Actively Recruiting
Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
Led by Pontificia Universidade Católica do Rio Grande do Sul · Updated on 2024-06-06
50
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
P
Pontificia Universidade Católica do Rio Grande do Sul
Lead Sponsor
C
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 60 years and older of any gender
- Actively participate in regular elderly group meetings within the social assistance program in Porto Alegre
- No severe visual, hearing, or cognitive impairments that prevent safe completion of assessments or exercises
You will not qualify if you...
- Scheduled surgeries or procedures in the next eight months that impede exercise participation
- Unable to sit unsupported for at least 10 minutes during assessment
- Unable to respond to verbal commands during cognitive assessment
- Acute myocardial infarction or unstable angina within last 6 months
- History of uncontrolled arrhythmias
- Dissecting aortic aneurysm
- Severe aortic stenosis
- Acute endocarditis or 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 conditions that make physical activity unsafe or risky
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Trial Site Locations
Total: 4 locations
1
Industrial Retirement and Pension Institute (IAPI)
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
2
The First of May Community Center (CEPRIMA)
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
3
The Older Adult Day Center (CDI)
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
4
The Vila Floresta Community Center (CECOFLOR)
Porto Alegre, Rio Grande do Sul, Brazil
Actively Recruiting
Research Team
A
Angelo Bós, Phd
CONTACT
A
Ana Paula Tiecker, MsC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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