Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03780803
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : January 22, 2020
Sponsor:
Information provided by (Responsible Party):
Medical University of Bialystok

Brief Summary:
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.

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

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 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
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.


  2. Force of respiratory muscles [ Time Frame: 6 months ]
    measurement of maximal inspiratory and expiratory pressure

  3. 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

  4. 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.

  5. 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


Other Outcome Measures:
  1. 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).

  2. Weight [ Time Frame: 6 months ]
    measurement of weight in kilograms

  3. Concentration of BNP (brain natriuretic peptide) [ Time Frame: 6 months ]
    Biochemical analyses - serum concentrations of brain natriuretic peptide (BNP) pg/ml

  4. Concentration of creatinine [ Time Frame: 6 months ]
    Measurement of serum concentrations of creatinine mg/dl

  5. Concentration of uric acid [ Time Frame: 6 months ]
    Measurement of serum concentrations of uric acid mg/dl

  6. Concentration of total cholesterol [ Time Frame: 6 months ]
    Measurement of serum concentrations of total cholesterol mg/dl

  7. Concentration of LDL [ Time Frame: 6 months ]
    Measurement of serum concentrations of LDL (low density lipoprotein) mg/dl

  8. Concentration of HDL [ Time Frame: 6 months ]
    Measurement of serum concentrations of HDL (high density lipoprotein) mg/dl

  9. Concentration of triglycerides [ Time Frame: 6 months ]
    Measurement of serum concentrations of triglycerides mg/dl

  10. Concentration of CRP [ Time Frame: 6 months ]
    Measurement of serum concentrations of CRP (C-reactive protein) mg/dl

  11. Concentration of fasting glucose [ Time Frame: 6 months ]
    Measurement of serum concentrations of fasting glucose mg/dl

  12. Activity of TSH [ Time Frame: 6 months ]
    Measurement of serum activity of TSH mU/l,

  13. Concentration of Troponin I [ Time Frame: 6 months ]
    Measurement of serum concentrations of troponin I µg/l,

  14. Number of WBC [ Time Frame: 6 months ]
    Measurement of number of WBC (white blood cells) K/µl,

  15. Number of RBC [ Time Frame: 6 months ]
    Measurement of number of RBC (red blood cells ) M/µl

  16. Concentration of Hemoglobin [ Time Frame: 6 months ]
    Measurement of serum concentrations of Hgb (hemoglobin) g/dl

  17. Concentration of P selectin [ Time Frame: 6 months ]
    Measurement of serum concentrations of P selectin, ng/ml

  18. Concentration of Il-6 [ Time Frame: 6 months ]
    Measurement of serum concentrations of interleukin 6 (IL-6) pg/ml

  19. Concentration of sIl-6 R [ Time Frame: 6 months ]
    Measurement of serum concentrations of soluble Interleukin 6 receptor (sIL-6R),ng/ml

  20. Concentration of SDF-1 [ Time Frame: 6 months ]
    Measurement of serum concentrations of stromal derived factor-1 (SDF-1, CXCL12), ng/ml

  21. Concentration of sTWEAK [ Time Frame: 6 months ]
    Measurement of serum concentrations of soluble tumor necrosis factor-like weak inducer of apoptosis (sTWEAK). pg/ml

  22. Percentage of stem cells [ Time Frame: 6 months ]
    assesment of amount of stem cells (percentage of undifferentiated cells)

  23. percentage of subpopulations of monocytes [ Time Frame: 6 months ]
    profile of subpopulations of monocytes (percentage)



Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Mariusz J Ciołkiewicz, PhD 0048858318315 mariusz.ciolkiewicz@umb.edu.pl
Contact: Karol Kamiński, Professor 0048856865371 medycyna.populacyjna@umb.edu.pl

Locations
Layout table for location information
Poland
Medical University of Bialystok, Department of Rehabilitation Recruiting
Białystok, Podlaskie, Poland, 15-089
Contact: Mariusz J Ciołkiewicz, Phd    0048858318315 ext 0048858318315    mariusz.ciolkiewicz@umb.edu.pl   
Contact: Karol Kamiński, Professor    0048856865371    medycyna.populacyjna@umb.edu.pl   
Sponsors and Collaborators
Medical University of Bialystok
Investigators
Layout table for investigator information
Study Chair: Karol Kamiński, Professor Medical University of Bialystok
Publications:

Layout table for additonal information
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: January 22, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medical University of Bialystok:
cardiac rehabilitation
pulmonary rehabilitation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension, Pulmonary
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases