Evaluation of Influence of Home Physical Training Program and Respiratory Rehabilitation on Quality of Life, Body Composition, and Function of Respiratory Muscles in Patients With Primary PAH, HFREF and IHD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 93
- 试验地点
- 2
- 主要终点
- Clinical improvement assesment of 6 MWT distance
研究概览
简要总结
The aim of the study is to evaluate the influence of physical training and respiratory rehabilitation performed by patients at home on quality of life, symptoms, physical endurance, force of respiratory and skeletal muscles and body mass composition in patients with pulmonary arterial hypertension (PAH) or left ventricular heart failure with reduced ejection fraction - HFREF), or ischemic heart disease and evaluation the number of stem cells, natural lymphoid cells and distribution of subpopulations of monocytes (including proangiogenic monocytes) in examined persons and evaluation of theirs eventual influence of the course of disease.
详细描述
The study will be conducted on total group of 100 participants, from which 75 will be the patients with PAH (pulmonary arterial hypertension), HF-REF (heart failure with reduced ejection fraction) or IHD (ischemic heart disease).
In all participants medical anamnesis, physical examination, anthropometric measures, 6-minute walking distance (6MWD six minute walking distance) will be performed and initial functional class according WHO (World Health Organisation)/NYHA (New York Health Association)/CCS (Canadian Cardiovascular Society) classification will be evaluated. Medical history will consist of questions regarding coexisting diseases, treatment, lifestyle, family burden, etc. Quality of life will be assessed with use of The Short Form (36) Health Survey - SF-36) and Fatigue Severity Scale - FSS. Biochemical measures will be performed including, among others. brain natriuretic peptide (BNP), blood morphology, P-selectin, concentrations of cytokines such as : Interleukin 6 (IL-6), soluble Interleukin 6 receptor (sIL-6R), stromal derived factor-1 (SDF-1, CXCL12) and soluble tumor necrosis factor-like weak inducer of apoptosis (sTWEAK).
Among lab parameters routinely measured in groups of patients with PAH, HFREF, IHD performed in Cardiology Department of University Clinical Hospital during hospitalization will be used: creatinine level, uric acid level, total cholesterol, LDL (low density lipoprotein), HDL (high density lipoprotein), triglycerides levels, troponin I level, CRP (C reactive protein), BNP (brain natriuretic peptide), fasting glucose, TSH (thyroid stimulating hormone), blood morphology and arterial geometry. Fasting venous blood will be collected in 4 tubes each a 10 ml. Two tubes a 10ml (one dedicated to obtain serum ("on clot"), second with heparin) to perform biochemical analyses, tube a 10ml with EDTA (ethylenediaminetetraacetic acid) will be used to evaluate PBMC (peripheral blood mononuclear cell) (density gradient centrifugation), tube a 10ml with citrate will be used to obtain platelet lysate.
Additionally fasting venous blood will be obtained - 2 tubes a 10ml in order to assess number of stem cells, natural lymphoid cells, and distribution of subpopulations of lymphocytes.
In clinical evaluation measurement of respiratory (inspiratory and expiratory) muscles force with use of device MicroRPM (respiratory pressure meter), analysis of body mass composition with special regard to muscular mass with use of bioelectrical impedance analysis method (BIA) (Maltron) and measurement of hand grip strength with use of hand dynamometer will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >18 years
- •informed consent signed by patient to conduct the study
- •no diseases excluding rehabilitation
- •pts with idiopathic, inherited PAH (pulmonary arterial hypertension), or in the course of connective tissue diseases, portal hypertension, congenital heart diseases.
- •PAH confirmed in catheterisation of right side of heart mPAP (mean pulmonary arterial pressure) ≥25 mmHg, PCWP (pulmonary capillary wedge pressure) ≤15mmHg.
- •Chronic heart failure - left ventricle ejection fraction <40% in echocardiography, NYHA *New York Health Association) class II-III
- •stable ischaemic heart disease in CCS (Canadian Cardiovascular Society) class II-III
排除标准
- •Other types of pulmonary hypertension
- •COPD (chronic obstructive pulmonary disease), asthma
- •malignancies
- •Acute inflammatory state up to 4 weeks before inclusion to the study
- •Acute coronary syndrome up to 3 months before inclusion to the study
- •Heart failure in NYHA IV class
- •severe anaemia (Hgb <11g/dl for men <10g/dl for women)
- •electrolyte and hormonal disturbances in period of 1 month before inclusion to the study
- •substantial modification of treatment of main disease within last 3 months
- •ischaemic heart disease in CCS class IV
- •Other clinical situations excluding to perform controlled program of rehabilitation
结局指标
主要结局
Clinical improvement assesment of 6 MWT distance
时间窗: 6 months
6-min walk test (6 MWT) is a exercise test that entails measurement of distance walked over a span of 6 minutes by patient good outcome \> 500 m, bad outcome \< 200 m
次要结局
- Evaluation of quality of life(6 months)
- Evaluation of NYHA class(6 months)
- Evaluation of CCS class(6 months)
- Force of respiratory muscles(6 months)
- Clinical improvement - evaluation of WHO class(6 months)