Evaluation of the Impact of a Pulmonary Rehabilitation Program on Exercise Capacity in Patients With Lymphangioleiomyomatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Endurance time during constant work rate cycle ergometry
研究概览
简要总结
Lymphangioleiomyomatosis (LAM) is a rare disease in which reduced exercise capacity is frequently present. The mechanisms applied are airflow obstruction, abnormal diffusion capacity and dynamic hyperinflation (DH).
Pulmonary rehabilitation (PR) has proved benefit in improving exercise tolerance, dyspnea, and quality of life in chronic obstructive pulmonary disease. There are no studies evaluating the impact of PR in patients with LAM.
The hypothesis under study is that PR determine improvement in exercise capacity, dyspnea, quality of life, muscle force, functional limitation and DH in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of lymphangioleiomyomatosis established by tissue biopsy and / or a combination of history and high-resolution computed tomography scanning
- •Clinical stability, defined as no exacerbations or hospitalizations related to the underlying disease for a minimum of 6 weeks and no change in the treatment regimen in the last 3 months
- •Low level of physical activity, defined as patients who walk less than 10 thousand daily steps and / or are not performing regular physical activity for at least 4 months before the start of rehabilitation
- •Signature of the free, prior and informed consent for participation in the study
排除标准
- •Lung transplant recipients
- •Musculoskeletal disorders that would prevent the patient from performing exercise training
- •Severe (NYHA IV) or uncontrolled heart disease
结局指标
主要结局
Endurance time during constant work rate cycle ergometry
时间窗: 12 weeks
次要结局
- Daily physical activity(12 weeks)
- Peak oxygen consumption (VO2 peak) during constant work rate cycle ergometry(12 weeks)
- Dynamic hyperinflation and ventilatory parameters during constant work rate cycle ergometry(12 weeks)
- Anxiety and depression(12 weeks)
- Changes in pulmonary function parameters(12 weeks)
- Dyspnea and functional disability related to daily life activities(12 weeks)
- Health factors related to quality of life(12 weeks)
- Changes in six minute walking distance and in desaturation - distance ratio (DDR)(12 weeks)
- Dyspnea and fatigue in the lower limbs during constant work rate cycle ergometry(12 weeks)
- Changes in peripheral muscle force(12 weeks)
研究者
Mariana Sponholz Araujo
Postgraduate student
University of Sao Paulo General Hospital