Effect of Home Rehabilitation on State of Patients With PAH, HFREF and IHD

Study Overview
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Brief Summary
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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.

Detailed Description
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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. During first visit also ECG (electrocardiogram) and echocardiography will be done. The safe protocol of home physical training and respiratory rehabilitation adjusted to the clinical state of patients will be developed in the form of brochure with photos and precise description of exercises and the diary of self-control of patient in order to collect data regarding daily physical activity will be given to participants. Patients willing to take part in stage of exercises (circa 45 persons) will be trained in Rehabilitation Department how to perform exercises at homes. Easy to use devices dedicated to respiratory exercises (Pulmogain Respitrain) enabling respiratory muscles training with various degree of intensity and pedometers to assess daily motor activity will be given to patients. Stage of exercises during which the next series of tests will be performed will last 6 months. Exercising patients will come to Rehabilitation Department on first and third month after start of rehabilitation in order to control the correctness of training performance, filling self-control diary assessment of patients compliance and eventual corrections of training program. Patients will be also under continuous phone supervision (minimally once a week) and in the case of doubts and need for consultation. After finishing exercises stage and performed clinical evaluation, patients will by themselves decide if they are willing to continue rehabilitation (will have possibility of further use of physiotherapists care), and follow up assessment will take place after 6 months from finishing exercises stage. Comparative group will consist of patients with PAH, HF-REF, IHD who agreed to participate in study but were not qualified to the exercises stage. Control group will consist of patients of Cardiology Department and Cardiology Outpatient Clinic and Rehabilitation Department (without cardiovascular diseases). Range of examinations in control group will consists of medical anamnesis, physical examination, anthropometric measures, individually filled questionnaires SF-36 and FSS, evaluation of respiratory muscles force, hand grip strength and analysis of body mass composition BIA.

Official Title
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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

Conditions
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Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Ischemic Heart Disease

Intervention / Treatment
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* Other: home cardiac rehabilitation and respiratory rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with PAH<br>home cardiac rehabilitation and respiratory rehabilitation | Other: home cardiac rehabilitation and respiratory rehabilitation<br> <br> |
| Experimental: Patients with HFREF<br>home cardiac rehabilitation and respiratory rehabilitation | Other: home cardiac rehabilitation and respiratory rehabilitation<br> <br> |
| Experimental: Patients with IHD<br>home cardiac rehabilitation and respiratory rehabilitation | Other: home cardiac rehabilitation and respiratory rehabilitation<br> <br> |
| No Intervention: Control group<br>No rehabilitation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement assesment of 6 MWT distance | 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 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of quality of life | Quality of life measurement with SF36 (The Short Form (36) Health Survey, which is a 36-item, patient-reported survey of patient health.The Optum™ SF-36v2® Health Survey asks 36 questions to measure functional health and well-being from the patient's point of view. It is a practical, reliable and valid measure of physical and mental health that can be completed in five to ten minutes. The more number of points witness of better quality of life. Scores are calibrated so that 50 is the average score or norm. This norm-based score allows comparison among the three surveys and across the more than 19,000 studies published in the past 20 years. This bibliography includes studies of hundreds of diseases, conditions and populations, and greatly enhances the ability to interpret SF health survey data in new studies. | 6 months | 
| Force of respiratory muscles | measurement of maximal inspiratory and expiratory pressure | 6 months | 
| Clinical improvement - evaluation of WHO class | Patients' functional status is assessed with use of World Health Organisation (WHO) for pulmonary arterial hypertension. Best status is class I, worst status is class IV | 6 months | 
| Evaluation of NYHA class | Patients' functional status is assessed with use of New York Heart Association (NYHA) classification for heart failure, best status is class I, worst status is class IV. | 6 months | 
| Evaluation of CCS class | Patients' functional status is assessed with use of Canadian Cardiovascular Society (CCS) classification for coronary artery disease. Best status is class I, worst status is class IV | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac rehabilitation, pulmonary rehabilitation