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Multicomponent exercises in older adults - VIVIFRAIL®

Effect of multicomponent exercises on the intrinsic functional capacity of older adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2tq2jky
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-03-25
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aging

Interventions

This is a randomized, controlled, matched, and single-blind clinical trial. Participants will be men and women of all genders, aged 60 or older. After the initial assessment, they will be randomly div
G11.427.410.698.277

Sponsors

Pontifícia Universidade Católica do Rio Grande do Sul
Lead Sponsor
Fundação de Assistência Social e Cidadania- FASC
Collaborator

Eligibility

Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Older individuals of both genders; aged at least 60; who regularly attend meetings of elderly groups at the Foundation of Social Assistance and Citizenship; who do not have severe visual, auditory, or cognitive impairment that would hinder the safe completion of the proposed assessments or exercises

Exclusion criteria

Exclusion criteria: Participants who have surgeries or scheduled procedures in the next eight months that would prevent them from participating in the exercise program; participants who cannot remain seated without support for at least 10 minutes during the functional assessment; participants who, during the cognitive assessment, demonstrate an inability to respond to verbal commands; exclusion criteria for the VIVIFRAIL® exercise protocol: Acute myocardial infarction or recent unstable angina within 6 months; recent report of uncontrolled atrial or ventricular arrhythmias within 30 days; history of dissecting aortic aneurysm; severe aortic stenosis; acute endocarditis/pericarditis; uncontrolled high blood pressure; 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 circumstance that is considered a hindrance or risk for engaging in physical activity

Design outcomes

Primary

MeasureTime frame
It is expected to observe an improvement in intrinsic functional capacity from baseline (start of intervention) to the end of the six-month intervention, as assessed by the Short Physical Performance Battery, which 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 in the Short Physical Performance Battery

Secondary

MeasureTime frame
We anticipate observing an improvement in basic activities of daily living, assessed through the Integrated care for older people - ICOPE Functional Ability questionnaire (21 points: independent); and the Barthel Index (14.8 seconds;We expect to observe improvement in balance, assessed through the tests of standing with one foot in front of the other, semi-tandem, and tandem positions (0 to 4 points). A change of 1 point in the test will be considered an improvement in balance;We expect to observe a change in self-perceived health ('very poor', 'poor', 'fair', 'good', and 'excellent');We anticipate observing changes in health adverse outcomes: falls in the 'last three months' ('Yes'; 'No'), hospitalization, and institutionalization

Countries

Brazil

Contacts

Public ContactÂngelo Bós

Pontifícia Universidade Católica do Rio Grande do Sul

angelo.bos@pucrs.br+55-51-33203829

Outcome results

None listed

Source: REBEC (via WHO ICTRP)