Evaluation of Respiratory Function in Patients With Post-tuberculosis Lung Impairment After Pulmonary Tuberculosis Treatment or After Spontaneous Healing
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 6-min walking test
研究概览
简要总结
Pulmonary tuberculosis (TB) is an important risk factor for chronic respiratory disease due to residual lung damage. A recent review of the literature on TB sequelae and rehabilitation has provided clear evidence that TB is definitively responsible for lung function impairment. Functional evaluation of TB patients after completion of pulmonary tuberculosis treatment or spontaneous healing should be considered as part of clinical care. Unfortunately, few studies are available in the literature investigating the physiopathology of lung damage, its impact on quality of life, the potential need for pulmonary rehabilitation (PR), and the effects of a PR program.Objectives of this prospective multicentre international study are: Primary Objective-to assess the exercise capacity 6-min walking test in patients with post-TB lung impairment after completion of pulmonary tuberculosis treatment or after spontaneous healing. Secondary Objectives-to assess the effects of the PR program on dyspnoea symptoms and muscle fatigue, quality of life.
详细描述
Methods Respiratory functional parameters at baseline and at the end of the 15 sessions rehabilitation programme (RP) will be collected at the participating Centre. Follow-up visit 1 year after completion of RP Baseline assessment
- After signature of the informed consent to the study, patients will undergo a Pre-screening Visit: data on medical history, current pharmacological therapies, smoking (pack/year), vaccinations, physical examination, vital parameters (blood pressure, heart rate, respiratory rate, oxygen saturation in arterial blood), co-morbidities and Mini Mental State Examination will be collected.
- Screening Visit (before the RP), during the visit the following data will be collected: number of TB disease episodes, detailed data on the last TB episode (age at onset of TB symptoms, age at TB diagnosis, anti-TB treatment duration, anti-TB drugs administered, socio-economic conditions, education level, physical examination, vital parameters, oxygen saturation in arterial blood, heart rate and respiratory rate). Pulmonary rehabilitation program tailored according to specific patient's needs.
- Baseline assessment of respiratory function: arterial blood gas (ABG) analysis, spirometry, diffusing capacity of the lungs for carbon monoxide (DLCO), overnight oximetry, electrocardiogram (ECG), chest X-ray (CXR), High-resolution computed tomography (HRCT)
- Assessment of the rehabilitation programme: functional evaluation (6MWT), muscle strength evaluation (five-repetition sit-to-stand test (5STS)), respiratory muscle strength (maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP)), symptoms evaluation (Dyspnea: Medical Research Council Questionnaire (MRC), Modified Borg pre/post 6MWT, Baseline and Transition Dyspnea Indexes (BDI-TDI) and Fatigue: Modified Borg pre/post 6MWT)
- Assessment of the Quality of Life (QoL): CAT and St George's Respiratory Questionnaire.
Final assessment:
A final assessment will be done at the end of the rehabilitation programme and will include:
c) Only ABG, spirometry and DLCO d) and e).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with post-TB lung impairment after completion of pulmonary tuberculosis treatment - Patients with post- TB impairment after spontaneous healing
排除标准
- •Any unstable medical condition
- •Musculoskeletal disorders contraindicating participation in the PR program
- •Cognitive impairment (Mini Mental State Examination <22)
- •Unable to sign informed consent
研究组 & 干预措施
pulmonary rehabilitation
Pulmonary rehabilitation program
干预措施: Pulmonary Rehabilitation (Procedure)
结局指标
主要结局
6-min walking test
时间窗: 1 year
Exercise capacity
次要结局
- muscle fatigue(1 year)
- health related quality of life(1 year)
- health status(1 year)
- dyspnoea(1 year)
研究者
Dina Visca
Principal Investigator
Università degli Studi dell'Insubria