Cardiopulmonary Function and Quality of Life in People With Sequelae of Pulmonary Tuberculosis Undergoing Pulmonary Rehabilitation: Controlled and Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Physical Capacity
研究概览
简要总结
This work aims to assess cardiopulmonary function and quality of life in people with sequelae of pulmonary tuberculosis undergoing rehabilitation. It is an experimental clinical study, with evaluation before and after the intervention. Included participants will be randomized and divided into a control group and an intervention group. Quality of life is examined by two questionnaires and physical fitness by specific tests, before and after the intervention. The intervention is the realization of a supervised physical exercise protocol.
详细描述
Experimental clinical study, with evaluation before and after intervention, for a determined period of two years for data collection and one year for analysis and publication of results. Included participants will be randomized and divided into a control group and an intervention group.
People with sequelae of pulmonary tuberculosis undergoing follow-up at the pulmonology outpatient clinic will be invited to participate in this study, with an estimated sample of 60 participants, according to the following criteria:
- Inclusion: people diagnosed with treated pulmonary tuberculosis, with negative culture in induced sputum; with pulmonary function report (spirometry), chest X-ray and complete blood count with biochemistry updated in the last month, and in accordance with the Informed Consent Form.
- Exclusion: people with non-cooperative pulmonary tuberculosis, who present clinical instability and / or musculoskeletal injury that compromises pulmonary rehabilitation and limits the perception of physical capacity; with any comorbidities that may cause or accentuate dyspnea; with stable angina, severe arrhythmias and / or heart failure.
Protocols:
- Anamnesis and medical record examination
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Pulmonary Tuberculosis,
- •negative culture in induced sputum;
- •pulmonary function report (spirometry), chest X-ray and complete blood count with biochemistry updated in the last month,
- •in accordance with the Informed Consent Form.
排除标准
- •Non-cooperative patients,
- •clinical instability and / or musculoskeletal injury that compromises Pulmonary Rehabilitation and limits the perception of physical capacity;
- •comorbidities that may cause or accentuate dyspnea (Asthma, COPD, Pulmonary Fibrosis, Obesity);
- •stable angina, severe arrhythmias and / or heart failure.
研究组 & 干预措施
Control Group
Frequent life activities.
Intervention Group
Protocol of physical exercises
干预措施: Physical rehabilitation (Other)
结局指标
主要结局
Physical Capacity
时间窗: 9 months
Comparison between a physical capacity evaluation
次要结局
- Quality of Life reported(9 months)
研究者
Diego de Faria Magalhães Torres
Diego de Faria Magalhães Torres
Universidade Federal do Rio de Janeiro