Pulmonary HypertensionNCT03780803
Effect of Home Rehabilitation on State of Patients With PAH, HFREF and IHD
A study testing home cardiac rehabilitation and respiratory rehabilitation in people with Pulmonary Hypertension and Heart Failure With Reduced Ejection Fraction, run by Medical University of Bialystok at 1 site in Poland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Ischemic Heart Disease
- What is being tested?
- home cardiac rehabilitation and respiratory rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2016to 30 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Medical University of Bialystok, Department of Rehabilitation
Bialystok, Podlaskie Voivodeship, 15-089
About this study
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
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.
Read the 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 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
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Ischemic Heart Disease
- Being tested
- home cardiac rehabilitation and respiratory rehabilitation
- Keywords
- cardiac rehabilitation, pulmonary rehabilitation
- Medical subject headings
- Hypertension, Pulmonary, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home cardiac rehabilitation and respiratory rehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with PAH | Experimental | home cardiac rehabilitation and respiratory rehabilitation Receives: Other: home cardiac rehabilitation and respiratory rehabilitation |
| Patients with HFREF | Experimental | home cardiac rehabilitation and respiratory rehabilitation Receives: Other: home cardiac rehabilitation and respiratory rehabilitation |
| Patients with IHD | Experimental | home cardiac rehabilitation and respiratory rehabilitation Receives: Other: home cardiac rehabilitation and respiratory rehabilitation |
| Control group | No intervention | No rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (5)
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.
Measured: 6 months
Force of respiratory muscles
measurement of maximal inspiratory and expiratory pressure
Measured: 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
Measured: 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.
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start1 Feb 2016
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karol Kamiński, Professor, Study chair, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780803
- Sponsor's protocol ID
- N/ST/MN/16/002/1153
- Status last verified
- Feb 2021
- First submitted
- 13 Sep 2018
- Last updated
- 1 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28099988Mereles 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.
PubMed 16982941Zafrir 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.
PubMed 23962982Taylor 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.
PubMed 24771460Sagar 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.
PubMed 25685361Oldridge 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.
PubMed 23013125Heran 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.
PubMed 21735386Ciolkiewicz M, Wojciuk M, Kuryliszyn-Moskal A, Dakowicz A, Sawicka-Smiarowska E, Kaminski K. Beyond the clinic: a six-month home-based exercise and respiratory rehabilitation program improves functional capacity, respiratory muscle strength, and fatigue in chronic heart failure. Front Rehabil Sci. 2026 Oct 14;7:1958027. doi: 10.3389/fresc.2026.1958027. eCollection 2026.
PubMed 42952845Wojciuk 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.
PubMed 34321095
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03780803
- Acronym / sponsor ID
- N/ST/MN/16/002/1153
- Conditions
- Pulmonary Hypertension, Heart Failure With Reduced Ejection Fraction, Ischemic Heart Disease
- Keywords
- cardiac rehabilitation, pulmonary rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with PAH | Experimental | Other: home cardiac rehabilitation and respiratory rehabilitationhome cardiac rehabilitation and respiratory rehabilitation |
| Patients with HFREF | Experimental | Other: home cardiac rehabilitation and respiratory rehabilitationhome cardiac rehabilitation and respiratory rehabilitation |
| Patients with IHD | Experimental | Other: home cardiac rehabilitation and respiratory rehabilitationhome cardiac rehabilitation and respiratory rehabilitation |
| Control group | No intervention | –No rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home cardiac rehabilitation and respiratory rehabilitation | Other | Patients with HFREF, Patients with IHD, Patients with PAH |
Primary outcome
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
5 secondary outcomes
Evaluation of quality of life
Time frame: 6 months
Force of respiratory muscles
Time frame: 6 months
Clinical improvement - evaluation of WHO class
Time frame: 6 months
Evaluation of NYHA class
Time frame: 6 months
Evaluation of CCS class
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2021.
- Background: PubMed 28099988Morris 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.
- Background: PubMed 16982941Mereles 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.
- Background: PubMed 23962982Zafrir 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.
- Background: PubMed 24771460Taylor 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.
- Background: PubMed 25685361Sagar 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.
- Background: PubMed 23013125Oldridge 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.
- Background: PubMed 21735386Heran 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.
- Derived from this study: PubMed 42952845Ciolkiewicz M, Wojciuk M, Kuryliszyn-Moskal A, Dakowicz A, Sawicka-Smiarowska E, Kaminski K. Beyond the clinic: a six-month home-based exercise and respiratory rehabilitation program improves functional capacity, respiratory muscle strength, and fatigue in chronic heart failure. Front Rehabil Sci. 2026 Oct 14;7:1958027. doi: 10.3389/fresc.2026.1958027. eCollection 2026.
- Derived from this study: PubMed 34321095Wojciuk 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.
- Effectiveness and safety of a simple home-based rehabilitation program in pulmonary arterial hypertension: an interventional pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karol Kamiński, Professor study chair
Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home cardiac rehabilitation and respiratory rehabilitation in people with Pulmonary Hypertension and Heart Failure With Reduced Ejection Fraction, run by Medical University of Bialystok at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical improvement assesment of 6 MWT distance (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03780803, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2021.