Back to resultsEffect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation
Primary Purpose
Fatigue, Leukemia, Lymphoma
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aerobic training with cycle ergometer
Sponsored by
About this trial
This is an interventional treatment trial for Fatigue focused on measuring Autologous transplant, Allogeneic transplant, Physiotherapy, Exercise, Fatigue
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.
Sites / Locations
- Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPARecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental Group
Group Control
Arm Description
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®.
In this group the exercise program is based on the standard physiotherapy protocol that is part of the care routines performed at the bone marrow transplant service. It includes essential components of a rehabilitation program: range of motion, balance training, gait and strength of the upper and lower limbs
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04496011
First Posted
June 7, 2020
Last Updated
July 30, 2020
Sponsor
Federal University of Health Science of Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT04496011
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2020 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fatigue, Leukemia, Lymphoma, Multiple Myeloma, Hematopoietic Stem Cell Transplantation
Keywords
Autologous transplant, Allogeneic transplant, Physiotherapy, Exercise, Fatigue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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®.
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
In this group the exercise program is based on the standard physiotherapy protocol that is part of the care routines performed at the bone marrow transplant service.
It includes essential components of a rehabilitation program: range of motion, balance training, gait and strength of the upper and lower limbs
Intervention Type
Other
Intervention Name(s)
Aerobic training with cycle ergometer
Intervention Description
Patients start with an initial warm-up of 2 minutes, with rotations per minute free, without load. Progressively, the load of the exercise cycle increases every minute up to the supported limit or up to 60% - 70% of maximum heart rate (HRmax). The training will be carried out for 20 continuous minutes, being interrupted whenever the heart rate (HR) reaches 90% of the maximum expected for the age and / or the loss of effort perceived in the BORG scale, above 8 on a scale of 0 to 10.
Primary Outcome Measure Information:
Title
Lower Limb Physical Functioning and Strength
Description
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
Time Frame
Trough study completion, an average of 2 months
Secondary Outcome Measure Information:
Title
Fatigue
Description
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.
Time Frame
Trough study completion, an average of 2 months
Title
Symptoms Assessment
Description
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.
Time Frame
Trough study completion, an average of 2 months
Title
Timed up and Go (TUG)
Description
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.
Time Frame
Trough study completion, an average of 2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabricio Edler Macagnan, PhD
Phone
+55 (51) 3309.8876
Email
fabriciom@ufcspa.edu.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabricio Edler Macagnan, PhD
Organizational Affiliation
Federal University of Health Science of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabricio Edler Macagnan, PhD
Phone
+55 (51) 3309.8876
Email
fabriciom@ufcspa.edu.br
First Name & Middle Initial & Last Name & Degree
Michele Adriane Froelich, Superior
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation
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