Public trial
RBR-26x4bkk Early rehabilitation using a Cycle ergometer after Hip Replacement Surgery: a randomized clinical trial
Date of registration: 05/15/2026 (mm/dd/yyyy)Last approval date : 05/15/2026 (mm/dd/yyyy)
Study type:
Interventional
Scientific title:
en
Rehabilitation with Cycle Ergometer in the postoperative period of hip Arthroplasty during the in-hospital phase: a randomized clinical trial
pt-br
Reabilitação com Cicloergômetro no pós-operatório de Artroplastia de Quadril na fase intra-hospitalar: um ensaio clínico randomizado
es
Rehabilitation with Cycle Ergometer in the postoperative period of hip Arthroplasty during the in-hospital phase: a randomized clinical trial
Trial identification
- UTN code: U1111-1339-7885
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Public title:
en
Early rehabilitation using a Cycle ergometer after Hip Replacement Surgery: a randomized clinical trial
pt-br
Reabilitação precoce com Cicloergômetro após Cirurgia de Prótese de Quadril: um ensaio clínico randomizado
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Scientific acronym:
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Public acronym:
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Secondaries identifiers:
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7.611.701
Issuing authority: Parecer Comitê de Ética em Pesquisa do Einstein Hospital Israelita
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85555724.1.0000.0071
Issuing authority: Plataforma Brasil
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7.611.701
Sponsors
- Primary sponsor: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Secondary sponsor:
- Institution: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Supporting source:
- Institution: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
- Institution: Hospital Israelita Albert Einstein
Health conditions
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Health conditions:
en
Osteoarthritis, Hip; Exercise
pt-br
Osteoartrite do quadril; Exercício Físico
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General descriptors for health conditions:
en
C05.550 Joint Diseases
pt-br
C05.550 Artropatias
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Specific descriptors:
en
C05.550.114.606.400 Osteoarthritis, Hip
pt-br
C05.550.114.606.400 Osteoartrite do Quadril
en
G11.427.410.698.277 Exercise
pt-br
G11.427.410.698.277 Exercício Físico
Interventions
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Interventions:
en
This is a two-arm, open-label randomized controlled trial. Control group (32 participants): will receive the standard institutional physiotherapy protocol. Intervention group (33 participants): will perform cycle ergometer exercise (MOTOmed Viva2®) in 5-minute sessions, without load, conducted twice daily (total of 10 minutes/day), in addition to the standard institutional physiotherapy protocol
pt-br
Trata-se de um ensaio clínico randomizado controlado de mascaramento aberto em dois braços. Grupo controle (32 participantes): receberá o protocolo fisioterapêutico institucional padrão. Grupo intervenção (33 participantes):realizará cicloergômetro (MOTOmed Viva2®), em sessões de 5 minutos, sem carga, realizadas duas vezes ao dia (total de 10 minutos/dia), associadas ao protocolo fisioterapêutico institucional padrão
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Descriptors:
en
E02.760.169.063.500 Rehabilitation
pt-br
E02.760.169.063.500 Reabilitação
Recruitment
- Study status: Recruiting
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Countries
- Brazil
- Date first enrollment: 07/03/2025 (mm/dd/yyyy)
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Target sample size: Gender: Minimum age: Maximum age: 65 - 18 Y 0 -
Inclusion criteria:
en
Patients aged 18 years or older admitted to the orthopedic inpatient unit; who underwent total hip arthroplasty (unilateral or bilateral); are hemodynamically stable; able to perform the proposed protocol; with or without a caregiver; and who agree to participate by signing the informed consent form
pt-br
Pacientes com idade igual ou superior a 18 anos; internados na unidade de ortopedia; submetidos à artroplastia total de quadril (unilateral ou bilateral); hemodinamicamente estáveis; capazes de realizar o protocolo proposto, com ou sem acompanhante; e que concordem em participar mediante assinatura do Termo de Consentimento Livre e Esclarecido
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Exclusion criteria:
en
Patients who refuse to participate; present postoperative complications; have pain that prevents participation in the protocol; are unable to understand instructions; or have orthopedic or clinical limitations that preclude the execution of the intervention
pt-br
Pacientes que não consentirem em participar; que apresentarem complicações pós-operatórias; dor impeditiva para realização do protocolo; incapacidade de compreender as orientações ou limitações ortopédicas ou clínicas que impeçam a execução 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 Open Randomized-controlled N/A
Outcomes
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Primary outcomes:
en
To assess functionality using the Iowa Level of Assistance Scale (ILOAS), measured daily during hospitalization and at the time of hospital discharge
pt-br
Avaliar a funcionalidade utilizando a escala Iowa Level of Assistance Scale (ILOAS), medida diariamente durante a internação e no momento da alta hospitalar
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Secondary outcomes:
en
To assess quality of life using the EuroQol (EQ-5D) questionnaire, measured preoperatively and at the time of hospital discharge
pt-br
Avaliar a qualidade de vida verificada pelo questionário EuroQol (EQ-5D), mensurada no pré-operatório e no momento da alta hospitalar
en
To assess kinesiophobia using the Tampa Scale (TAMPA), measured preoperatively and at the time of hospital discharge
pt-br
Avaliar a cinesiofobia pela Escala de Tampa (TAMPA), mensurada no pré-operatório e no momento da alta hospitalar
Contacts
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Public contact
- Full name: Angélica Cristiane da Cruz Britto
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- Address: Avenida Albert Einstein, 627|701, Morumbi
- City: São Paulo / Brazil
- Zip code: 05652900
- Phone: +55 (14) 998397053
- Email: angelica.cruz@einstein.br
- Affiliation: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Scientific contact
- Full name: Angélica Cristiane da Cruz Britto
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- Address: Avenida Albert Einstein, 627|701, Morumbi
- City: São Paulo / Brazil
- Zip code: 05652900
- Phone: +55 (14) 998397053
- Email: angelica.cruz@einstein.br
- Affiliation: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
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Site contact
- Full name: Angélica Cristiane da Cruz Britto
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- Address: Avenida Albert Einstein, 627|701, Morumbi
- City: São Paulo / Brazil
- Zip code: 05652900
- Phone: +55 (14) 998397053
- Email: angelica.cruz@einstein.br
- Affiliation: Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Additional links:
Total de Ensaios Clínicos 18202.
Existem 9212 ensaios clínicos registrados.
Existem 5025 ensaios clínicos recrutando.
Existem 113 ensaios clínicos em análise.
Existem 6074 ensaios clínicos em rascunho.