Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation
NCT ID: NCT06134297
Last Updated: 2023-11-18
Study Results
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Basic Information
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ENROLLING_BY_INVITATION
NA
93 participants
INTERVENTIONAL
2022-03-07
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Aerobic Exercise Group
Aerobic exercise using a cycle ergometer lasting 15 consecutive minutes with load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age).
Cycle ergometer
The Aerobic Exercise Group will perform a cycle ergometer for 15 consecutive minutes with a load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). Peripheral oxygen saturation will be controlled and, upon a sustained drop (\> 2 minutes after load reduction) below 90%, the session will be interrupted. The subjective feeling of tiredness in the legs and shortness of breath will be constantly monitored and if values equal to or greater than 8 (0-10) occur, the exercise will be stopped.
Anaerobic Exercise Group
Muscle strength training using shin guards and elastic bands to promote muscle overload, generating maximum force production, where the contraction time should not exceed 20 seconds.
Strength Training - elastic band and shin guards
The Anaerobic Exercise Group will perform muscular strength training using maximum strength, where the contraction time should not exceed 20 seconds. For the upper limbs, the overload used will be through the use of an elastic band, with guidance for the patient to perform the shoulder external rotation exercise, elbow flexion exercises and open row rowing exercise. For the lower limbs, bridge movements, lunges and sit-up exercises will be performed with a maximum of 15 repetitions, and overload with ankle weights or dumbbells can be used in addition to body weight. The muscle contraction should lead the patient to a state of muscular fatigue and if the objective is not achieved, the exercise will be adapted to require greater strength from the patient so that he or she can reach maximum strength.
Mixed Exercise Group
Exercises through alternation between aerobic and anaerobic overload (performing the exercises from the previously mentioned groups on alternate days), in a 1:1 ratio until the end of the physical rehabilitation program.
Cycle ergometer, elastic band and shin guards
Mixed Exercise Group will perform the exercises by alternating between aerobic and anaerobic overload, in a 1:1 ratio until the end of the physical rehabilitation program, following exactly the same protocols described previously (alternating one session of the aerobic protocol and in the following session the anaerobic protocol).
Interventions
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Cycle ergometer
The Aerobic Exercise Group will perform a cycle ergometer for 15 consecutive minutes with a load adjusted to maintain heart rate (HR) between 65-75% of the maximum HR predicted for age (HRmax = 200-age). Peripheral oxygen saturation will be controlled and, upon a sustained drop (\> 2 minutes after load reduction) below 90%, the session will be interrupted. The subjective feeling of tiredness in the legs and shortness of breath will be constantly monitored and if values equal to or greater than 8 (0-10) occur, the exercise will be stopped.
Strength Training - elastic band and shin guards
The Anaerobic Exercise Group will perform muscular strength training using maximum strength, where the contraction time should not exceed 20 seconds. For the upper limbs, the overload used will be through the use of an elastic band, with guidance for the patient to perform the shoulder external rotation exercise, elbow flexion exercises and open row rowing exercise. For the lower limbs, bridge movements, lunges and sit-up exercises will be performed with a maximum of 15 repetitions, and overload with ankle weights or dumbbells can be used in addition to body weight. The muscle contraction should lead the patient to a state of muscular fatigue and if the objective is not achieved, the exercise will be adapted to require greater strength from the patient so that he or she can reach maximum strength.
Cycle ergometer, elastic band and shin guards
Mixed Exercise Group will perform the exercises by alternating between aerobic and anaerobic overload, in a 1:1 ratio until the end of the physical rehabilitation program, following exactly the same protocols described previously (alternating one session of the aerobic protocol and in the following session the anaerobic protocol).
Eligibility Criteria
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Inclusion Criteria
* Present hematological malignancy undergoing first antineoplastic treatment with HSCT;
* Have intact neurological function and cognition;
* Be in clinical conditions that allow participation in physical rehabilitation;
* To agree with the study proposal by signing the Free and Informed Consent Form (TCLE).
Exclusion Criteria
* Present previous musculoskeletal changes that interfere with the execution of physical performance assessment tests;
* Patients with limiting cardiovascular or pulmonary disease, significant psychiatric or neurological disorders and/or limiting interpretation of documents and forms that will be used in the study;
* Patients who require mobility assistance and/or diagnosed with multiple myeloma with or without the presence of bone metastasis;
18 Years
64 Years
ALL
No
Sponsors
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Federal University of Health Science of Porto Alegre
OTHER
Responsible Party
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Fabrício Edler Macagnan
Principal Investigator
Principal Investigators
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Fabricio E Macagnan
Role: PRINCIPAL_INVESTIGATOR
Federal University of Health Science of Porto Alegre
Locations
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Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Countries
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References
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Other Identifiers
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54240221.5.0000.5335
Identifier Type: -
Identifier Source: org_study_id
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