Multiple Myeloma Clinical Trial
Official title:
Effect of the Use of a Cycloergometer on the Physical Performance of Patients Undergoing Hematopoietic Stem Cell Transplantation: A Randomized and Controlled Clinical Trial
NCT number | NCT04496011 |
Other study ID # | TMO 2020 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 2, 2020 |
Est. completion date | December 2020 |
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).
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 2020 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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). Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA | Porto Alegre | RS |
Lead Sponsor | Collaborator |
---|---|
Federal University of Health Science of Porto Alegre |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Lower Limb Physical Functioning and Strength | 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 | Trough study completion, an average of 2 months | |
Secondary | Fatigue | 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. | Trough study completion, an average of 2 months | |
Secondary | Symptoms Assessment | 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. | Trough study completion, an average of 2 months | |
Secondary | Timed up and Go (TUG) | 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. | Trough study completion, an average of 2 months |
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