Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults

Pontificia Universidade Católica do Rio Grande do Sul

Status: Enrolling

Conditions: Aging; Physical Disability; Frailty

Treatments: Other: Group Suggestions for a Healthy Life (CG); Other: Intervention group (ViviFrail)

Study type: Interventional

Funder types: Other

Identifiers

NCT06271239

U1111-1299-9167

65318722.0.0000.5336 (Other Identifier)

RBR-2tq2jky (Other Identifier)

Details and patient eligibility

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.
• Exclusion criteria specific to the VIVIFRAIL® exercise protocol include:
• 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
• Any other circumstances deemed prohibitive or risky for engaging in physical activity are also grounds for exclusion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Intervention group (ViviFrail)

Experimental group

Description:

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.

Treatment:

Other: Intervention group (ViviFrail)

Group Suggestions for a Healthy Life (CG)

Active Comparator group

Description:

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.

Treatment:

Other: Group Suggestions for a Healthy Life (CG)