Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial.
Álvaro Casas-Herrero, Mikel L Sáez de Asteasu, Iván Antón-Rodrigo...
https://pubmed.ncbi.nlm.nih.gov/35150086Actively Recruiting
Phase Not Applicable
Age: 60Years +
All Genders
Healthy Volunteers
ID06271239
Effect of Multicomponent Exercises on the Intrinsic Functional Capacity of Older Adults
Led by Pontificia Universidade Católica do Rio Grande do Sul · Updated on 2024-06-06
50
Participants Needed
4
Research Sites
17 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
Researchers are evaluating the effects of a multicomponent physical exercise program called VIVIFRAIL® on the functional abilities of older adults aged 60 and above. This randomized, controlled, paired, single-blind clinical trial includes men and women enrolled in senior groups within a social assistance program. The study aims to examine how tailored exercises impact daily living activities, physical performance, fall risk, and overall health outcomes in this population. Participants are randomly assigned to two groups. The Intervention Group follows a personalized VIVIFRAIL® home exercise routine five times a week for six months, with sessions lasting 30 to 45 minutes and reassessments every six weeks. The Control Group receives healthy lifestyle guidance and exercise suggestions for three months, then begins the VIVIFRAIL® program for the following three months. Both groups are monitored throughout, with the total study period lasting around seven months. During the study, participants undergo evaluations including questionnaires on daily activities, physical performance batteries assessing strength, balance, and walking speed, and assessments of falls, health perception, and hospitalizations. Adherence is tracked through activity diaries and regular contact with researchers. The primary outcome measured is the short physical performance battery, with secondary measures covering various functional and health indicators. Monitoring continues through study completion, averaging one year from the start.
CONDITIONS
Brief Title
Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
Who Can Participate
Age: 60Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 60 years or older
- Both men and women
- Actively participate in regular meetings of elderly groups 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 prevent participation in the exercise program
- Unable to sit unsupported for at least 10 minutes or unable to respond to verbal commands during assessment
- Recent acute myocardial infarction or unstable angina within 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 or uncontrolled hypoglycemia
- Recent fracture within the last month
- Any other condition considered risky or prohibitive for physical activity participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Intervention
Duration - 7 months
Participants in the Intervention Group will perform home-based multicomponent exercises from the VIVIFRAIL® protocol five times a week, 30 to 45 minutes per session, for six months with a one-week break every six weeks for reassessment. Participants in the Control Group will receive exercise guidance for three months, then start the VIVIFRAIL® exercise program for three months.
Weekly visits or phone contacts for monitoring and reassessment every six weeks
Follow-up
Duration - Up to 1 year from study start
Participants continue activities and monitoring as assigned, with ongoing assessments of functional capacity and health outcomes.
Periodic assessments throughout the study
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
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Research Team
A
Angelo Bós, Phd
A
Ana Paula Tiecker, MsC
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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Eduardo L Cadore, Alvaro Casas-Herrero, Fabricio Zambom-Ferraresi...
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Nicolás Martínez-Velilla, Alvaro Casas-Herrero, Fabrício Zambom-Ferraresi...
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Juan Luis Sánchez-Sánchez, Philipe de Souto Barreto, Iván Antón-Rodrigo...
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Javier Courel-Ibáñez, Ángel Buendía-Romero, Jesús G Pallarés...
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Ofer Kis, Assaf Buch, Naftali Stern...
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Leocadio Rodriguez-Mañas, Linda P Fried
https://pubmed.ncbi.nlm.nih.gov/25468154International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines.
M Izquierdo, R A Merchant, J E Morley...
https://pubmed.ncbi.nlm.nih.gov/34409961