Teste Piloto de Reabilitação do Núcleo Abdominal para Melhorar os Resultados Após Correção de Hérnia Ventral (ABVENTURE-P)
7 de maio de 2026 atualizado por: Ajit Chaudhari, Ohio State University
Este estudo tem como objetivo avaliar o papel potencial da fisioterapia na melhora dos resultados após o reparo da hérnia ventral.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Depois de serem informados sobre o estudo e os riscos potenciais, todos os pacientes que fornecerem consentimento informado por escrito realizarão avaliações de várias atividades da vida diária e preencherão várias pesquisas detalhando suas habilidades pré-cirúrgicas, qualidade de vida e dor.
Imediatamente após o procedimento cirúrgico, os pacientes serão randomizados de forma simples-cega (investigador) em uma proporção de 1:1 para fisioterapia supervisionada (8 semanas, duas vezes por semana) ou precauções pós-cirúrgicas padrão.
Avaliações e pesquisas serão repetidas pelo investigador cego em 30 dias, 10 semanas, 6 meses e 1 ano após a cirurgia.
Tipo de estudo
Intervencional
Inscrição (Real)
138
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Ohio
-
Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Wexner Medical Center
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão
- Maiores de 18 anos
- Diagnóstico de hérnia ventral
- Agendado para correção eletiva de hérnia ventral
- Estado funcional independente
- Largura da hérnia transversal de 2 cm ou mais
Critério de exclusão
- Distúrbio de movimento ou equilíbrio previamente diagnosticado
- Uso de dispositivo auxiliar ambulatorial (andador ou bengala)
- Não está atualmente passando ou planejando se submeter a fisioterapia ou outra intervenção de exercício especializado supervisionada por um profissional de reabilitação médica
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Instruções pós-operatórias padrão
Os participantes do grupo de controle serão informados na alta pós-operatória de que devem seguir as instruções pós-operatórias.
|
Esta intervenção inclui instruções padrão de cuidados pós-operatórios normalmente dadas a pacientes submetidos a correção de hérnia ventral em todo o mundo.
Isso inclui limitar a atividade física extenuante e uma restrição de levantamento de peso não superior a 10 libras por 6 semanas.
O uso de fichário também é incentivado por 4-6 semanas após a operação.
|
|
Experimental: Fisioterapia Supervisionada
Os participantes do grupo de fisioterapia serão agendados para visitas à clínica de fisioterapia começando duas semanas após a cirurgia e serão submetidos a tratamentos de fisioterapia supervisionados aproximadamente duas vezes por semana durante oito semanas de acordo com uma reabilitação pós-operatória de cirurgia abdominal central padronizada baseada em evidências programa.
|
O curso de fisioterapia supervisionada de 8 semanas duas vezes por semana começa 2 semanas após a cirurgia.
Ele tem como alvo a função do núcleo abdominal por meio do retreinamento e fortalecimento muscular progressivo, postura específica do paciente e educação da mecânica corporal.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change From Baseline in Five Times Sit-to-stand Time
Prazo: Baseline before surgery, 10 weeks after surgery
|
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
The test is scored in seconds, where a shorter time represents greater mobility.
|
Baseline before surgery, 10 weeks after surgery
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Prazo: Baseline before surgery, 10 weeks after surgery
|
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function.
The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual.
Higher scores indicate greater physical function.
This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
|
Baseline before surgery, 10 weeks after surgery
|
|
Change From Baseline in Quiet Unstable Sitting Test
Prazo: Baseline before surgery, 10 weeks after surgery
|
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds.
QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population.
A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population.
A positive change indicates improvement in core stability, with an MCID for change ≥1.
The total range of the measure can be as high as 0 and has no explicit negative bound.
|
Baseline before surgery, 10 weeks after surgery
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Hernia Related Quality of Life Survey From Baseline
Prazo: baseline before surgery, 10 weeks after surgery
|
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health.
The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
|
baseline before surgery, 10 weeks after surgery
|
|
Change in Timed Up-And-Go Time From Baseline
Prazo: baseline before surgery, 10 weeks after surgery
|
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down.
Do all of these as quickly as can be done safely.
The test is scored in seconds, and a lower time indicates better mobility.
|
baseline before surgery, 10 weeks after surgery
|
|
Change From Baseline in International Physical Activity Questionnaire - Short Form
Prazo: baseline before surgery, 10 weeks after surgery
|
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
The test is scored in Metabolic Equivalent of Task (MET)-minutes per week.
More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
|
baseline before surgery, 10 weeks after surgery
|
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Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Prazo: baseline before surgery, 10 weeks after surgery
|
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities.
Scores range from 11 (lowest) to 44 (highest).
Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
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baseline before surgery, 10 weeks after surgery
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Number of Participants With Hernia Recurrence Using the Hernia Recurrence Inventory
Prazo: 1 year after surgery
|
Patient-reported questionnaire asking questions regarding a recurrence of the hernia based on pain and presence of a physical bulge.
A recurrence is determined by if the patient reports thinking the hernia has come back, feeling or seeing a bulge, or having pain or symptoms at the site.
A positive response to any of these 3 questions is considered a recurrence.
A recurrence is considered a suboptimal outcome.
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1 year after surgery
|
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Change in Hernia Related Quality of Life Survey From Baseline
Prazo: baseline before surgery, 1 year after surgery
|
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health.
The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
|
baseline before surgery, 1 year after surgery
|
|
Change in Timed Up-And-Go Time From Baseline
Prazo: baseline before surgery, 1 year after surgery
|
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down.
Do all of these as quickly as can be done safely.
The test is scored in seconds, and a lower time indicates better mobility.
|
baseline before surgery, 1 year after surgery
|
|
Change From Baseline in International Physical Activity Questionnaire - Long Form
Prazo: baseline before surgery, 1 year after surgery
|
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
The test is scored in Metabolic Equivalent of Task (MET)-minutes per week.
More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
|
baseline before surgery, 1 year after surgery
|
|
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Prazo: baseline before surgery, 1 year after surgery
|
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities.
Scores range from 11 (lowest) to 44 (highest).
Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
|
baseline before surgery, 1 year after surgery
|
|
Change From Baseline in Five Times Sit-to-stand Time
Prazo: baseline before surgery, 1 year after surgery
|
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
The test is scored in seconds, where a shorter time represents greater mobility.
|
baseline before surgery, 1 year after surgery
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Prazo: baseline before surgery, 1 year after surgery
|
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function.
The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual.
Higher scores indicate greater physical function.
This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
|
baseline before surgery, 1 year after surgery
|
|
Change From Baseline in Quiet Unstable Sitting Test
Prazo: baseline before surgery, 1 year after surgery
|
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds.
QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population.
A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population.
A positive change indicates improvement in core stability, with an MCID for change ≥1.
The total range of the measure can be as high as 0 and has no explicit negative bound.
|
baseline before surgery, 1 year after surgery
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Hernia Related Quality of Life Survey From Baseline
Prazo: baseline before surgery, 30 days after surgery
|
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health.
The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
|
baseline before surgery, 30 days after surgery
|
|
Change in Timed Up-And-Go Time From Baseline
Prazo: baseline before surgery, 30 days after surgery
|
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down.
Do all of these as quickly as can be done safely.
The test is scored in seconds, and a lower time indicates better mobility.
|
baseline before surgery, 30 days after surgery
|
|
Change From Baseline in International Physical Activity Questionnaire - Short Form
Prazo: baseline before surgery, 30 days after surgery
|
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
The test is scored in Metabolic Equivalent of Task (MET)-minutes per week.
More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
|
baseline before surgery, 30 days after surgery
|
|
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Prazo: baseline before surgery, 30 days after surgery
|
Self-reported 11-question survey on how fear affects desire and ability to perform physical activities.
Scores range from 11 (lowest) to 44 (highest).
Higher scores indicate greater fear, where 11-22 is minimal fear, 23-28 is low fear, 29-35 is moderate fear, and 36-44 is high fear.
|
baseline before surgery, 30 days after surgery
|
|
Change From Baseline in Five Times Sit-to-stand Time
Prazo: baseline before surgery, 30 days after surgery
|
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
The test is scored in seconds, where a shorter time represents greater mobility.
|
baseline before surgery, 30 days after surgery
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Prazo: baseline before surgery, 30 days after surgery
|
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function.
The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual.
Higher scores indicate greater physical function.
This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
|
baseline before surgery, 30 days after surgery
|
|
Change From Baseline in Quiet Unstable Sitting Test
Prazo: baseline before surgery, 30 days after surgery
|
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds.
QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population.
A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population.
A positive change indicates improvement in core stability, with an MCID for change ≥1.
The total range of the measure can be as high as 0 and has no explicit negative bound.
|
baseline before surgery, 30 days after surgery
|
|
Change in Hernia Related Quality of Life Survey From Baseline
Prazo: baseline before surgery, 6 months after surgery
|
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health.
The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
|
baseline before surgery, 6 months after surgery
|
|
Change in Timed Up-And-Go Time From Baseline
Prazo: baseline before surgery, 6 months after surgery
|
Starting seated in a standard chair, stand, walk forward 3 m, turn 180 deg, walk back to chair, sit down.
Do all of these as quickly as can be done safely.
The test is scored in seconds, and a lower time indicates better mobility.
|
baseline before surgery, 6 months after surgery
|
|
Change From Baseline in International Physical Activity Questionnaire - Long Form
Prazo: baseline before surgery, 6 months after surgery
|
Self-reported physical activity questions spanning sedentary behavior, job activity, transportation activity, household activity, and recreational activity.
The test is scored in Metabolic Equivalent of Task (MET)-minutes per week.
More minutes means greater physical activity, either by increasing time or the intensity of the activity or both.
|
baseline before surgery, 6 months after surgery
|
|
Change From Baseline in Tampa Scale of Kinesiophobia - Short Form
Prazo: baseline before surgery, 6 months after surgery
|
The Hernia-related Quality of Life Survey (HerQLeS) patient-reported questionnaire asks questions about how abdominal wall function affects activities of daily living, independent mobility, and mental health.
The survey is scored on a 0-100 scale, where 100 indicates the highest quality of life and 0 indicates the worst.
|
baseline before surgery, 6 months after surgery
|
|
Change From Baseline in Five Times Sit-to-stand Time
Prazo: baseline before surgery, 6 months after surgery
|
From a standard chair, stand and sit back down five times in immediate succession as quickly as possible.
The test is scored in seconds, where a shorter time represents greater mobility.
|
baseline before surgery, 6 months after surgery
|
|
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function
Prazo: baseline before surgery, 6 months after surgery
|
PROMIS-Physical Function is a computer-adaptive patient-reported questionnaire asking questions about physical function.
The responses are converted to a t-score which is then reported as a percentile, where 50th percentile represents the average individual.
Higher scores indicate greater physical function.
This outcome is reported as a change in percentile, where a change of 0 indicates no change in physical function between the two timepoints and a positive change in percentile points indicates an improvement in physical function relative to the rest of the population.
|
baseline before surgery, 6 months after surgery
|
|
Change From Baseline in Quiet Unstable Sitting Test
Prazo: baseline before surgery, 6 months after surgery
|
Sit on an inflated cushion that creates an unstable surface for 60 seconds with eyes closed and arms crossed while counting to a metronome.
The raw measurement is the center of pressure excursion (cumulative amount of postural sway) of the participant during the 60 seconds.
QUeST is scored as a scaled Z-score, where 0 represents the mean value for a healthy control population.
A negative score indicates how many multiples of the standard error of measurement the participant is worse than the mean value for a healthy normal population.
A positive change indicates improvement in core stability, with an MCID for change ≥1.
The total range of the measure can be as high as 0 and has no explicit negative bound.
|
baseline before surgery, 6 months after surgery
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de abril de 2022
Conclusão Primária (Real)
18 de fevereiro de 2025
Conclusão do estudo (Real)
23 de dezembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
3 de novembro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
19 de novembro de 2021
Primeira postagem (Real)
2 de dezembro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
3 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2021H0336
- R01DK131207 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Somente dados não identificados serão compartilhados com outros pesquisadores.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .