Clinical trial NCT06134297: Adherence, Viability, Clinical Evolution and Therapeutic Efficacy in Patients Undergoing Bone Marrow Transplantation
Official title: Adherence, Feasibility, Clinical Evolution Therapeutic Efficacy of Three Different Muscle Overload Models Used for Physical Rehabilitation of Patients Undergoing Bone Marrow Transplantation: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stem Cell Transplantation
Keywords: Exercise Therapy
Fatigue
Hematologic Neoplasms
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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;

Primary outcomes:
measure: Effectiveness of the physical rehabilitation program for lower limb strength through sitting and standing exercises
timeFrame: During the period of hospital stay, an average 1 month.
measure: Effectiveness of the physical rehabilitation program for upper limb strength using dynamometry
timeFrame: During the period of hospital stay, an average 1 month
measure: Adherence to physical rehabilitation sessions
timeFrame: During the period of hospital stay, an average 1 month
measure: Operational viability for implementing the exercise protocol
timeFrame: During the period of hospital stay, an average 1 month
measure: Satisfaction with physiotherapy care
timeFrame: During the period of hospital stay, an average 1 month
measure: Clinical behavioral evolution of signs and symptoms related to cancer
timeFrame: During the period of hospital stay, an average 1 month
measure: Clinical behavioral evolution of signs of fatigue
timeFrame: During the period of hospital stay, an average 1 month
measure: Clinical behavioral evolution of signs of anxiety and depression
timeFrame: During the period of hospital stay, an average 1 month
measure: Clinical behavioral evolution of quality of life perception
timeFrame: During the period of hospital stay, an average 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Santa Casa de Misericórdia de Porto Alegre
state: RS
Study officials:
affiliation: Federal University of Health Science of Porto Alegre
name: Fabricio E Macagnan
role: PRINCIPAL_INVESTIGATOR
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