Effect of Multicomponent Exercises VIVIFRAIL® in Older Adults

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06271239
• Other study ID #: U1111-1299-9167
• Secondary ID: 65318722.0.0000.
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 15, 2024
• Est. completion date: March 30, 2025

Study information

• Verified date: February 2024
• Source: Pontificia Universidade Católica do Rio Grande do Sul
• Contact: Angelo Bós, Phd
• Phone: +5551998453644
• Email: angelo.bos[@]pucrs.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aging
• Frailty
• Physical Disability

Intervention

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/.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidade Católica do Rio Grande do Sul	Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Erratum In: Age Ageing. 2023 Apr 1;52(4): — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	through study completion, an average of 1 year
Secondary	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).	through study completion, an average of 1 year
Secondary	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).	through study completion, an average of 1 year
Secondary	Lawton Scale	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
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	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.	through study completion, an average of 1 year
Secondary	Self-perceived health	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
Secondary	Adverse health outcomes - falls	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
Secondary	Adverse health outcomes - hospitalization	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
Secondary	Adverse health outcomes - institutionalization	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

External Links

•   Projeto VIVIFRAIL
•   Tiecker, 2021