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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Effectiveness of the physical rehabilitation program for upper limb strength using dynamometry
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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;
结局指标
主要结局
Effectiveness of the physical rehabilitation program for upper limb strength using dynamometry
时间窗: During the period of hospital stay, an average 1 month
It will be determined by evaluating the strength performance of the upper limbs through dynamometry. The value will be given in kilograms of force. And it will be calculated through the average of three measurements.
Effectiveness of the physical rehabilitation program for lower limb strength through sitting and standing exercises
时间窗: During the period of hospital stay, an average 1 month.
It will be determined by evaluating lower limb strength performance in the 30-second sit-to-stand test. The score will be based on the number of repetitions performed during the 30 timed seconds.
Clinical behavioral evolution of signs and symptoms related to cancer
时间窗: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - Edmonton Sympton Assessment System Inventory (scale with 9 items; each can be scored from 0 to 10; the final value of the scale is the sum of each item; the higher the score, the worse the symptoms).
Clinical behavioral evolution of signs of anxiety and depression
时间窗: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - General Hospital Anxiety and Depression Scale (14 questions, scored from 0 to 3; the higher the final score, the worse the symptoms).
Satisfaction with physiotherapy care
时间窗: During the period of hospital stay, an average 1 month
It will be evaluated through a satisfaction questionnaire (contains 11 questions and a maximum score of 55 points; the higher the score, the better the test result and better satisfaction).
Adherence to physical rehabilitation sessions
时间窗: During the period of hospital stay, an average 1 month
It will be evaluated through the ratio between the number of sessions actually carried out by the number of days in which the minimum clinical conditions for practicing physical exercise can be fully characterized during the hospital admission.
Operational viability for implementing the exercise protocol
时间窗: During the period of hospital stay, an average 1 month
It will be evaluated through the time needed to execute the different muscle overload protocols
Clinical behavioral evolution of signs of fatigue
时间窗: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - Multidimensional Fatigue Questionnaire - (20 questions scored from 1 to 5; the higher the final score, the worse the symptoms).
Clinical behavioral evolution of quality of life perception
时间窗: During the period of hospital stay, an average 1 month
The following will be carried out at the beginning and end of the intervention: - Basic Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (30 questions scored from 1 to 4; the higher the final score, the worse the symptoms).
次要结局
未报告次要终点
研究者
Fabrício Edler Macagnan
Principal Investigator
Federal University of Health Science of Porto Alegre