Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06271239
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-01-24
Brief Title:
Effect of Multicomponent Exercises VIVIFRAIL in Older Adults
Sponsor:
Pontificia Universidade Católica do Rio Grande do Sul
Organization:
Pontificia Universidade Católica do Rio Grande do Sul
Study Overview
Official Title:
Effect of Multicomponent Exercises on the Intrinsic Functional Capacity of Older Adults
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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
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
Detailed Description:
Objective This study aims to assess the impact of a multicomponent physical exercise intervention on the intrinsic functional capacity of older adults Methodology A randomized controlled paired single-blind clinical trial will be conducted Participants aged 60 years or older will be randomly assigned to either the Intervention Group ViviFrail or the Group Suggestions for a Healthy Life CG The study sample will consist of older individuals both men and women enrolled in the senior groups of the social assistance program administered by the City Hall of Porto Alegre
The initial assessment will be conducted by outcome evaluators utilizing a set of study instruments including functionality questionnaires for Activities of Daily Living and Instrumental Activities of Daily Living Short Physical Performance Battery for evaluating intrinsic functional capacity focusing on lower limb strength balance and gait speed fall risk assessment self-perceived health adverse health outcomes and a multiprofessional evaluation
Following the initial assessment participants meeting the inclusion and exclusion criteria will be randomly allocated to the research groups ViviFrail and CG Participants in the ViviFrail group will be categorized based on their functional performance and the most suitable multicomponent exercise passport from the VIVIFRAIL protocol will be assigned The training period will span six months with reassessments every six weeks and a one-week interval for evaluation resulting in a total duration of seven months
Participants in the ViviFrail group will be instructed to perform home exercises five times a week with each session lasting 30 to 45 minutes The researcher will provide exercise passports and facilitate familiarization with the proposed training during weekly meetings at locations designated by the social assistance program in Porto Alegre or through regular phone contact for monitoring purposes
The CG group will function as the control group receiving exercise suggestions and guidance on maintaining a healthy routine for three months Subsequently they will undergo the VIVIFRAIL program intervention for an additional three months The follow-up period will be identical for both groups with each engaging in eight months of activities
The initial assessment will be conducted by outcome evaluators utilizing a set of study instruments including functionality questionnaires for Activities of Daily Living and Instrumental Activities of Daily Living Short Physical Performance Battery for evaluating intrinsic functional capacity focusing on lower limb strength balance and gait speed fall risk assessment self-perceived health adverse health outcomes and a multiprofessional evaluation
Following the initial assessment participants meeting the inclusion and exclusion criteria will be randomly allocated to the research groups ViviFrail and CG Participants in the ViviFrail group will be categorized based on their functional performance and the most suitable multicomponent exercise passport from the VIVIFRAIL protocol will be assigned The training period will span six months with reassessments every six weeks and a one-week interval for evaluation resulting in a total duration of seven months
Participants in the ViviFrail group will be instructed to perform home exercises five times a week with each session lasting 30 to 45 minutes The researcher will provide exercise passports and facilitate familiarization with the proposed training during weekly meetings at locations designated by the social assistance program in Porto Alegre or through regular phone contact for monitoring purposes
The CG group will function as the control group receiving exercise suggestions and guidance on maintaining a healthy routine for three months Subsequently they will undergo the VIVIFRAIL program intervention for an additional three months The follow-up period will be identical for both groups with each engaging in eight months of activities
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 65318722000005336 | OTHER | None | None |
| RBR-2tq2jky | OTHER | The Brazilian Registry of Clinical Trials ReBEC | None |