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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05398354
Other study ID # 21040
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date July 30, 2023

Study information

Verified date November 2023
Source University of Évora
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study will include 160 participants. They will be randomized into 2 groups, experimental and control. The intervention will take place over 24 weeks. Parameters of body composition, quality of life, physical activity, strength, flexibility, postural control, gait, agility and execution speed will be determined.


Description:

The intervention study will have a quasi-experimental, longitudinal and controlled design. The sample will participate in a supervised training program lasting 24 weeks, followed by a 1-year follow-up period. The sample will be divided into two groups, intervention group and control group. The variables under study are physical activity in the last week; quality of life; lower and upper limb strength; flexibility of the lower and upper limbs; postural control; march; agility and execution speed. These variables will be evaluated in 4 moments: before the beginning of the training program; after 24 weeks of the program; after 6 months from the end of the program; and after 1 year. A convenience sample will be recruited in the community of Almada, in partnership with the Municipality of Almada (CMA). The sample will be recruited according to the following inclusion criteria: residents in the municipality of Almada, individuals between 55 and 80 years of age, healthy people, who do not have prostheses (with the exception of dental prostheses), who have not undergone operations for over 6 months, and who can walk independently for up to 10 minutes. Participants will not be eligible if they are younger than 55 years of age or older than 80 years of age, have a musculoskeletal or neurological diagnosis and report a clinical cardiovascular diagnosis. Gender is not an exclusion criterion. The training program will be carried out over a period of 24 weeks, with exercise sessions twice a week, lasting approximately 45 minutes each. The sessions were divided into three phases: initial phase; fundamental phase; and return to calm. Throughout the intervention, the sensorimotor training program will have a progressive increase in load, the exercises will be divided into 3 levels of intensity: easy, intermediate and advanced.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date July 30, 2023
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 55 Years to 80 Years
Eligibility Inclusion Criteria: - Aged between 55 years and 80 years; - Agree to participate in the study; - Healthy people; - People without prostheses (with the exception of dental prostheses); - People who have not been operated on for less than 6 months. Exclusion Criteria: - People with musculoskeletal diagnosis; - People with problems in locomotion; - Psychiatric diseases and neurological disorders; - People with a clinical cardiovascular diagnosis.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Active retirement
During the intervention, the sensorimotor training program will have a progressive increase in load, the exercises will be divided into 3 levels of intensity: easy (without external load, during the first 8 weeks), intermediate (application of external load: elastic bands, shin guards and free weights, from the 9th to the 16th week) and advanced (increased external load compared to the previous level, from the 17th to the 24th week). During the sessions we will still assess the intensity through the subjective perception of effort (RPE) scale. In addition, adherence and control of the level of control through the Physical Activity Enjoyment (PACES) survey applied to participants.

Locations

Country Name City State
Portugal Carolina Alexandra Cabo Évora

Sponsors (1)

Lead Sponsor Collaborator
University of Évora

Country where clinical trial is conducted

Portugal, 

References & Publications (16)

Bacha, J. M. R., Cordeiro, L. R., Alvisi, T. C., & Bonfim, T. R. (2016). Impacto do treinamento sensório-motor com plataforma vibratória no equilíbrio e na mobilidade funcional de um indivíduo idoso com sequela de acidente vascular encefálico: Relato de caso. Fisioterapia e Pesquisa, 23(1), 111-116. https://doi.org/10.1590/1809-2950/14362423012016

Costa, J. N., Avelar, B. P., Gonçalves, C. D., & Pereira, M. M. (2012). Efeitos do circuito de equilíbrio sobre o equilíbrio funcional e a possibilidade de quedas em idosas. Motricidade, 8, 485-492.

Gerhardy T, Gordt K, Jansen CP, Schwenk M. Towards Using the Instrumented Timed Up-and-Go Test for Screening of Sensory System Performance for Balance Control in Older Adults. Sensors (Basel). 2019 Feb 1;19(3):622. doi: 10.3390/s19030622. — View Citation

Gléria, P. D. M. P., & Sandoval, R. A. (2011). Treinamento funcional como recurso fisioterapêutico para o aprimoramento da força muscular e equilíbrio de idosos. EFDeportes.com, Revista Digital, 161.

Martins, M. M., Monteiro, C., Martinho, J., Guerra-Martín, M. D., Alves, I., & Vieira, M. (2016). Atividade física nos mais de 65 anos e a Promoção da Saúde. Actas de Gerontologia, 2(1).

McGarrigle L, Boulton E, Todd C. Map the apps: a rapid review of digital approaches to support the engagement of older adults in strength and balance exercises. BMC Geriatr. 2020 Nov 18;20(1):483. doi: 10.1186/s12877-020-01880-6. — View Citation

Pierratos, T., & Polatoglou, H. M. (2020). Utilizing the phyphox app for measuring kinematics variables with a smartphone. Physics Education, 55(2), 025019. https://doi.org/10.1088/1361-6552/ab6951

Ready, E. A. (2019). Optimizing Gait Outcomes in Parkinson's Disease with Auditory Cues: The Effects of Synchronization, Groove, and Beat Perception Ability [The University of Western Ontario]. https://ir.lib.uwo.ca/etd

Rezende, A. A. B., Silva, I. L. e, Beresford, H., & Batista, L. A. (2012). Avaliação dos efeitos de um programa sensório-motor no padrão da marcha de idosas. Fisioterapia em Movimento, 25(2), 317-324. https://doi.org/10.1590/S0103-51502012000200009

Rikli, R. E., & Jones, C. J. (1999). Development and Validation of a Functional Fitness Test for Community-Residing Older Adults. Journal of Aging and Physical Activity, 7(2), 129-161. https://doi.org/10.1123/japa.7.2.129

Rosa, B. P. de. S. (2012). Envelhecimento, Força Muscular e Atividade Física: Uma breve revisão bibliográfica. Revista Científica FacMais, 2(1), 140-152.

Salehi, R., Ebrahimi-Takamjani, I., Esteki, A., Maroufi, N., & Parnianpour, M. (2010). Test-retest reliability and minimal detectable change for center of pressure measures of postural stability in elderly subjects. Medical Journal of the Islamic Republic of Iran, 23(4), 224-232.

Sampaio, L. V. P., Castilho, L. B., & Carvalho, G. de A. (2017). Development of an application for mobile devices to evaluate the balance and risk of falls of the elderly. Revista Brasileira de Geriatria e Gerontologia, 20(6), 805-813. https://doi.org/10.1590/1981-22562017020.170017

Serviço Nacional de Saúde. (2017). Tropeções, quedas e trambolhões. https://www.sns.gov.pt/noticias/2017/12/19/tropecoes-quedas-e-trambolhoes/

Serviço Nacional de Saúde. (2018). Portal da Direção Nacional de Saúde. https://www.dgs.pt/programa-nacional-para-a-promocao-da-atividade-fisica/perguntas-e-respostas.aspx

Suzuki, K., Niitsu, M., Kamo, T., Otake, S., & Nishida, Y. (2019). Effect of Exercise with Rhythmic Auditory Stimulation on Muscle Coordination and Gait Stability in Patients with Diabetic Peripheral Neuropathy: A Randomized Controlled Trial. Open Journal of Therapy and Rehabilitation, 07(03), 79-91. https://doi.org/10.4236/ojtr.2019.73005

* Note: There are 16 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight Weight evaluation will be done using a scale 1 year
Primary Height Height evaluation will be done using a stadiometer 1 year
Primary Lower limbs muscle strength Lower limbs muscle strength will be evaluated with chair stand-up test 1 year
Primary Upper limbs muscle strength The muscle strength of the upper limbs will be evaluated by forearm flexion test 1 year
Primary Lower limbs flexibility Lower limbs flexibility will be evaluated through the "sit and reach" 1 year
Primary Upper limbs flexibility The flexibility of the upper limbs will be assessed through "reaching behind the back" 1 year
Primary Postural control Postural control will be assessed using a force platform (Bertec4060-Columbus; USA). The evaluation will consist of measuring the oscillations in a static bipedal position, with eyes open (2 minutes) and with eyes closed (2 minutes). 1 year
Primary Gait Gait will be evaluated using the mobile application "phyphox" on the inner edge of the tibia, on the surface of the skin, to quantify the number of steps and time), participants will be asked to walk a pre-established route, without slopes or obstacles, for 10 minutes at its natural cadence and then the same route at a rhythm determined by complex stimuli (auditory metronome - loudspeakers, which allow you to hear the beats, where each beat corresponds to a step) 1 year
Primary Agility and execution speed Agility and speed of execution will be evaluated through the application of the Timed Up and Go (TUG) test, which consists of getting up from a chair, walking to a straight line 3 meters away, turning, walking back and sitting down again. 1 year
Secondary Life Quality Quality of life will be assessed using the general health and well-being questionnaire. The questionnaire consists of 11 questions ranging from 1 to 5, where 1 is absolutely true and 5 is absolutely false. 1 year
Secondary Physical activity level The practice of physical activity will be evaluated through the International Physical Activity Questionnaire. It does not have minimum and maximum values, the participants only indicate if they take place and in what period of time. 1 year
Secondary Effort intensity Intensity of effort will be evaluated through the subjective perception of exertion scale. The scale goes from 1 to 10 values, and the closer to 10 the activity requires maximum effort, it seems almost impossible to continue. 1 year
Secondary Level of satisfaction The level of satisfaction will be evaluated through the Physical Activity Enjoyment Scale. Scale from 1 to 7 values, the closer to 7 the more positive the physical activity. 1 year
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