Investigation of Pulmonary Rehabilitation on Exercise Capacity, Physical Activity Level, Respiratory Muscle Strength and Endurance During Transplantation Process in Hematopoietic Stem Cell Transplantation Recipients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Maximal exercise capacity
研究概览
简要总结
Stem cell transplantation is a process in which stem cells are harvested from either a patient's or donor's bone morrow or peripheral blood for intravenous infusion. Hematopoietic stem cell transplantation is a treatment with a high curative potential that may benefit a great number of patients with hematological, oncological, immunologic and hereditary diseases. In contrast, there are significant risks of chronic and acute complications due to conditioning regimens and immunosuppression, toxicity infections, graft versus host disease (GVHD) and inactivity including being bedridden. Patients undergoing hematopoietic stem cell transplantation are exposed to risk factors due to chemotherapy, whole body radiation, high dose corticosteroids, treatment-related inactivity, transplantation and GVHD-related muscle damage. Direct toxicity of the cardiovascular and musculoskeletal system (left ventricular dysfunction, pulmonary fibrosis) in relation to hematopoietic stem cell transplantation and secondary indirect physiological consequences of treatment such as exercise intolerance, sarcopenia are seen.
In literature, there are few studies showing that aerobic exercise and resistance training applied during and after the transplantation process has positive effects on muscle strength and endurance, fatigue, functional performance, quality of life and physical activity. It has been shown in the literature that inspiratory muscle training in allogeneic hematopoietic stem cell transplant recipients increases functional exercise capacity, inspiratory and expiratory muscle strength, and reduces effort dyspnea perception, but the effects of inspiratory muscle training during transplantation have not been investigated. There are no studies showing long-term follow-up of comprehensive cardiopulmonary rehabilitation program during hematopoietic stem cell transplantation and which of these outcome measures are survival effect. Therefore, the investigators aimed to investigate the effect of cardiopulmonary rehabilitation on hematopoietic stem cell transplantation in terms of exercise capacity, respiratory and peripheral muscle strength, respiratory muscle endurance, respiratory function, physical activity level, fatigue, depression and quality of life effects and the effect of these outcome measures on survival.
详细描述
According to sample size calculation 20 patients scheduled for hematopoietic stem cell transplantation will be included. Patients scheduled for hematopoietic stem cell transplantation will be evaluated four times; pre-transplantation, post-transplantation, 100th day after transplantation and 1st year after transplantation. Recipients will be randomized into study and control groups. Cardiopulmonary rehabilitation programme includes inspiratory muscle training, upper extremity aerobic exercise, progressive resistance training will be performed study groups. Upper extremity aerobic exercise and progressive resistance training will be performed control groups. Exercise capacity, physical activity, pulmonary functions, respiratory and peripheral muscle strength, respiratory muscle endurance, dyspnea and fatigue perception, depression and quality of life will be evaluated. Primary outcome measurements are exercise capacity and which outcome measures influence survival. Secondary outcomes are respiratory and peripheral muscle strength, respiratory muscle endurance, pulmonary functions, physical activity, dyspnea and fatigue perception, depression and quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Investigator)
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 scheduled to undergo hematopoietic stem cell transplantation
- •under standard medications
- •18-65 years of age
排除标准
- •orthopedic or neurological disease with a potential to affect functional capacity,
- •comorbidities such as asthma, chronic obstructive pulmonary disease (COPD), acute infections or pneumonia,
- •have problems that can prevent evaluation,
- •take treatment other than standard medications during transplantation,
- •having acute hemorrhage in the intracranial and / or lung and other areas
- •having any contraindication to exercise training
结局指标
主要结局
Maximal exercise capacity
时间窗: Second day
Maximal exercise capacity will be evaluated symptom limited cardiopulmonary exercise testing. Oxygen consumption will be measured by cardiopulmonary exercise test. The cardiopulmonary exercise test will be performed on the treadmill at a progressively increasing speed and grade.
次要结局
- Pulmonary functions contains dynamic lung volumes(First day)
- Physical activity(First day)
- Disease Specific Quality of Life(First day)
- Peripheral muscle strength(First day)
- Fatigue(First day)
- Functional exercise capacity(First day)
- Respiratory muscle strength(First day)
- Depression(Second day)
- Respiratory muscle endurance(First day)
- Survival(100th day and first year)
研究者
Meral Boşnak Güçlü
Associate professor
Gazi University