Safety and Feasibility of Electrical Muscle Stimulation in Patients Undergoing Autologous and Allogeneic Stem Cell Transplantation or Chemotherapy Requiring Hospitalization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Feasibility of self administered EMS
研究概览
简要总结
Intensive chemotherapy, with or without following autologous or allogeneic stem cell transplantation (HSCT), is often the only curative treatment option for patients with haematological malignancies, leave many survivors physically and psychologically impaired because of side effects, many caused by weeks of immobilisation. Electrical muscle stimulation (EMS) is a proven training tool to improve physical performance in seniors and patients with chronic disease. The investigators therefore intend to evaluate the safety and feasibility of EMS in patients undergoing autologous HSCT, allogeneic HSCT and intensive chemotherapy. To assess feasibility all patients are asked to document training time during hospitalization in an EMS diary.
Furthermore, physical Performance will be measured using the 6-minute-walking distance (6MWD) and Short Physical Performance Battery (SPPB) as well as psychological performance using the Multidimensional Fatigue Inventory (MFI) and EORTC QLQ-C30 at the start of chemotherapy (T1) and when patients are discharged from hospital (T2).
At the time intensive chemotherapy is started and all inclusion and no exclusion criteria are met, patients will receive an EMS device with electrodes and will be instructed on how to use the device. After that, baseline tests using the above mentioned tools will be performed.
EMS will be conducted with a "Myopuls 2000" (Curatec Services GmbH, Moers, Germany) device using 13 cm x 5 cm electrodes. Electrodes are placed subsequently on both thighs and upper arms with instructions to stimulate each limb for at least 15 minutes on at least 5 days per week. Stimulation settings were as follows: 300 µs pulse width, 60 Hz frequency, 5 seconds on, 5 seconds off. The amplitude is initially set to elicit a visible muscle contraction and patients are encouraged to increase the amplitude as much as tolerated. After an initial training session, patients are to use the devices on their own and document their activities in an EMS diary.
Patients are then asked to use EMS throughout their therapy in addition to physical therapy until the day of their discharge when the initially performed tests are repeated.
The investigators hypothesis is, that EMS can be safely applied in patients undergoing intensive chemotherapy regimens and that patients are able to administer EMS by themselfs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 - 80 years of age
- •ECOG mperformance status 0-2
- •patients undergoing chemotherapy regimens and and expected hospitalization time of > 14 days
排除标准
- •patients with pacemakers and defibrillators
- •patients with metallic implants close to stimulation sites
- •skin irritations and injuries at the site of electrode placement
- •pregnancy
- •patient is physically or mentally unable to administer EMS by him/her -self
- •history of ventricular arrhythmias
- •peripheral arterial disease
- •deep vein thrombosis in the past 3 month
- •myocardial infarction or stroke in the past 3 month
研究组 & 干预措施
Electrical muscle stimulation
Electrical muscle stimulation is administered on both thighs and upper arms using a Myopuls 2000D device. Pre-set training time is 30 minutes per day (15 minutes for thighs and 15 minutes for upper arms) for at least 5 days a week.
干预措施: Myopuls 2000D (Device)
结局指标
主要结局
Feasibility of self administered EMS
时间窗: At the time of discharge of every patients, after an average of 30 days
Percentage of patients able to complete at least 2/3 of the pre-set training time
Occurence of adverse events caused by EMS
时间窗: through study completion, an average of 30 days
Possible adverse events: bleeding events (defined according to the WHO Bleeding Scale ), arrhythmias, CK elevation, skin irritation
次要结局
- Physical performance as assessed by the 6 minute walking distance(At the time of discharge of every patients, after an average of 30 days)
- Psychological performance as assessed by the Multidimensional Fatigue Inventory(At the time of discharge of every patients, after an average of 30 days)
- Psychological performance as assessed by the EORTC QoL 30 questionnaire(At the time of discharge of every patients, after an average of 30 days)
- Physical performance as assessed by the Short Physical Performance Battery(At the time of discharge of every patients, after an average of 30 days)