"Effect of a Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis on Oxygen Consumption, Functionality, and Quality of Life"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Oxygen consumption peak
研究概览
简要总结
Interstitial Lung Disease associated with Systemic Sclerosis currently represents the main cause of death in this disease, it is also the cause of significant morbidity, which is why pulmonary rehabilitation strategies can be of great benefit in this group of patients. The aim of this study is to determine the effect of a 36-session supervised pulmonary rehabilitation program compared before and after, on oxygen consumption, functionality, and quality of life in Interstitial Lung
The main question it aims to answer are:
What effect will have with a 36-session supervised pulmonary rehabilitation program, compared before and after, on oxygen consumption, functionality and quality of life in Interstitial Lung Disease associated with Systemic Sclerosis, estimated by Cardiopulmonary Exercise Test, the questionnaire self-administered SySQ (systemic sclerosis functionality questionnaire) and the self-administered questionnaire SF-36.
Disease associated with Systemic Sclerosis. Study design: Quasi-experimental, longitudinal, comparative before and after study. Methods: Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis, at the Speciality Hospital of the National Medical Center La raza IMSS (Mexican Institute of Social Security), all those patients who wish to participate in the study will be asked to sign the informed consent letter, subsequently the Goldberg anxiety and depression questionnaire will be applied, as well as the SF-36 questionnaire to evaluate quality of life and SySQ to evaluate functionality, all participants will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test, the Pulmonary Function laboratory of the General Hospital National Medical Center La Raza IMSS . Subsequently, they will be sent to the Pulmonary Rehabilitation service, where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions (12 weeks). After the end of the program, respiratory function tests and tests will be performed again questionnaires, pulmonary function tests and cardiopulmonary exercise test.
详细描述
Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Interstitial Lung Disease associated Systemic Sclerosis, at the Speciality Hospital from the National Medical Center La Raza IMSS, all patients who wish to participate in the study will be asked to sign the informed consent letter from the participating researchers, subsequently the anxiety and depression questionnaire will be applied to them. Goldberg, as well as the SF-36 questionnaire to evaluate quality of life and the SySQ questionnaire to evaluate functionality, to include these data in the analysis, as well as history of smoking, occupational and environmental exposures to both biomass combustion smoke and inorganic powders, these questionnaires are validated in our population and have been widely used, the data corresponding to the time of evolution of the disease, medications used, comorbidities and levels of antibodies and acute phase reactants will be collected from the clinical records. of each of the participants. All participants (T0) will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity (DLCO) and Cardiopulmonary Exercise Test. The Pulmonary Function Laboratory of the National Medical Center General Hospital has qualified and trained personnel in performing respiratory function tests, the interpretation of said results will be carried out by the main author (doctoral student) who has a high specialty in Respiratory Physiology and Pulmonary Function Laboratory. Subsequently, the patients will be sent to the Pulmonary Rehabilitation service of the La Raza National Medical Center where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions, which is equivalent to 12 weeks. At the end of this period (T1), again the respiratory function tests (spirometry, plethysmography, DLCO, arterial blood gases and Cardiopulmonary Exercise Test) as well as the Goldberg, SF-36 and SySq questionnaires. The protocol has been submitted for approval to the National Health Research Committee (CNCI).
Study procedures. Every day prior to the start of the work day in the Pulmonary Function Laboratory of the National Medical Center La Raza IMSS, the cleaning and disinfection procedures of the equipment are carried out according to the manufacturer's requirements and the procedures are carried out. calibration, both for volume and flow linearity according to ATS/ERS 2005 standards for flow sensors, as well as linearity calibrations for the gas analyzer and pressure and temperature calibrations of the equipment.
Prior to performing the lung function tests, anthropometric measurements will be performed as follows:
- Height: with the patient in a standing position, height will be obtained with a wall stadiometer model 206 (Seca GMBH & Co., Hamburg, Germany). This measurement will be carried out by placing the heels together, close to the wall, as well as the calves, buttocks, shoulder blades and head. The head will be positioned by asking the patient to look forward, keeping the lateral canthus of the orbit horizontal in relation to the auditory meatus (Frankfort plane).
- Weight: with the patient wearing light clothing, the weight will be obtained using a precision digital scale model 813 (Seca GMBH & Co., Hamburg, Germany).
Goldberg Questionnaire for Anxiety and Depression The Goldberg Anxiety and Depression Scale is both a screening test, with healthcare and epidemiological uses, and an interview guide. It is a test that not only guides the diagnosis towards anxiety or depression (or both in mixed cases), but also discriminates between them and measures their respective intensities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of SSc, determined by the treating rheumatology service either from the Rheumatology and/or Internal Medicine Service of the Specialty Hospital of the National Medical Center La Raza IMSS , based on the ACR/EULAR 2013 criteria for SSc.
- •Time of evolution of the disease indistinct. You can be treated with any of the drugs in the spectrum of autoimmune disease treatment (immunosuppressants, steroids, biologics, etc.).
- •Diagnosis of Interstitial Lung Disease associated with SSc, confirmed by HRCT and FVC < 80% or TLC < 80% or DLCO < 80%.
排除标准
- •Chest, abdominal pain, oral or facial pain that prevents using the mouthpiece or forced expiration.
- •Stress incontinence, dementia or confusion.
- •Who have contraindications for performing physical effort.
- •Oxygen dependence that does not allow its withdrawal for more than 10 minutes.
- •Recent surgeries less than 1 month in case of thorax and upper abdomen and less than three months in case of retina and middle ear surgery.
- •Belonging to vulnerable groups (homeless people, prisoners, etc.)
- •Failure to obtain the informed consent signature
- •Presence of contraindication to exercise such as muscular or orthopedic injuries.
- •Who have presented disease activity data that would have required a change in pharmacological treatment in a period of less than 12 weeks prior to the start of the rehabilitation program.
结局指标
主要结局
Oxygen consumption peak
时间窗: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks), estimated by cardiopulmonary exercise test
Change in oxygen consumption of at least 1.15 ml/kg/min relative to the measurement before receiving the supervised pulmonary rehabilitation program, measured in ml/min.
Quality of life health related
时间窗: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)
Change in the score obtained in the SF36 quality of life questionnaire of at least 20% in relation to the baseline score obtained before receiving the 12-week supervised pulmonary rehabilitation program. Where 0 is the worst quality of life and 100 is the best quality of life, scores below 50 are considered poor quality of life.
Functionality
时间窗: t will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)
Change of 1 category in the score of the functionality scale for systemic sclerosis SySQ, in relation to the score obtained before entering the 12-week supervised pulmonary rehabilitation program. This scale includes an ability to perform an action section (0 = no difficulty, 1 = some difficulty, 2 = some difficulty, 3 = unable to do); another section describes the intensity of the symptoms (0 = no, 1 = mild, 2 = moderate, 3 = very severe), and finally there is a section on the frequency of the symptoms (0 = no, 1 = sometimes, 2 = often, 3 = always). The final score of the scale is calculated by averaging the maximum value obtained in each domain (block of questions) divided by 3 (given that there are 3 domains), and that value goes from 0 (normal functionality) to 3 (minimal functionality)
次要结局
未报告次要终点