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临床试验/NCT06127641
NCT06127641招募中不适用

Rehabilitation of People With Post-tuberculosis Lung Disease

Centro Universitário Augusto Motta4 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年10月28日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
40
试验地点
4
主要终点
Functional capacity using the ADL-Glittre test (TGlittre) incorporated into dynamic ventilation before and after the PR program

研究概览

简要总结

Tuberculosis (TB) can leave numerous sequelae, where survivors experience a transition from an acute illness to living with a multifaceted chronic illness. Post-TB lung disease (PD-PTB) encompasses lung diseases and pathologies that occur after one or more episodes of TB, which can affect the patient's lung health and cause disabling symptoms that strongly affect their long-term health. In 2020, it was estimated that there were 155 million TB survivors still alive worldwide, with a large proportion of them carrying functional sequelae with profound socioeconomic repercussions. Thus, the aim of this study is to evaluate the effect of pulmonary rehabilitation (PR) on functionality and health-related quality of life (HRQoL) of people with PD-PTB and to build a PD-PTB severity scoring system based on the data. of pre-RP individuals using artificial intelligence technique.

详细描述

Tuberculosis (TB) can leave numerous sequelae, where survivors experience a transition from an acute illness to living with a multifaceted chronic illness. Post-TB lung disease (PD-PTB) encompasses lung diseases and pathologies that occur after one or more episodes of TB, which can affect the patient's lung health and cause disabling symptoms that strongly affect their long-term health. In 2020, it was estimated that there were 155 million TB survivors still alive worldwide, with a large proportion of them carrying functional sequelae with profound socioeconomic repercussions. Thus, the aim of this study is to evaluate the effect of pulmonary rehabilitation (PR) on functionality and health-related quality of life (HRQoL) of people with PD-PTB and to build a PD-PTB severity scoring system based on the data. of pre-RP individuals using artificial intelligence technique. This is a randomized controlled trial, in which the sample will be divided into two groups: intervention for 12 weeks with PR and standard care. Functional capacity will be evaluated pre- and post-PR through the Glittre-ADL test with incorporation of dynamic ventilation, lung function (including impulse oscillometry), respiratory and peripheral muscle function, general fatigue and HRQoL. It is expected that PTB-PD patients will benefit significantly and, therefore, be able to (re)enter society, especially in job market.

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 (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with post-tuberculosis lung disease, clinically stable and able to perform >80% of training sessions.

排除标准

  • Presence of comorbidities not related to PD-PTB.
  • Patients with inability to perform TGlittre.
  • Patients who have cognitive changes that impair their inclusion in the study.
  • Treatment abandonment during the application of the PR protocol.
  • Uncontrolled hypertension or use of psychotropic medications.
  • Any significant limitations due to osteoarthropathy.
  • Having had any orthopedic surgery in the previous year.

结局指标

主要结局

Functional capacity using the ADL-Glittre test (TGlittre) incorporated into dynamic ventilation before and after the PR program

时间窗: an average of 4 years

Executed as proposed by Skumlien et al. (2006). The shorter duration TGlittre will be used for analysis and comparison to predicted values for healthy brazilians (REIS et al., 2018). Furthermore, the device Spiropalm 6MWT, Cosmed, Rome, Italy, will be attached to the patient. Inspiratory capacity (IC) will be obtained before and after TGlittre, and a ≥100 mL decrease in IC (∆IC) during exertion will be defined as dynamic hyperinflation (TOSUN et al., 2022). Other dynamic ventilatory responses assessed: minute ventilation (VE) and ventilatory reserve (RV). The latter indicates how close VE comes to maximum ventilation during a given activity, and will be calculated as the difference between maximum voluntary ventilation (MVV) and VEpeak (\[MVV - VEpeak\]/VVM); VR \<30% will be considered exertional ventilation limitation (LOPES et al., 2011a). The MVV will be automatically determined by the device as 40 multiplied by FEV1

次要结局

  • Clinical-functional assessment(an average of 4 years)
  • Handgrip strength (HGS)(an average of 4 years)
  • Pulmonary function measurements(an average of 4 years)
  • Saint George's Respiratory Questionnaire (SGRQ)(an average of 4 years)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)(an average of 4 years)
  • Quadriceps strength (QS)(an average of 4 years)

研究者

发起方
Centro Universitário Augusto Motta
申办方类型
Other
责任方
Sponsor

研究点 (4)

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