Effect of Home Rehabilitation on State of Patients With PAH, HFREF and IHD
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ClinicalTrials.gov Identifier: NCT03780803 |
Recruitment Status :
Completed
First Posted : December 19, 2018
Last Update Posted : November 1, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pulmonary Hypertension Heart Failure With Reduced Ejection Fraction Ischemic Heart Disease | Other: home cardiac rehabilitation and respiratory rehabilitation | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 93 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Other |
Official Title: | 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 |
Actual Study Start Date : | February 1, 2016 |
Actual Primary Completion Date : | September 30, 2021 |
Actual Study Completion Date : | September 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Patients with PAH
home cardiac rehabilitation and respiratory rehabilitation
|
Other: home cardiac rehabilitation and respiratory rehabilitation |
Experimental: Patients with HFREF
home cardiac rehabilitation and respiratory rehabilitation
|
Other: home cardiac rehabilitation and respiratory rehabilitation |
Experimental: Patients with IHD
home cardiac rehabilitation and respiratory rehabilitation
|
Other: home cardiac rehabilitation and respiratory rehabilitation |
No Intervention: Control group
No rehabilitation
|
- Clinical improvement assesment of 6 MWT distance [ Time Frame: 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
- Evaluation of quality of life [ Time Frame: 6 months ]
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.
- Force of respiratory muscles [ Time Frame: 6 months ]measurement of maximal inspiratory and expiratory pressure
- Clinical improvement - evaluation of WHO class [ Time Frame: 6 months ]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
- Evaluation of NYHA class [ Time Frame: 6 months ]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.
- Evaluation of CCS class [ Time Frame: 6 months ]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
- Body mass composition in patients with PAH [ Time Frame: 6 months ]Bioelectrical impedance analysis of body mass composition- body fat (amount of body fat in kilograms), body fat (amount of body fat percentage), body muscle content (amount of body muscles in kilograms), body muscle content (amount of body muscles percentage), water content (amount of water in kilograms), water content (amount of water percentage), organic substances content (amount of organic substances in kilograms), organic substances content (amount of organic substances percentage).
- Weight [ Time Frame: 6 months ]measurement of weight in kilograms
- Concentration of BNP (brain natriuretic peptide) [ Time Frame: 6 months ]Biochemical analyses - serum concentrations of brain natriuretic peptide (BNP) pg/ml
- Concentration of creatinine [ Time Frame: 6 months ]Measurement of serum concentrations of creatinine mg/dl
- Concentration of uric acid [ Time Frame: 6 months ]Measurement of serum concentrations of uric acid mg/dl
- Concentration of total cholesterol [ Time Frame: 6 months ]Measurement of serum concentrations of total cholesterol mg/dl
- Concentration of LDL [ Time Frame: 6 months ]Measurement of serum concentrations of LDL (low density lipoprotein) mg/dl
- Concentration of HDL [ Time Frame: 6 months ]Measurement of serum concentrations of HDL (high density lipoprotein) mg/dl
- Concentration of triglycerides [ Time Frame: 6 months ]Measurement of serum concentrations of triglycerides mg/dl
- Concentration of CRP [ Time Frame: 6 months ]Measurement of serum concentrations of CRP (C-reactive protein) mg/dl
- Concentration of fasting glucose [ Time Frame: 6 months ]Measurement of serum concentrations of fasting glucose mg/dl
- Activity of TSH [ Time Frame: 6 months ]Measurement of serum activity of TSH mU/l,
- Concentration of Troponin I [ Time Frame: 6 months ]Measurement of serum concentrations of troponin I µg/l,
- Number of WBC [ Time Frame: 6 months ]Measurement of number of WBC (white blood cells) K/µl,
- Number of RBC [ Time Frame: 6 months ]Measurement of number of RBC (red blood cells ) M/µl
- Concentration of Hemoglobin [ Time Frame: 6 months ]Measurement of serum concentrations of Hgb (hemoglobin) g/dl
- Concentration of P selectin [ Time Frame: 6 months ]Measurement of serum concentrations of P selectin, ng/ml
- Concentration of Il-6 [ Time Frame: 6 months ]Measurement of serum concentrations of interleukin 6 (IL-6) pg/ml
- Concentration of sIl-6 R [ Time Frame: 6 months ]Measurement of serum concentrations of soluble Interleukin 6 receptor (sIL-6R),ng/ml
- Concentration of SDF-1 [ Time Frame: 6 months ]Measurement of serum concentrations of stromal derived factor-1 (SDF-1, CXCL12), ng/ml
- Concentration of sTWEAK [ Time Frame: 6 months ]Measurement of serum concentrations of soluble tumor necrosis factor-like weak inducer of apoptosis (sTWEAK). pg/ml
- Percentage of stem cells [ Time Frame: 6 months ]assesment of amount of stem cells (percentage of undifferentiated cells)
- percentage of subpopulations of monocytes [ Time Frame: 6 months ]profile of subpopulations of monocytes (percentage)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03780803
Poland | |
Medical University of Bialystok, Department of Rehabilitation | |
Białystok, Podlaskie, Poland, 15-089 |
Study Chair: | Karol Kamiński, Professor | Medical University of Bialystok |
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Medical University of Bialystok |
ClinicalTrials.gov Identifier: | NCT03780803 |
Other Study ID Numbers: |
N/ST/MN/16/002/1153 |
First Posted: | December 19, 2018 Key Record Dates |
Last Update Posted: | November 1, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
cardiac rehabilitation pulmonary rehabilitation |
Hypertension, Pulmonary Heart Diseases Myocardial Ischemia Coronary Artery Disease Hypertension Vascular Diseases |
Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |