NCT06271239

Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults

Effect of Multicomponent Exercises on the Intrinsic Functional Capacity of Older Adults

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Pontificia Universidade Católica do Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Detailed description

Objective: This study aims to assess the impact of a multicomponent physical exercise intervention on the intrinsic functional capacity of older adults. Methodology: A randomized, controlled, paired, single-blind clinical trial will be conducted. Participants, aged 60 years or older, will be randomly assigned to either the Intervention Group (ViviFrail) or the Group Suggestions for a Healthy Life (CG). The study sample will consist of older individuals, both men and women, enrolled in the senior groups of the social assistance program administered by the City Hall of Porto Alegre. The initial assessment will be conducted by outcome evaluators utilizing a set of study instruments, including functionality questionnaires for Activities of Daily Living and Instrumental Activities of Daily Living, Short Physical Performance Battery for evaluating intrinsic functional capacity (focusing on lower limb strength, balance, and gait speed), fall risk assessment, self-perceived health, adverse health outcomes, and a multiprofessional evaluation. Following the initial assessment, participants meeting the inclusion and exclusion criteria will be randomly allocated to the research groups (ViviFrail and CG). Participants in the ViviFrail group will be categorized based on their functional performance, and the most suitable multicomponent exercise passport from the VIVIFRAIL® protocol will be assigned. The training period will span six months, with reassessments every six weeks and a one-week interval for evaluation, resulting in a total duration of seven months. Participants in the ViviFrail group will be instructed to perform home exercises five times a week, with each session lasting 30 to 45 minutes. The researcher will provide exercise passports and facilitate familiarization with the proposed training during weekly meetings at locations designated by the social assistance program in Porto Alegre, or through regular phone contact for monitoring purposes. The CG group will function as the control group, receiving exercise suggestions and guidance on maintaining a healthy routine for three months. Subsequently, they will undergo the VIVIFRAIL® program intervention for an additional three months. The follow-up period will be identical for both groups, with each engaging in eight months of activities.

Conditions

• Frailty
• Aging
• Physical Disability

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-05-28
• Primary completion: 2025-01-31
• Completion: 2025-05-30
• First posted: 2024-02-21
• Last updated: 2024-06-06

Locations

4 sites across 1 country: Brazil