NCT06271239 Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
| NCT ID | NCT06271239 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pontificia Universidade Católica do Rio Grande do Sul |
| Condition | Frailty |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-05-28 |
| Primary Completion | 2025-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-05-28 with a primary completion date of 2025-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Exclusion criteria specific to the VIVIFRAIL® exercise protocol include: * Recent acute myocardial infarction or unstable angina within 6 months * History of uncontrolled arrhythmias * Dissecting aortic aneurysm * Severe aortic stenosis * Acute endocarditis/pericarditis * Uncontrolled hypertension * Acute thromboembolic disease * Severe acute heart failure * Severe acute respiratory failure * Uncontrolled orthostatic hypotension * Acute decompensation of diabetes mellitus or uncontrolled hypoglycemia * Recent fracture within the last month * Any other circumstances deemed prohibitive or risky for engaging in physical activity are also grounds for exclusion.
Contact & Investigator
Angelo Bós, Phd
PRINCIPAL INVESTIGATOR
Pontificia Universidade Católica do Rio Grande do Sul
Frequently Asked Questions
Who can join the NCT06271239 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06271239 currently recruiting?
Yes, NCT06271239 is actively recruiting participants. Contact the research team at angelo.bos@pucrs.br for enrollment information.
Where is the NCT06271239 trial being conducted?
This trial is being conducted at Porto Alegre, Brazil, Porto Alegre, Brazil, Porto Alegre, Brazil, Porto Alegre, Brazil.
Who is sponsoring the NCT06271239 clinical trial?
NCT06271239 is sponsored by Pontificia Universidade Católica do Rio Grande do Sul. The principal investigator is Angelo Bós, Phd at Pontificia Universidade Católica do Rio Grande do Sul. The trial plans to enroll 50 participants.