Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation
- Conditions
- FatigueHematopoietic Stem Cell TransplantationLymphomaLeukemiaMultiple Myeloma
- Interventions
- Other: Aerobic training with cycle ergometer
- Registration Number
- NCT04496011
- Lead Sponsor
- Federal University of Health Science of Porto Alegre
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Experimental Group Aerobic training with cycle ergometer In this group the exercise program will be based on the protocol of Control Group, without the exception of walking training, adding aerobic capacity training using the bicycle ergometer, model CBL11 Classic® from ACT®.
- Primary Outcome Measures
Name Time Method Lower Limb Physical Functioning and Strength 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
- Secondary Outcome Measures
Name Time Method Fatigue Trough study completion, an average of 2 months Piper Fatigue Scale, developed by Piper et al. (1998), is a multidimensional measure of fatigue in the field of cancer research and includes subdomains of the behavioral, affective, sensorial and cognitive attributes / fatigue mood, composed of 22 items. The scores for each item range from 0 to 10 and can total 220 points. Higher values characterize a greater perception of fatigue. It will be applied on patient's evaluation day and on hospital discharge day.
Symptoms Assessment Trough study completion, an average of 2 months The Edmonton Symptom Assessment Scalemorning will be applied to eavaluate symptoms of pain, tiredness, drowsiness, appetite, nausea, shortness of breath, depression, anxiety and well-being. It is a scale where the patient provides an auto-report on a score that can vary from 0 to 10, being score 0 absence of symptoms and 10 represents the most intense sensation experienced by the patient.
Timed up and Go (TUG) Trough study completion, an average of 2 months TUG is used in clinical practice to assess mobility, the risk of falls and also to assist in the diagnosis of sarcopenia. For this reason, that test will be compiled or set of tests that will be used to determine physical performance.
Trial Locations
- Locations (1)
Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA
🇧🇷Porto Alegre, RS, Brazil