FatigueNCT04496011
Effect of the Cycloergometer in Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing Aerobic training with cycle ergometer in people with Fatigue and Leukemia, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- What is being tested?
- Aerobic training with cycle ergometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Mar 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal de Ciências da Saúde de Porto Alegre - UFCSPA
Porto Alegre, Rio Grande do Sul, 90050-170
Fabricio Edler Macagnan, PhD, +55 (51) 3309.8876, fabriciom@ufcspa.edu.br
Michele Adriane Froelich, Superior
About this study
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
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).
Read the 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.
- Being tested
- Aerobic training with cycle ergometer
- Keywords
- Autologous transplant, Allogeneic transplant, Physiotherapy, Exercise, Fatigue
- Medical subject headings
- Fatigue, Leukemia, Lymphoma, Multiple Myeloma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic training with cycle ergometerOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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®. Receives: Other: Aerobic training with cycle ergometer |
| Group Control | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Trough study completion, an average of 2 months
Secondary outcomes (3)
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.
Measured: Trough study completion, an average of 2 months
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.
Measured: Trough study completion, an average of 2 months
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.
Measured: Trough study completion, an average of 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start2 Mar 2020
- Primary completion30 Sep 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabrício Edler Macagnan, Federal University of Health Science of Porto Alegre
- Investigators
- Fabricio Edler Macagnan, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04496011
- Sponsor's protocol ID
- TMO 2020
- Status last verified
- Jul 2020
- First submitted
- 7 Jun 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04496011
- Acronym / sponsor ID
- TMO 2020
- Keywords
- Autologous transplant, Allogeneic transplant, Physiotherapy, Exercise, Fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 2 Mar 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Aerobic training with cycle ergometerIn 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®. |
| Group Control | No intervention | –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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic training with cycle ergometerPatients 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. | Other | Experimental Group |
Primary outcome
Lower Limb Physical Functioning and Strength
Time frame: 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
3 secondary outcomes
Fatigue
Time frame: Trough study completion, an average of 2 months
Symptoms Assessment
Time frame: Trough study completion, an average of 2 months
Timed up and Go (TUG)
Time frame: Trough study completion, an average of 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabricio Edler Macagnan, PhD principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training with cycle ergometer in people with Fatigue and Leukemia, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabricio Edler Macagnan, PhD (+55 (51) 3309.8876, fabriciom@ufcspa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lower Limb Physical Functioning and Strength (time frame: Trough study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2020.