Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
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
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
Treatments tested in this trial
- Intervention group (ViviFrail)
- Group Suggestions for a Healthy Life (CG)
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Pontificia Universidade Católica do Rio Grande do Sul
Lead sponsor
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborator
Source ClinicalTrials.gov