Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults

ConditionsFrailty Aging Physical Disability

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorPontificia Universidade Católica do Rio Grande do Sul

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Eligible participants are older adults of both genders, aged at least 60 years.

Participants must be actively participating in regular meetings of elderly groups within the social assistance program in Porto Alegre.

Participants should not have severe visual, hearing, or cognitive impairments that could impede the safe completion of proposed assessments or exercises

Disqualifiers

Participants with scheduled surgeries or procedures within the next eight months hindering engagement in the exercise program are excluded.

Those unable to sit unsupported for at least 10 minutes during the functional assessment or demonstrating an inability to respond to verbal commands in the cognitive assessment are excluded.

Recent acute myocardial infarction or unstable angina within 6 months

History of uncontrolled arrhythmias

Trial design

Design model

Parallel

Treatments tested in this trial

Intervention group (ViviFrail)
Other intervention
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/.
Group Suggestions for a Healthy Life (CG)
Other intervention
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.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Intervention group (ViviFrail)Experimental treatment 1 intervention

Group B: Group Suggestions for a Healthy Life (CG)Active comparator 1 intervention

Trial outcomes

Primary outcomes

Short physical performance battery

It's expected to observe an improvement in intrinsic functional capacity from baseline (start of intervention) to the end of the six-month intervention, as evaluated by the Short physical performance battery. This assessment combines balance, gait speed, and lower limb strength into a single score ranging from 0 (worst) to 12 (best). A clinically significant change will be considered as a 1-point change on the Short physical performance battery.

Time frame