Effect of the Use of a Cycloergometer on the Physical Performance of Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized and Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Lower Limb Physical Functioning and Strength
研究概览
简要总结
Physiological changes caused by hematological diseases associated with high dose chemotherapy have a negative impact on patient's functionality, making them more fragile and vulnerable after hematopoietic cell transplantation. Currently, randomized studies have shown that physical exercise can contribute to improve Quality of Life of these patients. In this randomized controlled trial, we will study the effect of using the bicycle ergometer on the physical performance of patients undergoing transplantation of hematopoietic stem cells (HSCT).
详细描述
The sample consists of 30 patients diagnosed with leukemia, lymphoma and multiple myeloma, undergoing high-dose chemotherapy and hematopoietic stem cells transplantation, who will be randomized into two groups. The results of muscle strength in the lower limbs, general mobility, fatigue and clinical symptoms will be compared between the control group and the experimental group.
The control group will perform an exercise program based on the standard protocol of the physiotherapy service, where exercises are performed to gain strength in muscle groups of the upper and lower limbs, range of motion, balance and functional movements. The experimental group will perform the same exercises as the control group, added to a training program using a bicycle ergometer, with an incremental load (from 60% to 70% of the maximum heart rate) for 20 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-70 years) scheduled to perform the first HSCT;
- •Be with a preserved neurological function and full cognition;
- •Have clinical conditions that allow participation in the motor physiotherapy program;
- •Be agreed with a study proposal and sign the free and informed consent form (ICF).
排除标准
- •Develop clinical complications that contraindicate the performance of motor physiotherapy including the practice of the cycle ergometer;
- •Present a previous musculoskeletal alteration that interferes with the performance of physical performance assessment tests;
- •Recent cardiovascular or pulmonary disease;
- •Psychiatric or neurological disorder;
- •Need for gait assistance or presence of bone metastasis
- •Adherence below 50% of the total motor physiotherapy protocol.
结局指标
主要结局
Lower Limb Physical Functioning and Strength
时间窗: Trough study completion, an average of 2 months
The 30-Second Chair Stand evaluates lower limb strength and, indirectly, the risk of falls, especially in the elderly population (JONES, J., RIKLI, 2002). This way, it will compose the set of tests used to determine the physical performance by measuring the number of stands from an armless chair of standard height (45 cm) performed in 30 seconds. The test will be begin when the participant, seating on a neutral spine position and feet flat on the floor, will be instructed to rise to a full stand and return to the original seated position, as quickly as possible. The participant will be instructed to move at maximal speed until they either feel the need to stop or the 30-second time limit is reached. More than 8 unassisted stands for men and women are considered above average for their age, and those below the range as below average
次要结局
- Timed up and Go (TUG)(Trough study completion, an average of 2 months)
- Fatigue(Trough study completion, an average of 2 months)
- Symptoms Assessment(Trough study completion, an average of 2 months)
研究者
Fabrício Edler Macagnan
Sponsor-Investigator
Federal University of Health Science of Porto Alegre