequently, participants in the CG will undergo the VIVIFRAIL® program intervention for an additional three months.

Conditions

• Frailty
• Aging
• Physical Disability

Interventions

OTHER

Intervention group (ViviFrail)

The participant will be guided to follow a daily exercise routine at home, lasting 30-45 minutes, from Monday to Friday, over six months. A one-week break every six weeks for reassessment, totaling seven months of activities, will be provided. They will be informed that every six weeks, they may receive new exercises in their exercise passport or continue with the same, based on their physical reassessment. Each exercise passport will have a wheel illustrating the exercise circuit for easy reference. An 'Activity Diary' will be provided for tracking progress and frequency. During 'CIRCUIT' sessions, participants should complete the entire circuit, while 'WALKING' sessions should focus solely on walking for that day. They will be motivated to keep this diary updated. The ViviFrail exercise passports cater to various levels of physical frailty and fall risk and can be accessed at https://vivifrail.com/en/materials-2/.

OTHER

Group Suggestions for a Healthy Life (CG)

The participants in the group Suggestions for a healthy life (CG) will receive guidance on maintaining a healthy and independent lifestyle for three months. They will also be provided with a booklet containing strength, balance, and flexibility activities, suggesting that participants perform these activities five times a week, for around 30 minutes per day. At the end of the initial three complete months of the intervention (14 weeks), participants in the control group will commence the ViviFrail exercise protocol and will continue until the end of the study. Throughout the entire study period, participants in the control group will receive the same monitoring as the intervention group.

Sponsors & Collaborators

• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

  collaborator OTHER_GOV

• Pontificia Universidade Católica do Rio Grande do Sul

  lead OTHER

Principal Investigators

• Angelo Bós, Phd · Pontificia Universidade Católica do Rio Grande do Sul

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-05-28

Primary Completion

2025-01-31

Completion

2025-05-30

Countries

• Brazil

Study Locations