Is it Feasible to Conduct a Randomised Controlled Trial of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Number of exercise sessions attended
研究概览
简要总结
The investigators propose to determine whether it is acceptable to patients with a diagnosis of multiple myeloma (a type of blood cancer that can cause bone weakness, pain and fatigue) to be offered and attend an exercise group before receiving an autologous stem cell transplantation (being given back one's own stem cells, following receipt of intensive chemotherapy, to enable bone marrow to start producing blood cells again). Exercise has been shown to be effective in reducing many of the side effects of myeloma and the treatment patients receive to manage the disease. Prehabilitation i.e. providing an intervention after diagnosis but before treatment begins has been effective in reducing the severity of side effects of treatment in cancer patients receiving surgery. No evidence exists for its use in patients with myeloma. Patients awaiting transplantation will be provided with information regarding the study and invited to join. Patients who agree to take part will attend the hospital for an assessment of their exercise capability and to complete one set of four questionnaires. They will receive an exercise booklet, advice and complete one attempt at their exercise programme under supervision of a physiotherapist. Patients will be requested to attend the gym for a minimum of six further weeks to complete their exercise programme. Patients will complete a repeat set of questionnaires and a repeat walking test six weeks after the first, on admission to hospital for their transplant and on the day they leave hospital. Some patients will be invited to discuss their opinions of the exercise programme and how useful they felt it was to them in preparing for their transplant. If the study shows that the exercise programme is acceptable to patients and we can recruit enough patients to test it in a larger trial, the investigators will apply for further funding.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will have a diagnosis of multiple myeloma and assigned to the autologous transplantation waiting list for either a first or second transplant
排除标准
- •History of unstable angina or a heart attack in the previous month to allow safe completion of the six minute walk test.
- •Medical stability is a pre-requisite for transplantation so no patients would be excluded on this basis.
研究组 & 干预措施
Intervention
Exercise program
干预措施: Supervised Exercise Program (Other)
结局指标
主要结局
Number of exercise sessions attended
时间窗: 12 months
this is a feasibility study, so monitoring attendance at the study will be the primary outcome measure
次要结局
- Mental well-being(At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment)
- Six minute walking distance(At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment)
- Physical Activity/fitness 1(At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment)
- Physical Activity/fitness 2(At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment)
- Quality of Life 1(At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment)
- Quality of Life 2(At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment)
- Self-efficacy with exercise(At initial assessments and 6th and final exercise session, which will be between 6 and 12 weeks from initial assessment)