An interventional study of Intervention group (ViviFrail) and Group Suggestions for a Healthy Life (CG) in Frailty, Aging and Physical Disability, sponsored by Pontificia Universidade Católica do Rio Grande do Sul. Recruiting at 4 sites in Brazil. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-06.
Sponsored by Pontificia Universidade Católica do Rio Grande do Sul · Not applicable, Interventional, and Prevention
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.
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.
1,284 studies on the registry are indexed under Frailty; 452 are open to participants now.
This study's planned enrollment of 50 is below the median of 81 across 767 interventional studies indexed under Frailty.
Browse Frailty studies →Pontificia Universidade Católica do Rio Grande do Sul is the lead sponsor of 23 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Intervention 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.
Other: Intervention group (ViviFrail)
The 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.
Other: Group Suggestions for a Healthy Life (CG)
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.
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.
Time frame: through study completion, an average of 1 year
Barthel Index
It is expected to observe improvement in basic activities of daily living (ADL), assessed through the Barthel Index (\<20 total dependence; 20-35 severe dependence; 40-55 moderate dependence; ≥60 mild dependence; 100 Independent).
Time frame: through study completion, an average of 1 year
ICOPE questionnaire
It is expected to observe improvement in basic activities of daily living (ADL), assessed through the Integrated care for older people (ICOPE) Functional Ability questionnaire (21 points: independent).
Time frame: through study completion, an average of 1 year
Lawton Scale
Improvement is expected to be observed in instrumental activities of daily living (IADL), assessed through the Lawton Scale (27 points: independent)
Time frame: through study completion, an average of 1 year
4-meter gait speed
An improvement in walking time in the 4-meter gait speed test is expected, where a change of 0.1 m/s is considered clinically relevant.
Time frame: through study completion, an average of 1 year
Five Times Sit-to-Stand
Improvement in the performance of the Five Times Sit-to-Stand Test is expected. Good performance will be considered if the participant completes it in ≤14.8 seconds, and poor performance if it's \>14.8 seconds.
Time frame: through study completion, an average of 1 year
Balance test in three positions
Improvement in balance (0 to 4 points) is expected, determined through tests involving standing with one foot in front of the other, in a semi-tandem position, and in a tandem position. A change of 1 point in the test will be considered an improvement in balance.
Time frame: through study completion, an average of 1 year
Self-perceived health
It's expected to observe a change in self-perceived health ("very poor", "poor", "fair", "good", and "excellent")
Time frame: through study completion, an average of 1 year
Adverse health outcomes - falls
It's expected to observe changes in adverse health outcomes: falls in the "last three months" ("Yes"; "No")
Time frame: through study completion, an average of 1 year
Adverse health outcomes - hospitalization
It's expected to observe changes in adverse health outcomes: hospitalization in the "last three months" ("Yes"; "No")
Time frame: through study completion, an average of 1 year
Adverse health outcomes - institutionalization
It's expected to observe changes in adverse health outcomes: institutionalization in the "last three months" ("Yes"; "No")
Time frame: through study completion, an average of 1 year
Plan to share: Yes — 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.
Supporting information: Study protocol, Informed consent form
Time frame: five years
Access criteria: Send an email to the research lead
Started May 2024 (actual). Primary completion is estimated for Jan 2025, 8 months after the start.
Of 513 non-industry interventional studies with no phase under Frailty, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 8 months is below that.
Counting every sponsor, half of 517 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
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Pontificia Universidade Católica do Rio Grande do Sul