Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation

Trial Title: Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation

NCT ID: NCT06134297

Condition: Stem Cell Transplantation

Conditions: Keywords:
Exercise Therapy
Fatigue
Hematologic Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Enrolling by invitation

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Care Provider, Investigator)

Intervention:

Intervention type: Device
Intervention name: Cycle ergometer
Description: 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.
Arm group label: Aerobic Exercise Group

Intervention type: Device
Intervention name: Strength Training - elastic band and shin guards
Description: 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.
Arm group label: Anaerobic Exercise Group

Intervention type: Device
Intervention name: Cycle ergometer, elastic band and shin guards
Description: 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).
Arm group label: Mixed Exercise Group

Summary: Hematological neoplasms originate from the differentiation and proliferation of abnormal lymphatic or myeloid cells that alter the constitution of elements of the blood, bone marrow and lymph nodes. Treatment includes high-dose chemotherapy alone or associated with hematopoietic stem cell transplantation (HSCT). However, the adverse effects of this treatment affect multiple organs and systems, reducing physical capacity, increasing the feeling of fatigue, anxiety and depression, which together affect quality of life. Patients who exercise before, during or after anti-neoplastic treatment demonstrate significant benefits. But rehabilitating physical capacity involves the challenge of fluctuations in the patient's readiness along with daily clinical variations, which ultimately directly affects the rate of adherence to exercises, impacting the effectiveness of the physical rehabilitation program. There is no specific individualization of muscular overload that takes into account such variability in pathophysiological, functional and psychological situations, but the cardiorespiratory response and muscular strength performance in the face of progressive overload can be measured with sufficient recovery periods to optimize the physiological adaptations promoted by muscular overload. regularly, even in patients undergoing antineoplastic treatment. Objective: To evaluate the adherence rate, operational feasibility, clinical/behavioral evolution and effectiveness of three different muscle overload models (aerobic, anaerobic and mixed) used for the physical rehabilitation of patients hospitalized for antineoplastic hematological treatment with HSCT

Detailed description: This is a randomized clinical trial. Patients will be allocated into groups (1) Aerobic; (2) Anaerobic and (3) Mixed. The manifestation of signs and symptoms will be evaluated using the Edmonton Symptom Assessment System (ESAS) inventory, a sensation of fatigue using the multidimensional fatigue questionnaire (MIF), and quality of life using the European Organization for Research and Treatment of Cancer Core Quality of Life questionnaire. Questionnaire (EORTC QLQ-30) and the incidence and intensity of anxiety and depression symptoms using the General Hospital Anxiety and Depression Scale (HAD), in addition to the strength assessment of the upper limbs (HANDGRIP) and lower limbs (TSL). Participants in the aerobic group will perform exercises for the lower limbs with a cycle ergometer for 15 consecutive minutes and participants in the anaerobic group will perform exercises with an overload of shin weights or dumbbells of 0.5kg/1kg for large muscle groups. Participants in the mixed group will have a mixed muscular overload, performed by alternating between aerobic and anaerobic overload with a 1:1 ratio until the end of the program.

Criteria for eligibility:
Criteria:
Inclusion criteria: - Be between 18 and 64 years old; - 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 clinical complications that impair the performance of motor physiotherapy, including the practice of cycle ergometer and resistance exercises; - 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;

Gender: All

Minimum age: 18 Years

Maximum age: 64 Years

Healthy volunteers: No

Locations:

Facility:
Name: Santa Casa de Misericórdia de Porto Alegre

Address:
City: Porto Alegre
Zip: 90020-090
Country: Brazil

Start date: March 7, 2022

Completion date: December 2024

Lead sponsor:
Agency: Federal University of Health Science of Porto Alegre
Agency class: Other

Source: Federal University of Health Science of Porto Alegre

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06134297