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- Ensaio Clínico NCT03389204
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention
Upper Limb Function After Breast Cancer Surgery: the Role of Post-operative Physical Therapy Intervention- Randomized Control Trial
Surgical treatments can cause late effects influencing activity of daily living, physical activity, and overall health. Late effects include persistent pain reported by 30 - 50% of women that underwent breast operations, restrictions of arm and shoulder movement were reported in 35% of patients, lymphedema in 15 - 25% of women who undergo axillary lymph node dissection and in about 6% of women who undergo sentinel lymph node biopsy. Lymphedema results in physical impairments including compromised function, diminished strength, fatigue, and pain in the affected arm . The axillary web syndrome is a self-limiting and frequently overlooked cause of significant morbidity in the early postoperative period after breast cancer, which is characterized by axillary pain that runs down the medial arm, limited shoulder range of motion (ROM) .
Physiotherapy and exercise in the postoperative period can result in a significant improvement in shoulder ROM in women treated for breast cancer, Additionally, exercises are an effective intervention to improve quality of life, cardiorespiratory fitness, physical functioning and fatigue in breast cancer patients. However, in the postoperative period consideration should be given to the early implementation of exercises because of the potential for seroma and increases in wound drainage volume and duration.
There is limited evidence on the influence of postoperative physiotherapy intervention, and instruction program on upper limb range of motion and return to physical activity divided by the type of surgery and regarding complications.
Visão geral do estudo
Descrição detalhada
Aim The aim of this study is to evaluate the influence of early postoperative physical therapy program on upper-limb function and returning to physical activity in the first 6 months following surgery.
Hypotheses
- Early physical activity performed post-operative will improve ROM and therefore, will help women after breast surgeries to return faster to their routine physical activity and by that promote physical health.
- Early postoperative physical therapy is safe when the program for is tailored to the type of surgery.
Methods
Study design Parallel group prospective randomized controlled clinical trial. Two surgical department's including general surgery department and genecology department in Assuta hospital, Tel Aviv, Israel
Sample All women undergoing breast cancer surgeries in Assuta hospital between 02.01.2018 and till 07.01.2019 will be randomized into two groups: Group A (intervention group) will be instructed first day post-operative to exercise program; Group B (control group) without intervention.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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-
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Tel Aviv, Israel, 69710
- Assuta Medican Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Women
- Age 18-65.
- Diagnosed with breast cancer, undergoing breast surgery,
- Functional independence prior to the operation.
- Ability to communicate in Hebrew.
Exclusion Criteria:
- Cognitive disorders, patients unable to sign the consent form.
- Back and spinal morbidity.
- Fibromyalgia or chronic pain disorders.
- Neurological disorders.
- Renal failure with the need for dialysis.
- Lymphedema prior to surgery.
- History of breast surgery.
- Shoulder surgery or shoulder injuries with limited ROM.
- Ischemic heart disease, heart failure and radical heart insufficiency.
- Radical mastectomy, LD and DEIP reconstruction, exchange breast prosthesis.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador Ativo: Breast surgery and exercise
Patient that underwent breast surgery only without other intervention with exercise of the upper limb and instruction to continue after discharge.
|
EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
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Comparador Ativo: Breast surgery and no exercise
Patient after breast surgery alone are discharged without exercise and instructions.
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EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
|
|
Comparador Ativo: Breast, axilar surgery with exercise
Patients that underwent surgery of the breast and axilar lymph node surgery with exercise of the upper limb and instruction to continue after discharge.
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EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
|
|
Comparador Ativo: Breast, axillar surgery without exercise
The patients that underwent surgery of the breast and axilar nodes samples or dissection are discharged without exercise and instructions.
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EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Shoulder pain
Prazo: 6 mnth
|
The intensity of pain and chronological modification will be monitored
|
6 mnth
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Function of upper limb
Prazo: six month
|
The mobility of the shoulder will be evaluates in all movements
|
six month
|
|
Complications
Prazo: six month
|
Possible complications after surgery will be recorded
|
six month
|
|
Lymph edema
Prazo: 6 mnth
|
Radius of upper limb will be measured
|
6 mnth
|
|
physical activities influence in recovery after breast cancer surgery
Prazo: 6 mnth
|
patient will be agruped by intensity and frequency of PA
|
6 mnth
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: Sergio G Susmallian, MD, Assuta Medical Center
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- AMC2020-17
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- Protocolo de estudo
- Termo de Consentimento Livre e Esclarecido (TCLE)
- Relatório de Estudo Clínico (CSR)
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