- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02420249
Qigong for Breast Cancer Survivors
Randomised Controlled Trial of Qigong Training Programme to Alleviate Arm Oedema, ¬Reduce Shoulder Impairment, Improve Body Balance and Quality of Life in Community-dwelling Breast Cancer Survivors
Objectives: (1) To investigate the effects of Qigong training on upper limb oedema, circulatory status, shoulder flexibility and muscular strength, body balance, and quality of life (QOL) in community-dwelling breast cancer survivors; and (2) to explore the relationship between the impairment outcomes and QOL outcomes.
Hypothesis: (1) The experimental participants will have less impairment and a better QOL after Qigong training compared with the no-training control group; and (2) the impairment parameters will be related to the QOL indexes in the Qigong participants.
Design and subjects: This will be a prospective, randomised, single-blinded controlled trial. Approximately 60 breast cancer survivors will be randomly assigned to either the Qigong training group (n~30) or control group (n~30).
Intervention: Participants in the Qigong group will receive 18 Forms of Tai Chi Internal Qigong training for 3 months with two supervised 1-hour sessions per week.
Main outcome measures: The primary outcome measures are upper limb circumference, arterial blood flow velocities and resistance index, shoulder joint passive range of motion, muscular strength (peak force) and body balance. The secondary outcome measure is quality of life as measured by the Functional Assessment of Cancer Therapy - Breast scale.
Data analysis: Data will be analysed via repeated-measures analysis of variance followed by post-hoc tests (α = 0.05).
Expected results: The investigators pilot studies produced encouraging results on the efficacy of Qigong exercise in reducing chronic breast cancer-related symptoms in survivors. Therefore, the investigators expect that participants in the Qigong group will have fewer upper limb impairments and a better quality of life after Qigong training. If the results are positive, this Qigong training regime is readily transferrable to clinical practice, and could have positive socioeconomic effects such as reduced healthcare costs.
Visão geral do estudo
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pokfulam, Hong Kong
- Recrutamento
- University of Hong Kong
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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:
The inclusion criteria are
- history of a breast malignancy of any stage
- history of mastectomy or lumpectomy with or without adjuvant chemotherapy or radiotherapy
- having completed conventional cancer treatment and medically stable
- no known neurological deficits resulting from breast cancer treatment or other neurological disorders
- persistent lymphoedema defined as a circumference difference greater than 2 cm at any point between the surgical upper limb and contralateral upper limb13
- female aged 18 or above.
Exclusion Criteria:
The exclusion criteria are
- presence of major psychiatric, neurological, musculoskeletal, cardiovascular, peripheral vascular or kidney disorder
- receiving conventional cancer treatments such as chemotherapy or radiotherapy, medications such as diuretics or traditional Chinese medicine
- recurrent cancer or cancer that has spread to another organ
- participation in regular physical activity
- prior experience of Qigong or Tai Chi
- a smoking habit
- pregnancy during the study period.
Plano de estudo
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: Qigong training group
Participants assigned to the Qigong group will receive Qigong training.
The Qigong training programme will be run for 3 months with two supervised 1-hour sessions per week.
Participants will learn the 18 Forms of Tai Chi Internal Qigong.
The training sessions will be conducted by a qualified Qigong instructor from the Natural Health Qigong Association.
Participants in the control group will receive no Qigong training during the study period.
They will receive an 18 Forms of Tai Chi Internal Qigong training package after the study.
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Participants will learn the 18 Forms of Tai Chi Internal Qigong.
Detailed movement and breathing descriptions of the Qigong training protocol can been found in Mak YK. 18 Forms Tai Chi Qigong [in Chinese].
7th ed.
Hong Kong: Wan Li Book Co.; 2012.
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Sem intervenção: Control group
Participants in the control group will receive no Qigong training.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in upper limb circumference
Prazo: Baseline (0 month) and post-intervention (3 months)
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Circumference of both arms will be measured using a cloth measuring tape.
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Baseline (0 month) and post-intervention (3 months)
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Change in arterial resistance and blood flow velocities
Prazo: Baseline (0 month) and post-intervention (3 months)
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A Doppler ultrasound machine will be used to examine the arterial blood flow velocities.
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Baseline (0 month) and post-intervention (3 months)
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Change in shoulder flexibility
Prazo: Baseline (0 month) and post-intervention (3 months)
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A universal goniometer will be used to measure the passive range of motion (ROM) of bilateral shoulder abduction and horizontal abduction.
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Baseline (0 month) and post-intervention (3 months)
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Change in shoulder muscular strength
Prazo: Baseline (0 month) and post-intervention (3 months)
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The maximum isometric muscular strength of the shoulder flexor, abductor, internal rotator and external rotator muscles will be measured bilaterally using the Lafayette Manual Muscle Test System.
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Baseline (0 month) and post-intervention (3 months)
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Change in body balance
Prazo: Baseline (0 month) and post-intervention (3 months)
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Standing balance of the participants will be measured using timed single leg standing test.
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Baseline (0 month) and post-intervention (3 months)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Change in quality of life
Prazo: Baseline (0 month) and post-intervention (3 months)
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Functional Assessment of Cancer Therapy - Breast scale version 4 will be used.
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Baseline (0 month) and post-intervention (3 months)
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 201410159001
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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