Public trial
RBR-5w67pz4 Effect of physiotherapy with muscle strength, balance and walking training in elderly women with and without Knee arthro...
Date of registration: 08/04/2021 (mm/dd/yyyy)Last approval date : 08/04/2021 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Effect of Therapeutic Intervention with muscle resistance training, balance and gait with visual feedback in elderly women with and without Knee Osteoarthritis: randomized clinical trial
pt-br
Efeito da Intervenção Terapêutica com treino de resistência muscular, equilíbrio e marcha com feedback visual em Idosas com e sem Osteoartrite de Joelho: ensaio clínico randomizado
es
Effect of Therapeutic Intervention with muscle resistance training, balance and gait with visual feedback in elderly women with and without Knee Osteoarthritis: randomized clinical trial
Trial identification
- UTN code:
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Public title:
en
Effect of physiotherapy with muscle strength, balance and walking training in elderly women with and without Knee arthrosis
pt-br
Effect of physical therapy with muscle strength, balance and walking training with visual stimulation in elderly women with and without knee arthrosis
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Scientific acronym:
en
Therapeutic training with muscle resistance exercises, balance and gait with visual feedback in elderly women with and without Knee Osteoarthritis: a randomized clinical trial
pt-br
Treino terapêutico com exercícios de resistência muscular, equilíbrio e marcha com feedback visual em idosas com e sem osteoartrite de joelho: ensaio clínico randomizado
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Public acronym:
en
Knee Osteoarthritis
pt-br
Osteoartrite de joelho
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Secondaries identifiers:
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33502520.8.0000.0081
Issuing authority: Plataforma Brasil
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4.091.004
Issuing authority: Comitê de Ética em Pesquisa da Universidade Santo Amaro
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33502520.8.0000.0081
Sponsors
- Primary sponsor: University Santo Amaro
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Secondary sponsor:
- Institution: University of São Paulo
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Supporting source:
- Institution: University Santo Amaro
Health conditions
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Health conditions:
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Gonarthrosis; knee arthrosis
pt-br
Gonartrose; artrose do joelho
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General descriptors for health conditions:
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C05.550.114.606 Osteoarthritis
pt-br
C05.550.114.606 Osteoartrite de Joelho
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Specific descriptors:
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CID 10 - M17 Gonarthrosis; knee arthrosis
pt-br
CID 10 - M17 Gonartrose; artrose do joelho
Interventions
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Interventions:
en
A therapeutic intervention program will be carried out for elderly women with and without knee osteoarthritis (arthrosis). For this, 25 elderly women with knee arthrosis (grades 2 or 3) (GOA, n=25) and 25 control elderly women without the disease will be recruited. The intervention will be a physiotherapy exercise program for lower limb muscle strength training, reactive and proactive balance and gait training with visual feedback from foot support in different directions. The groups of elderly women with and without knee arthrosis will receive the intervention program for two consecutive months, twice a week, with a duration of 45 minutes each session.
pt-br
Será realizado um programa de intervenção terapêutica para idosas com e sem osteoatrite de joelho (artrose). Para isso, serão recrutadas 25 idosas com artrose de joelho (graus 2 ou 3) (GOA, n=25) e 25 idosas controle, sem a doença. A intervenção será um programa de exercícios de fisioterapia para treino resistência muscular dos membros inferiores, equilíbrio reativo e proativo e treino de marcha com feedback visual do apoio dos pés em diferentes direções. Os grupos de idosas com e sem artrose de joelho receberão o programa de intervenção durante dois meses consecutivos, por duas vezes na semana, com duração de 45 minutos cada sessão.
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Descriptors:
en
22061 Physiotherapy program for lower limb muscle resistance training, reactive and proactive balance and gait training with visual feedback for foot support in different directions
pt-br
22061 Programa de fisioterapia para treino resistência muscular dos membros inferiores, equilíbrio reativo e proativo e treino de marcha com feedback visual do apoio dos pés em diferentes direções
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 07/01/2021 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 50 F 60 Y 80 Y -
Inclusion criteria:
en
elderly women; ages between 60 and 80 years; grade 2 or 3 knee arthrosis; knee pain with intensity between 3 and 8; body weight index less than 35 kg/m2; walk independently
pt-br
mulheres idosas; idades entre 60 e 80 anos; artrose de joelho com graus 2 ou 3; dor no joelho com intensidade entre 3 e 8; índice de peso corporal menor que 35 kg/m2; andar de forma independente
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Exclusion criteria:
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Lower limb prostheses and/or orthotics; fractures in the last six months; hip and ankle arthrosis; diabetic neuropathies; rheumatoid arthritis; tissue injuries; dementia pictures; physical therapy treatment with exercises during the intervention period.
pt-br
Próteses e/ou órteses em membros inferiores; fraturas nos últimos seis meses; artrose de quadril e tornozelo; neuropatias diabéticas; artrite reumatóide; lesões teciduais; quadros de demência; tratamento fisioterapêutico com exercícios durante período da intervenção.
Study type
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Study design:
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Expanded access program Purpose Intervention assignment Number of arms Masking type Allocation Study phase 1 Treatment Parallel 2 Single-blind Randomized-controlled 1
Outcomes
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Primary outcomes:
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Assess knee functionality; it is expected to find an increase in knee function after the therapeutic intervention protocol in elderly women with knee arthrosis compared to control elderly women. To assess knee functionality, the following questionnaires will be used: WOMAC (Western Ontario and MacMaster Universities Osteoarthritis) and Lequesne's Algo-Functional.
pt-br
Avaliar a funcionalidade do joelho; espera-se encontrar um aumento da função do joelho após o protocolo de intervenção terapêutica das idosas com artrose de joelho comparada as idosas controle. Para avaliar a funcionalidade do joelho serão utilizados os questionários: WOMAC (Western Ontario and MacMaster Universities Osteoarthritis) e o Algo-Funcional de Lequesne.
en
Assess the intensity of knee pain; it is expected to find a reduction in knee pain after the therapeutic intervention protocol in elderly women with knee arthrosis compared to control elderly women. To assess pain, the Visual Analog Scale will be used.
pt-br
Avaliar a intensidade de dor no joelho; espera-se encontrar uma redução da dor no joelho após o protocolo de intervenção terapêutica das idosas com artrose de joelho comparada as idosas controle. Para avaliar a dor será utilizada a Escala Visual Analógica.
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Secondary outcomes:
en
Assess the distribution of plantar pressure during walking and in the still standing posture; it is expected to find a reduction in plantar load during walking and an increase in body sway in the standing posture after the therapeutic intervention protocol of elderly women with knee arthrosis compared to control elderly women. To assess plantar pressure distribution during walking and in the still standing posture, a pressure platform will be used (Loran®, Italy).
pt-br
Avaliar a distribuição da pressão plantar durante o andar e na postura quieta parada; espera-se encontrar uma redução da carga plantar durante o andar e um aumento da oscilação corporal na postura parada após o protocolo de intervenção terapêutica das idosas com artrose de joelho comparada as idosas controle. Para avaliar distribuição da pressão plantar durante o andar e na postura quieta parada será utilizado uma plataforma de pressão (Loran®, Itália).
en
Assess walking during the six-minute intervention; it is expected to find an increase in the walking distance after the therapeutic intervention protocol for elderly women with knee arthrosis compared to control elderly women. To assess walking, the six-minute walk test (6MWT) will be used.
pt-br
Avaliar o andar durante o intervenho de seis minutos; espera-se encontrar um aumento da distância caminhada após o protocolo de intervenção terapêutica das idosas com artrose de joelho comparada as idosas controle. Para avaliar ao andar será utilizado o teste de caminhada de seis minutos (TC6M).
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Assess balance; it is expected to find an increase in balance after the therapeutic intervention protocol for elderly women with knee arthrosis compared to control elderly women. To assess balance, the Timed Get Up and Go Test (TUG) will be used.
pt-br
Avaliar o equilíbrio; espera-se encontrar um aumento do equilíbrio após o protocolo de intervenção terapêutica das idosas com artrose de joelho comparada as idosas controle. Para avaliar ao o equilíbrio será utilizado o teste Timed Get Up and Go Test (TUG).
en
Assess the perception of the risk of falling; it is expected to find an increase in the perception of falling after the therapeutic intervention protocol of elderly women with knee arthrosis compared to control elderly women. To assess the perception of risk of falling, the FRAQ-Brazil (Falls Risk Awareness Questionnaire) questionnaire will be used.
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Avaliar a Percepção do risco de queda; espera-se encontrar um aumento da percepção de queda após o protocolo de intervenção terapêutica das idosas com artrose de joelho comparada as idosas controle. Para avaliar a percepção do risco de queda será utilizado o questionário FRAQ-Brazil (Falls Risk Awareness Questionnaire).
Contacts
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Public contact
- Full name: Tatiane Silva de Souza
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- Address: rua prof. Enéas de Siqueira Neto, 340
- City: São Paulo / Brazil
- Zip code: 04829-300
- Phone: 55 11 95911 7264
- Email: tattianesilva1@gmail.com
- Affiliation:
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Scientific contact
- Full name: Ana Paula Ribeiro
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- Address: rua prof. Enéas de Siqueira Neto, 340
- City: São Paulo / Brazil
- Zip code: 04829-300
- Phone: 55 11 99139-2168
- Email: anapaulafisioterapia@yahoo.com.br
- Affiliation:
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Site contact
- Full name: Tatiane Silva de Souza
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- Address: rua prof. Enéas de Siqueira Neto, 340
- City: São Paulo / Brazil
- Zip code: 04829-300
- Phone: 55 11 95911 7264
- Email: tattianesilva1@gmail.com
- Affiliation:
Additional links:
Total de Ensaios Clínicos 16963.
Existem 8359 ensaios clínicos registrados.
Existem 4701 ensaios clínicos recrutando.
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