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- Ensaio Clínico NCT04724356
Effect of Exercise Mode in Breast Cancer-Related Lymphedema (Lymphedema)
8 de setembro de 2021 atualizado por: Maged Basha, Qassim University
Effect of Exercise Mode on Physical Function and Quality of Life in Breast Cancer-Related Lymphedema: A Randomized Controlled Trial
Gaining a greater understanding of how each exercise mode affects lymphedema, as well as other health-related outcomes will improve exercise prescription guidelines relevant to this specific lymphedema.
Therefore, the purpose of this work was to compare the effects of Xbox kinect rehabilitation and resistance exercises on limb volume, symptoms severity, physical function, and quality of life in women with Breast cancer-related lymphedema.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Breast cancer-related lymphedema is a common and debilitating side effect of cancer treatment.
This study compared the effect of Xbox kinect rehabilitation and resistance exercises on breast cancer-related lymphedema volume and severity, as well as participant's physical function and quality of life.
Women diagnosed with unilateral breast cancer related lymphedema were randomly divided into two groups: the kinect based rehabilitation group KBRG and resistance exercise group REG.
woman in The KBRG received virtual reality therapy using Xbox Kinect-based games, the REG received resistance training in addition both groups received complex decongestive physiotherapy.
The intervention was five sessions per week for 8 weeks.
The outcome measures included limb volume, symptoms severity, physical function (muscle strength and range of motion) and quality of life.
All these outcomes were assessed at pretreatment (baseline) and after the end of treatment at week eight (W8).
Tipo de estudo
Intervencional
Inscrição (Real)
52
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
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Cairo, Egito, 11241
- Shorook Physical Therapy Centers
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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
30 anos a 65 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Age more than 30.
- Histological diagnosis of breast cancer at least 1 year prior to the study.
- Clinical diagnosis of unilateral Breast cancer-related lymphedema and obtained medical clearance from their medical oncologists or surgeons.
- Clinical diagnosis of lymphedema was defined as having at least a 5 % inter-limb discrepancy in volume or circumference.
Exclusion Criteria:
- Unstable lymphedema, receiving intensive therapy within the previous 3 months.
- A musculoskeletal, cardiovascular and/or neurological disorder that could inhibit them from exercising.
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 |
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Experimental: Virtual Reality Group
The Kinect based rehabilitation group received virtual reality therapy using Xbox Kinect-based games, in addition to complex decongestive physiotherapy.
The intervention was led once per day, five days a week, over 8 weeks.
All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.
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Intervention was led once per day, five days a week, over 8 weeks.
Outros nomes:
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Experimental: Resistance exercise Group
The resistance exercise group received resistance training, in addition to complex decongestive physiotherapy.
The intervention was led once per day, five days a week, over 8 weeks.
All participants wearing multilayer bandage or compression stocking during training to avoid exacerbation of the lymphedema in the affected limb.
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Intervention was led once per day, five days a week, over 8 weeks.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Limb volume measurement
Prazo: at baseline
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assessed by circumference measurements using a non-elastic tape.
Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
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at baseline
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Limb volume measurement
Prazo: after 8 weeks
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assessed by circumference measurements using a non-elastic tape.
Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
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after 8 weeks
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Limb volume measurement
Prazo: after 12 weeks
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assessed by circumference measurements using a non-elastic tape.
Measures started just distal to the metacarpal-phalangeal joints and were taken at 4-cm intervals up the arm until the base of the axilla.
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after 12 weeks
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Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Prazo: at baseline
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assessed using the Medical Outcomes Study short-form (SF-36).
Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
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at baseline
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Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Prazo: after 8 weeks
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assessed using the Medical Outcomes Study short-form (SF-36).
Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
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after 8 weeks
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Health-related quality of life, Medical Outcomes Study short-form (SF-36)
Prazo: after 12 weeks
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assessed using the Medical Outcomes Study short-form (SF-36).
Outcomes of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health domains were reported as norm-based scores.
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after 12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Shoulder range of motion
Prazo: at baseline
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Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position.
External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
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at baseline
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Shoulder range of motion
Prazo: after 8 weeks
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Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position.
External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
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after 8 weeks
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Shoulder range of motion
Prazo: after 12 weeks
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Active flexion and abduction of the shoulder were assessed with the elbow extended in the supine position.
External rotation was measured while the shoulder was adducted and in neutral position with the forearm in neutral supination and pronation while sitting on a chair.
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after 12 weeks
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Visual analogue scale
Prazo: at baseline
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used to quantify the severity of perceived pain, heaviness, and tightness.
Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
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at baseline
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Visual analogue scale
Prazo: after 8 weeks
|
used to quantify the severity of perceived pain, heaviness, and tightness.
Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
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after 8 weeks
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Visual analogue scale
Prazo: after 12 weeks
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used to quantify the severity of perceived pain, heaviness, and tightness.
Participants rated their symptom severity from no pain/no discomfort (score = 0) to very severe pain/worst imaginable discomfort (score = 10)
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after 12 weeks
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Muscle strength
Prazo: at baseline
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The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
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at baseline
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Muscle strength
Prazo: after 8 weeks
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The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
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after 8 weeks
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Muscle strength
Prazo: after 12 weeks
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The affected upper extremity flexion, abduction, and external rotation muscle strength were measured during maximal voluntary isometric muscle contraction with the J Tech Commender Muscle Tester (Salt Lake City, Utah, USA) handheld dynamometer according to reported positions.
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after 12 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Maged Basha, PhD, College of medical rehabilitation, Qassim University
- Diretor de estudo: Fatma Alzahraa Kamel, PhD, Cairo University
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Vicini F, Shah C, Arthur D. The Increasing Role of Lymphedema Screening, Diagnosis and Management as Part of Evidence-Based Guidelines for Breast Cancer Care. Breast J. 2016 May;22(3):358-9. doi: 10.1111/tbj.12586. Epub 2016 Feb 29. No abstract available.
- Morgan PA, Franks PJ, Moffatt CJ. Health-related quality of life with lymphoedema: a review of the literature. Int Wound J. 2005 Mar;2(1):47-62. doi: 10.1111/j.1742-4801.2005.00066.x.
- Aguilar-Lazcano CA, Rechy-Ramirez EJ, Hu H, Rios-Figueroa HV, Marin-Hernandez A. Interaction Modalities Used on Serious Games for Upper Limb Rehabilitation: A Systematic Review. Games Health J. 2019 Oct;8(5):313-325. doi: 10.1089/g4h.2018.0129. Epub 2019 Jul 9.
- Basha MA, Aboelnour NH, Alsharidah AS, Kamel FH. Effect of exercise mode on physical function and quality of life in breast cancer-related lymphedema: a randomized trial. Support Care Cancer. 2022 Mar;30(3):2101-2110. doi: 10.1007/s00520-021-06559-1. Epub 2021 Oct 20.
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)
15 de janeiro de 2019
Conclusão Primária (Real)
20 de abril de 2020
Conclusão do estudo (Real)
5 de maio de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
21 de janeiro de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de janeiro de 2021
Primeira postagem (Real)
26 de janeiro de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de setembro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de setembro de 2021
Última verificação
1 de setembro de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2449PT
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
The data sets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Prazo de Compartilhamento de IPD
6 months after publication
Critérios de acesso de compartilhamento IPD
relevance to the topic of the study and approval of all co-authors within 1 month of receiving the request.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
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 .
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