Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
3 other identifiers
interventional
50
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2024
CompletedFirst Posted
Study publicly available on registry
February 21, 2024
CompletedStudy Start
First participant enrolled
May 28, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2025
CompletedJune 6, 2024
June 1, 2024
8 months
January 24, 2024
June 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short physical performance battery
It's expected to observe an improvement in intrinsic functional capacity from baseline (start of intervention) to the end of the six-month intervention, as evaluated by the Short physical performance battery. This assessment 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 on the Short physical performance battery.
through study completion, an average of 1 year
Secondary Outcomes (10)
Barthel Index
through study completion, an average of 1 year
ICOPE questionnaire
through study completion, an average of 1 year
Lawton Scale
through study completion, an average of 1 year
4-meter gait speed
through study completion, an average of 1 year
Five Times Sit-to-Stand
through study completion, an average of 1 year
- +5 more secondary outcomes
Study Arms (2)
Intervention group (ViviFrail)
EXPERIMENTALIntervention Group: 25 participants will be guided to perform one of the home-based exercise programs from the VIVIFRAIL® protocol, tailored to their clinical conditions and functional capacity.
Group Suggestions for a Healthy Life (CG)
ACTIVE COMPARATORThe control group, also consisting of 25 participants, will receive exercise suggestions and guidance on maintaining a healthy routine for three months. Subsequently, the participants will undergo the intervention with the VIVIFRAIL® program for three months.
Interventions
The participant will be guided to follow a daily exercise routine at home, lasting 30-45 minutes, from Monday to Friday, over six months. A one-week break every six weeks for reassessment, totaling seven months of activities, will be provided. They will be informed that every six weeks, they may receive new exercises in their exercise passport or continue with the same, based on their physical reassessment. Each exercise passport will have a wheel illustrating the exercise circuit for easy reference. An 'Activity Diary' will be provided for tracking progress and frequency. During 'CIRCUIT' sessions, participants should complete the entire circuit, while 'WALKING' sessions should focus solely on walking for that day. They will be motivated to keep this diary updated. The ViviFrail exercise passports cater to various levels of physical frailty and fall risk and can be accessed at https://vivifrail.com/en/materials-2/.
The participants in the group Suggestions for a healthy life (CG) will receive guidance on maintaining a healthy and independent lifestyle for three months. They will also be provided with a booklet containing strength, balance, and flexibility activities, suggesting that participants perform these activities five times a week, for around 30 minutes per day. At the end of the initial three complete months of the intervention (14 weeks), participants in the control group will commence the ViviFrail exercise protocol and will continue until the end of the study. Throughout the entire study period, participants in the control group will receive the same monitoring as the intervention group.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Industrial Retirement and Pension Institute (IAPI)
Porto Alegre, Rio Grande do Sul, Brazil
The First of May Community Center (CEPRIMA)
Porto Alegre, Rio Grande do Sul, Brazil
The Older Adult Day Center (CDI)
Porto Alegre, Rio Grande do Sul, Brazil
The Vila Floresta Community Center (CECOFLOR)
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (9)
Casas-Herrero A, Saez de Asteasu ML, Anton-Rodrigo I, Sanchez-Sanchez JL, Montero-Odasso M, Marin-Epelde I, Ramon-Espinoza F, Zambom-Ferraresi F, Petidier-Torregrosa R, Elexpuru-Estomba J, Alvarez-Bustos A, Galbete A, Martinez-Velilla N, Izquierdo M. Effects of Vivifrail multicomponent intervention on functional capacity: a multicentre, randomized controlled trial. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):884-893. doi: 10.1002/jcsm.12925. Epub 2022 Feb 11.
PMID: 35150086BACKGROUNDCasas-Herrero A, Anton-Rodrigo I, Zambom-Ferraresi F, Saez de Asteasu ML, Martinez-Velilla N, Elexpuru-Estomba J, Marin-Epelde I, Ramon-Espinoza F, Petidier-Torregrosa R, Sanchez-Sanchez JL, Ibanez B, Izquierdo M. Effect of a multicomponent exercise programme (VIVIFRAIL) on functional capacity in frail community elders with cognitive decline: study protocol for a randomized multicentre control trial. Trials. 2019 Jun 17;20(1):362. doi: 10.1186/s13063-019-3426-0.
PMID: 31208471BACKGROUNDCadore EL, Casas-Herrero A, Zambom-Ferraresi F, Idoate F, Millor N, Gomez M, Rodriguez-Manas L, Izquierdo M. Multicomponent exercises including muscle power training enhance muscle mass, power output, and functional outcomes in institutionalized frail nonagenarians. Age (Dordr). 2014 Apr;36(2):773-85. doi: 10.1007/s11357-013-9586-z. Epub 2013 Sep 13.
PMID: 24030238BACKGROUNDMartinez-Velilla N, Casas-Herrero A, Zambom-Ferraresi F, Suarez N, Alonso-Renedo J, Contin KC, de Asteasu ML, Echeverria NF, Lazaro MG, Izquierdo M. Functional and cognitive impairment prevention through early physical activity for geriatric hospitalized patients: study protocol for a randomized controlled trial. BMC Geriatr. 2015 Sep 15;15:112. doi: 10.1186/s12877-015-0109-x.
PMID: 26374430BACKGROUNDSanchez-Sanchez JL, de Souto Barreto P, Anton-Rodrigo I, Ramon-Espinoza F, Marin-Epelde I, Sanchez-Latorre M, Moral-Cuesta D, Casas-Herrero A. Effects of a 12-week Vivifrail exercise program on intrinsic capacity among frail cognitively impaired community-dwelling older adults: secondary analysis of a multicentre randomised clinical trial. Age Ageing. 2022 Dec 5;51(12):afac303. doi: 10.1093/ageing/afac303.
PMID: 36580558BACKGROUNDCourel-Ibanez J, Buendia-Romero A, Pallares JG, Garcia-Conesa S, Martinez-Cava A, Izquierdo M. Impact of Tailored Multicomponent Exercise for Preventing Weakness and Falls on Nursing Home Residents' Functional Capacity. J Am Med Dir Assoc. 2022 Jan;23(1):98-104.e3. doi: 10.1016/j.jamda.2021.05.037. Epub 2021 Jun 29.
PMID: 34197791BACKGROUNDKis O, Buch A, Stern N, Moran DS. Minimally supervised home-based resistance training and muscle function in older adults: A meta-analysis. Arch Gerontol Geriatr. 2019 Sep-Oct;84:103909. doi: 10.1016/j.archger.2019.103909. Epub 2019 Jul 8.
PMID: 31301519BACKGROUNDRodriguez-Manas L, Fried LP. Frailty in the clinical scenario. Lancet. 2015 Feb 14;385(9968):e7-e9. doi: 10.1016/S0140-6736(14)61595-6. Epub 2014 Nov 6. No abstract available.
PMID: 25468154BACKGROUNDIzquierdo M, Merchant RA, Morley JE, Anker SD, Aprahamian I, Arai H, Aubertin-Leheudre M, Bernabei R, Cadore EL, Cesari M, Chen LK, de Souto Barreto P, Duque G, Ferrucci L, Fielding RA, Garcia-Hermoso A, Gutierrez-Robledo LM, Harridge SDR, Kirk B, Kritchevsky S, Landi F, Lazarus N, Martin FC, Marzetti E, Pahor M, Ramirez-Velez R, Rodriguez-Manas L, Rolland Y, Ruiz JG, Theou O, Villareal DT, Waters DL, Won Won C, Woo J, Vellas B, Fiatarone Singh M. International Exercise Recommendations in Older Adults (ICFSR): Expert Consensus Guidelines. J Nutr Health Aging. 2021;25(7):824-853. doi: 10.1007/s12603-021-1665-8.
PMID: 34409961BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Angelo Bós, Phd
Pontificia Universidade Católica do Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- The assessments will be conducted by trained researchers
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor at school of medicine
Study Record Dates
First Submitted
January 24, 2024
First Posted
February 21, 2024
Study Start
May 28, 2024
Primary Completion
January 31, 2025
Study Completion
May 30, 2025
Last Updated
June 6, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- five years
- Access Criteria
- Send an email to the research lead
Each participant will be assigned a sequential Arabic number for identification. In all databases shared with individuals not directly involved in the research, these numbers will be used as identifiers, replacing personal information such as parts of the name, address, phone numbers, and names of family members/caregivers. All data will be available for five years to any readers of the article interested in conducting secondary analyses, provided they submit a proposal that does not compromise the authors' future publication interests. Requests should be sent to the corresponding author via email, and the data will be made available in an Excel spreadsheet. Additional documents will be available for five years from the publication date, including the study protocol and the data request form.