Effects of Aerobic Training and Inspiratory Muscle Training in Patients During Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Maximal Inspiratory Pressure Test
研究概览
简要总结
The hospitalization for hematopoietic stem cell transplantation (HSCT) impairs the physical functioning and functional capacity, but aerobic physical training and, more recently, inspiratory muscle training, have shown benefits to patients' health submitted to this intervention. However, is not known the effect of aerobic physical training combined with inspiratory muscle training in hospitalized patients for HSCT. The purpose of the study will be verify the safety, feasibility and effects of the training association.
详细描述
Sample Patients consecutively admitted to Bone Marrow Transplantation Unit - University Hospital of Juiz de Fora - EBSERH will be included. Patients will be monitored from admission to hospital discharge and randomized by drawing on opaque paper for the Combined Physical Training Group (aerobic physical training + inspiratory muscle training) or the Aerobic Physical Training Group.
Interview Volunteers will go through an interview and directed physical examination. All volunteers will respond to Baecke's questionnaire to investigate habitual physical activity levels.
Feasibility and safety assessment of the study The viability of the study will be verified by: 1) recruitment (recruitment of at least 60% of eligible patients); 2) adherence (achievement of at least 70% of the total number of minutes of the scheduled interventions); 3) friction (percentage of patients who started but did not complete the intervention).
Safety will be verified by the number of spontaneous or unexpected reactions and adverse events resulting from the proposed interventions.
Quality of life and fatigue questionnaire To evaluate the quality of life, the European Organization for Research and Treatment of Cancer (EORTC-Quality of Life Questionnaire-C30) will be used.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients consecutively admitted to Bone Marrow Transplantation-HU-UFJF-EBSERH for allogeneic or autologous HSCT
- •Non-smokers
- •Non-alcoholics
- •Sedentary for at least three months prior to hospitalization
- •Absence of orthopedic limitations and / or cognitive alterations that impede the physical training and the understanding of the evaluation instruments
排除标准
- •Patients hospitalized for post-HSCT complications or for other reasons that do not involve HSCT
- •Patients who develop metastases and graft-versus-host disease during hospitalization
结局指标
主要结局
Maximal Inspiratory Pressure Test
时间窗: On the admission and hospital discharge, an average of 20 to 30 days
The maximal inspiratory pressure will be measured by digital manovacuometry (cmH20)
次要结局
- Incidence of Aerobic and Inspiratory Muscle Training - Adverse Events (Safety)(During the entire hospitalization, daily, during an average of 20 to 30 days)
- Quality of Life(On the admission and hospital discharge, an average of 20 to 30 days)
- Feasibility of Aerobic and Inspiratory Muscle Training(During the entire hospitalization, daily, during an average of 20 to 30 days)
- Hematological Variables(During the entire hospitalization, daily, during an average of 20 to 30 days)
- Clinical Symptoms(During the entire hospitalization, daily, during an average of 20 to 30 days)
- Fatigue(On the admission and hospital discharge, an average of 20 to 30 days)
- Muscle Strength of Lower Limbs(On the admission and hospital discharge, an average of 20 to 30 days)
- Functionality(On the admission and hospital discharge, an average of 20 to 30 days)
- Cardiac Autonomic Control(Hospital admission day, the end of chemotherapy day, the beginning and end of neutropenia days and the day of hospital discharge, during an average of 20 to 30 days to study completion.)
- Duration of Neutropenia(During the entire hospitalization, daily, during an average of 20 to 30 days)
- Functional Capacity(On the admission and hospital discharge, an average of 20 to 30 days)
- Blood Pressure(During the entire hospitalization, daily, during an average of 20 to 30 days)
- Duration of Hospitalization(During the entire hospitalization, daily, during an average of 20 to 30 days)
- Muscle Strength of Upper Limbs(On the admission and hospital discharge, an average of 20 to 30 days)
- Heart Rate(During the entire hospitalization, daily, during an average of 20 to 30 days)
研究者
Daniel Godoy Martinez
PhD
Federal University of Juiz de Fora