"Effects of a Resistance Physical Exercise Program in Multiple Myeloma Patients: A Randomized Controlled Trial Study Protocol".
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Health related quality of life
研究概览
简要总结
The goal of this clinical trial is to learn if physical exercise improves quality of life, frailty and mental health in patients with multiple myeloma. It will also learn about the safety and adherence of the program. The main questions it aims to answer are:
Does physical exercise improves quality of life in patients with multiple myeloma? Does physical exercise improves frailty and mental health in patients with multiple myeloma? Researchers will compare supervised physical exercise and home-based unsupervised physical exercise.
Participants will:
Participate in one of the exercise programs, supervised or home-based, for 12 weeks. They will be completely evaluated before and after the intervention.
详细描述
Participants will be patients diagnosed with multiple myeloma (MM) who are undergoing active treatment and who will be recruited from the Haematology Department of Salamanca University Hospital.
Intervention The physical exercise programme has been specifically designed for people diagnosed with MM undergoing active treatment. To ensure methodological quality and reproducibility of the intervention, the recommendations of the Consensus on Exercise Reporting Template (CERT) [X] will be followed, a detailed description of which is included in the supplementary material (Table S2).
The programme will focus primarily on resistance training, supplemented by daily aerobic activities, and will last for a total of twelve weeks. The sample will be randomly assigned to two groups: an intervention group (IG) and a control group (CG), as described below.
- Intervention group The IG will participate in a supervised resistance training programme, with two sessions per week, 12 weeks, supplemented by a home-based physical activity promotion programme to be carried out four times per week. All supervised sessions will be led by a physiotherapist at a health centre.
- Control group The CG will only perform the home-based physical activity promotion program 4 days/week.
The randomisation process for this clinical trial will be carried out using Microsoft Excel 2020, which will generate a list of random numbers for the allocation of participants. Each participant will be assigned a unique number from this list: those with odd numbers will be assigned to the experimental group, and those with even numbers to the control group. This procedure ensures a random and balanced distribution between the groups, minimising possible biases and increasing the validity of the study results. Randomisation will be carried out by a member of staff from the Haematology Department of the University Hospital of Salamanca who will not be involved in the research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Given the study design, it will not be possible to blind participants or assessors to the intervention. However, in order to preserve the objectivity of the results, the statistical analysis will be performed by an independent statistician who is not involved in the study and is unaware of the allocation of participants to the different groups.
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
- •Confirmed diagnosis of MM undergoing active treatment.
- •No regular physical activity during the previous eight weeks.
- •Functional status (ECOG) 0-
- •Signature of informed consent.
排除标准
- •Presence of medical contraindications for physical exercise, such as severe musculoskeletal disorders, severe cardiovascular disease, bone metastases, or other conditions that the medical team considers inappropriate.
- •Inability to complete the initial assessment tests or difficulty performing basic exercises.
- •Any other circumstance that, in the opinion of the investigators, may interfere with the objectives or conduct of the study.
结局指标
主要结局
Health related quality of life
时间窗: 12 weeks
The primary outcome measure will be health related quality of life. Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ). Specifically, the EORTC QLQ-C30 will be used, which is widely used to assess quality of life in cancer patients \[X\]. This instrument consists of 30 items, 24 of which are grouped into five functional domains: physical, role, emotional, cognitive, and social. It also includes three symptom scales-fatigue, pain, and nausea/vomiting-and an overall health status scale. Six other items assess additional symptoms such as dyspnoea, loss of appetite, insomnia, constipation, diarrhoea, and financial difficulties. Responses are recorded on a four-point scale ('none,' 'a little,' 'quite a bit,' 'a lot'), except for the general health and quality of life scales, which use a seven-point format. On the functional and overall health scales, higher scores indicate better health, while on the
次要结局
- Frailty(12 weeks)
- Anxiety and depression(12 weeks)
- Fatigue(12 weeks)
- Sleep quality(12 weeks)
- Physical activity(12 weeks)
- Body composition(12 weeks)
- Strength(12 weeks)
- Physical performance(12 weeks)
研究者
CARLOS MARTIN SANCHEZ
Director
University of Salamanca