Effect of Home Rehabilitation on State of Patients With PAH, HFREF and IHD
NCT ID: NCT03780803
Last Updated: 2021-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
93 participants
INTERVENTIONAL
2016-02-01
2021-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Patients with PAH
home cardiac rehabilitation and respiratory rehabilitation
home cardiac rehabilitation and respiratory rehabilitation
Patients with HFREF
home cardiac rehabilitation and respiratory rehabilitation
home cardiac rehabilitation and respiratory rehabilitation
Patients with IHD
home cardiac rehabilitation and respiratory rehabilitation
home cardiac rehabilitation and respiratory rehabilitation
Control group
No rehabilitation
No interventions assigned to this group
Interventions
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home cardiac rehabilitation and respiratory rehabilitation
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Medical University of Bialystok
OTHER
Responsible Party
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Principal Investigators
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Karol Kamiński, Professor
Role: STUDY_CHAIR
Medical University of Bialystok
Locations
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Medical University of Bialystok, Department of Rehabilitation
Bialystok, Podlaskie Voivodeship, Poland
Countries
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References
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Morris NR, Kermeen FD, Holland AE. Exercise-based rehabilitation programmes for pulmonary hypertension. Cochrane Database Syst Rev. 2017 Jan 19;1(1):CD011285. doi: 10.1002/14651858.CD011285.pub2.
Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grunig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18.
Zafrir B. Exercise training and rehabilitation in pulmonary arterial hypertension: rationale and current data evaluation. J Cardiopulm Rehabil Prev. 2013 Sep-Oct;33(5):263-73. doi: 10.1097/HCR.0b013e3182a0299a.
Taylor RS, Sagar VA, Davies EJ, Briscoe S, Coats AJ, Dalal H, Lough F, Rees K, Singh S. Exercise-based rehabilitation for heart failure. Cochrane Database Syst Rev. 2014 Apr 27;2014(4):CD003331. doi: 10.1002/14651858.CD003331.pub4.
Sagar VA, Davies EJ, Briscoe S, Coats AJ, Dalal HM, Lough F, Rees K, Singh S, Taylor RS. Exercise-based rehabilitation for heart failure: systematic review and meta-analysis. Open Heart. 2015 Jan 28;2(1):e000163. doi: 10.1136/openhrt-2014-000163. eCollection 2015.
Oldridge N. Exercise-based cardiac rehabilitation in patients with coronary heart disease: meta-analysis outcomes revisited. Future Cardiol. 2012 Sep;8(5):729-51. doi: 10.2217/fca.12.34.
Heran BS, Chen JM, Ebrahim S, Moxham T, Oldridge N, Rees K, Thompson DR, Taylor RS. Exercise-based cardiac rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2011 Jul 6;(7):CD001800. doi: 10.1002/14651858.CD001800.pub2.
Wojciuk M, Ciolkiewicz M, Kuryliszyn-Moskal A, Chwiesko-Minarowska S, Sawicka E, Ptaszynska-Kopczynska K, Kaminski K. Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension: an interventional pilot study. BMC Sports Sci Med Rehabil. 2021 Jul 28;13(1):79. doi: 10.1186/s13102-021-00315-y.
Related Links
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Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension: an interventional pilot study
Other Identifiers
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N/ST/MN/16/002/1153
Identifier Type: -
Identifier Source: org_study_id