Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults

February 14, 2024 updated by: Ângelo José Gonçalves Bós, Pontificia Universidade Católica do Rio Grande do Sul

Effect of Multicomponent Exercises on the Intrinsic Functional Capacity of Older Adults

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group (ViviFrail)
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 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/.
Active Comparator: Group Suggestions for a Healthy Life (CG)
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short physical performance battery
Time Frame: through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Barthel Index
Time Frame: through study completion, an average of 1 year
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).
through study completion, an average of 1 year
ICOPE questionnaire
Time Frame: through study completion, an average of 1 year
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).
through study completion, an average of 1 year
Lawton Scale
Time Frame: through study completion, an average of 1 year
Improvement is expected to be observed in instrumental activities of daily living (IADL), assessed through the Lawton Scale (27 points: independent)
through study completion, an average of 1 year
4-meter gait speed
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Five Times Sit-to-Stand
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Balance test in three positions
Time Frame: through study completion, an average of 1 year
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.
through study completion, an average of 1 year
Self-perceived health
Time Frame: through study completion, an average of 1 year
It's expected to observe a change in self-perceived health ("very poor", "poor", "fair", "good", and "excellent")
through study completion, an average of 1 year
Adverse health outcomes - falls
Time Frame: through study completion, an average of 1 year
It's expected to observe changes in adverse health outcomes: falls in the "last three months" ("Yes"; "No")
through study completion, an average of 1 year
Adverse health outcomes - hospitalization
Time Frame: through study completion, an average of 1 year
It's expected to observe changes in adverse health outcomes: hospitalization in the "last three months" ("Yes"; "No")
through study completion, an average of 1 year
Adverse health outcomes - institutionalization
Time Frame: through study completion, an average of 1 year
It's expected to observe changes in adverse health outcomes: institutionalization in the "last three months" ("Yes"; "No")
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidade Católica do Rio Grande do Sul

Collaborators

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

Investigators

  • Principal Investigator: Angelo Bós, Phd, Pontificia Universidade Católica do Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 14, 2024

First Posted (Estimated)

February 21, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 14, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1299-9167
  • 65318722.0.0000.5336 (Other Identifier: IRB-Pontifical Catholic University of Rio Grande do Sul)
  • RBR-2tq2jky (Other Identifier: The Brazilian Registry of Clinical Trials (ReBEC))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

five years

IPD Sharing Access Criteria

Send an email to the research lead

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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