Clinical trial NCT06271239: Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults
Official title: Effect of Multicomponent Exercises on the Intrinsic Functional Capacity of Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Aging
Physical Disability
Keywords: Aging
Public Health
Frailty
Exercise
Lead sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2024-02-21
Enrollment: 50
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In the Intervention Group (ViviFrail), participants will perform a six-month VIVIFRAIL® protocol-based exercise, adapted to their clinical profile.

The Group Suggestions for a Healthy Life (CG) will receive exercise suggestions and guidance for maintaining a healthy routine for three months. After, they will undergo a three-month intervention using the VIVIFRAIL® protocol.

Sample size determination was based on Casas-Herrero et al. (2022). The study assessed the impact of multicomponent training on intrinsic functional capacity, utilizing the Short Physical Performance Battery (SPPB) to gauge balance, gait speed, and lower limb strength on a 0 to 12 scale. Control group: -0.33±1.60 point difference; Treatment group: 1.07±1.52 point difference.

Considering a 5% alpha and 80% power, 20 participants per group are required. Anticipating a 25% dropout rate, as observed by Tiecker (2021), we plan to enroll 25 participants per group.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Short physical performance battery
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Barthel Index
timeFrame: through study completion, an average of 1 year
measure: ICOPE questionnaire
timeFrame: through study completion, an average of 1 year
measure: Lawton Scale
timeFrame: through study completion, an average of 1 year
measure: 4-meter gait speed
timeFrame: through study completion, an average of 1 year
measure: Five Times Sit-to-Stand
timeFrame: through study completion, an average of 1 year
measure: Balance test in three positions
timeFrame: through study completion, an average of 1 year
measure: Self-perceived health
timeFrame: through study completion, an average of 1 year
measure: Adverse health outcomes - falls
timeFrame: through study completion, an average of 1 year
measure: Adverse health outcomes - hospitalization
timeFrame: through study completion, an average of 1 year
measure: Adverse health outcomes - institutionalization
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Industrial Retirement and Pension Institute (IAPI)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: The First of May Community Center (CEPRIMA)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: The Older Adult Day Center (CDI)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: The Vila Floresta Community Center (CECOFLOR)
state: Rio Grande Do Sul
Study officials:
affiliation: Pontificia Universidade Católica do Rio Grande do Sul
name: Angelo Bós, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Casas-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.
citation: Cadore 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.
citation: Martinez-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.
citation: Sanchez-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.
citation: Courel-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.
citation: Kis 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.
citation: Rodriguez-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.
citation: Izquierdo 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.