Ignite Creation Date:
2024-05-06 @ 12:32 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03780803
Status:
COMPLETED
Last Update Posted:
2021-11-01
First Post:
2018-09-13
Brief Title:
Effect of Home Rehabilitation on State of Patients With PAH HFREF and IHD
Sponsor:
Medical University of Bialystok
Organization:
Medical University of Bialystok
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 OrganisationNYHA New York Health AssociationCCS 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
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 OrganisationNYHA New York Health AssociationCCS 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None