Clinical trial NCT04496011: Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fatigue
Leukemia
Lymphoma
Multiple Myeloma
Hematopoietic Stem Cell Transplantation
Keywords: Autologous transplant
Allogeneic transplant
Physiotherapy
Exercise
Fatigue
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patients will be included by convenience (according to the inclusion and exclusion criteria) in non-probabilistic form. The included individuals will be randomized by (nome do Sofwate) in two lists: one for the control group and other for the experimental group. Once defined that the patient will be part of the experimental group, a bicycle ergometer will be kept in the patient's accommodation during the period of hospitalization due to restrictions imposed by the Infection Control Department. Thus, the equipment will remain in the patient´s room during the hospitalization, while the other patients will be allocated to the control group.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lower Limb Physical Functioning and Strength
timeFrame: Trough study completion, an average of 2 months
Secondary outcomes:
measure: Fatigue
timeFrame: Trough study completion, an average of 2 months
measure: Symptoms Assessment
timeFrame: Trough study completion, an average of 2 months
measure: Timed up and Go (TUG)
timeFrame: Trough study completion, an average of 2 months
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Fabricio Edler Macagnan, PhD
role: PRINCIPAL_INVESTIGATOR
References: