Coronary Artery DiseaseRT in CVDNCT04638764
Resistance Training in Cardiovascular Disease Patients
A study testing Aerobic interval training combined with high intensity resistance training, Aerobic interval training combined with low intensity resistance training and Aerobic interval training in people with Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by General Hospital Murska Sobota at 1 site in Slovenia.
Trial summary
In this study coronary artery disease patients and patients with heart failure will be randomly assigned to three training groups: combined aerobic interval training with high intensity resistance training, combined aerobic interval training with low intensity resistance training and aerobic interval training. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Disease, Heart Failure With Reduced Ejection Fraction
- What is being tested?
- Aerobic interval training combined with high intensity resistance training, Aerobic interval training combined with low intensity resistance training and Aerobic interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteSlovenia
- Study dates
- 23 Nov 2020to 26 Nov 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
- Stable patients with documented CAD with clinical event (>1 month after acute coronary syndrome and/or percutaneous coronary intervention) or coronarography and/or
- Stable Heart Failure patients with documented reduced ejection fraction (>40-45 %)
- age >18 years
- NYHA class I-III
- Cardiopulmonary exercise test without ECG abnormalities
Who cannot join
- Unstable CHD
- Decompensated HF
- Uncontrolled arrhythmias
- Severe and symptomatic aortic stenosis
- Acute myocarditis, endocarditis, or pericarditis
- Aortic dissection
- Marfan syndrome
- Musculoskeletal limitations
Trial locations and contacts
1 site in 1 country.
Tim Kambič, MKin contact
Slovenia1 site, 1 recruiting
- Recruiting
Division of Cardiology, General Hospital Murska Sobota
Murska Sobota, 9000
Mitja Lainščak, MD, PhD, mitja.lainscak@guest.arnes.si
Tim Kambič, MKin, tim.kambic@gmail.com
About this study
Official title: Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation
In this study coronary artery disease patients and patients with heart failure will be randomly assigned to three training groups: combined aerobic interval training with high intensity resistance training, combined aerobic interval training with low intensity resistance training and aerobic interval training.
Read the detailed description
Exercise-based cardiac rehabilitation programmes have predominantly used aerobic-dynamic exercise modalities, whereas resistance training have been discouraged in patients with cardiovascular disease, due to safety concerns related to cardiovascular response (heart rate and blood pressure) during the exertion. Contrary to such concerns, recent hemodynamic studies have reported lower blood pressure and heart rate during higher intensity resistance training (>70 % 1-RM) compared to lower intensity resistance training (>40 % 1-RM). Furthermore, the latest meta analysis have demonstrated that combined resistance training with standard aerobic interval training has been superior than aerobic training alone in several aspects of health.
However, there is still huge heterogeneity in training intervention design, also there still lacks studies to further elucidate the effects of high intensity resistance training combined with aerobic training on physical performance (aerobic capacity, muscle strength, balance), body composition, quality of life, morbidity, mortality, etc. Therefore, the aim of this study was to examine the effects of high (70%-80 % 1-RM) versus low loads (30%- 40 % 1-RM) resistance training in combination with aerobic interval cycling (50 % -80% of baseline peak Power output) in coronary artery disease patients and patients with heart failure.
- Being tested
- Aerobic interval training combined with high intensity resistance training, Aerobic interval training combined with low intensity resistance training, Aerobic interval training
- Keywords
- resistance training, coronary artery disease, heart failure, hemodynamic response, cardiac rehabilitation, aerobic training
- Medical subject headings
- Coronary Artery Disease, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic interval training combined with high intensity resistance trainingOther
Also called Aerobic and high intensity strength training
Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 70 %- 80 % of one repetition maximum (1-RM)).
Aerobic interval training combined with low intensity resistance trainingOther
Also called Aerobic and low intensity strength training
Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 30 %- 40 % 1-RM).
Aerobic interval trainingOther
Also called Aerobic training
Patients enrolled in arm of the study will perform 12 weeks of aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing).
| Study group | Role | What they receive |
|---|---|---|
| Aerobic interval training with high loads resistance training | Active comparator | Patient to be randomised into "combined aerobic training with high loads resistance training group". Receives: Other: Aerobic interval training combined with high intensity resistance training |
| Aerobic interval training with low loads resistance training | Active comparator | Patient to be randomised into "combined aerobic training with low loads resistance training group". Receives: Other: Aerobic interval training combined with low intensity resistance training |
| Aerobic interval training | Active comparator | Patient to be randomised into "aerobic training training group". Receives: Other: Aerobic interval training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal aerobic capacity
Measured as change in VO2 max (ml/kg/min)
Measured: Change in maximal aerobic capacity at 12 weeks compared to baseline
Change in Maximal voluntary contraction of knee extensors
Measured as change in maximal isometric torque of knee extensors
Measured: Change in maximal isometric torque at 12 weeks compared to baseline
Secondary outcomes (28)
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Measured as change in HOMA IR (%)
Measured: Change in HOMA-IR at 12 weeks compared to baseline
Change in glucose levels
Measured as change in glucose levels (mmol/L)
Measured: Change in glucose levels at 12 weeks compared to baseline
Change in insulin levels
Measured as change in insulin levels
Measured: Change in insulin levels at 12 weeks compared to baseline
Change in systolic blood pressure during high and low load resistance exercise
Measured as change in systolic blood pressure during resistance exercise compared to baseline (pre-exercise) values
Measured: Change of systolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in diastolic blood pressure during high and low load resistance exercise
Measured as change in diastolic blood pressure during resistance exercise compared to baseline (pre-exercise)
Measured: Change of diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in heart rate during high and low load resistance exercise
Measured as change in heart rate during resistance exercise compared to baseline (pre-exercise)
Measured: Change of heart rate during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in rating of perceived exertion during high and low load resistance exercise
Measured as change of rating of perceived exertion (0-10) during resistance exercise compared to baseline (pre-exercise)
Measured: Change of rating of perceived exertion (score 0-10, 0-no exertion, 10-maximal exertion) during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in Short Physical Performance Battery (SPPB) total score
Measured as change in points of the SPPB after 12 weeks compared to baseline
Measured: Change in the Short Physical Performance battery test total score (0-the worse outcome, 12- the best outcome) after 12 weeks compared to baseline
Change in time of the "Up and Go" test
Measured as change of time (s) in "Up and Go" test
Measured: Change in seconds of the "Up and Go" test after 12 weeks compared to baseline
Change in Grip strength test (kg)
Measured as change of kg in Grip strength test
Measured: Change in kg of Grip strength test after 12 weeks compared to baseline
Change in Arm curl test (number of repetitions)
Measured as change of number of repetitions in Arm curl test
Measured: Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline
Change in time of the Sit to stand test
Measured as change in time (s) of the Sit and stand test
Measured: Change in seconds of the Sit to stand test after 12 weeks compared to baseline
Change in One Leg Heel Raise test (number of repetitions)
Measured as change of number of repetitions in One leg heel raise test
Measured: Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline
Change in total energy expenditure
Measured as change in kcal using accelerometry data
Measured: Change in kcal after 12 weeks compared to baseline
Change in sedentary activity level
Measured as change in minutes spent in sedentary activity level using accelerometry data
Measured: Change in minutes of sedentary activity after 12 weeks compared to baseline
Change in moderate to vigorous physical activity level
Measured as change in minutes spent in moderate to vigorous physical activity level using accelerometry data
Measured: Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline
Change in the Back Scratch test
Measured as change in cm of the Back Scratch test
Measured: Change in cm of the Back Scratch test after 12 weeks compared to baseline
Change in the Chair Sit and Reach test
Measured as change in cm of the Chair Sit and Reach test
Measured: Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline
Change in Stork balance test
Measured as change in seconds of the Stork balance test
Measured: Change in seconds of the Stork balance test after 12 weeks compared to baseline
Change in Short form Health related quality of life questionnaire (SF-12)
Measured as change in score of the SF-12
Measured: Change in score of the Short form 12 items health related questionnaire (12 points -the lowest score, 47 points the highest score) after 12 weeks compared to baseline
Change in Patients health questionnaire score (PHQ-9)
Measured as change in points of PHQ-9 questionnaire
Measured: Change in score of the Patients health 9-item questionnaire (0 points-the best outcome, 27 points-the worse outcome) after 12 weeks compared to baseline
Change in Respiratory Exchange Ratio (RER)
Measured as percent change of RER during cardiopulmonary exercise test
Measured: Change in % after 12 weeks compared to baseline
Change in Ve/VCO2 slope ratio
Measured as change in VE/VCO2 slope
Measured: Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline
Change in Tumor necrosis factor alpha (TNF-alpha) level
Measured as change in TNF-alpha
Measured: Change in TNF-alpha level after 12 weeks compared to baseline
Change in Interleukin 6 (IL-6) level
Measured as change in IL-6 level
Measured: Change in IL-6 level after 12 weeks compared to baseline
Change in Human Growth hormone (hGH) level
Measured as change in hGH level
Measured: Change in hGH level after 12 weeks compared to baseline
Change in Insulin like Growth Factor 1 (IGF-1)
Measured as change in IGF-1 level
Measured: Change in IGF-1 level after 12 weeks compared to baseline
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Measured as change in NT-proBNP level
Measured: Change in NT-proBNP level after 12 weeks compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start23 Nov 2020 (estimated)
- Primary completion30 Jun 2021 (estimated)
- Study completion26 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomisation with three parallel intervention groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- General Hospital Murska Sobota
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, University of Primorska
- Responsible party
- Sponsor
- Investigators
- Mitja Lainščak, MD, PhD, Principal investigator, General Hospital Murska Sobota; University of Ljubljana, Faculty of MedicineTim Kambič, MKin, Principal investigator, General Hospital Murska Sobota; University of Ljubljana, Faculty of Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638764
- Sponsor's protocol ID
- GH-MS-CVD-RT
- Acronym
- RT in CVD
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kambic T, Bozic Mijovski M, Jug B, Hadzic V, Lainscak M. Insulin resistance, lipids and body composition in patients with coronary artery disease after combined aerobic training and resistance training: a randomised, controlled trial. Diabetol Metab Syndr. 2023 Mar 15;15(1):47. doi: 10.1186/s13098-023-01017-w.
PubMed 36918949Kambic T, Sarabon N, Hadzic V, Lainscak M. Physical activity and sedentary behaviour following combined aerobic and resistance training in coronary artery disease patients: A randomised controlled trial. Int J Cardiol. 2023 Jan 1;370:75-79. doi: 10.1016/j.ijcard.2022.10.157. Epub 2022 Oct 29.
PubMed 36367488Kambic T, Sarabon N, Lainscak M, Hadzic V. Combined resistance training with aerobic training improves physical performance in patients with coronary artery disease: A secondary analysis of a randomized controlled clinical trial. Front Cardiovasc Med. 2022 Aug 24;9:909385. doi: 10.3389/fcvm.2022.909385. eCollection 2022.
PubMed 36093154Kambic T, Sarabon N, Hadzic V, Lainscak M. Effects of high-load and low-load resistance training in patients with coronary artery disease: rationale and design of a randomised controlled clinical trial. BMJ Open. 2021 Jul 22;11(7):e051325. doi: 10.1136/bmjopen-2021-051325.
PubMed 34301669Kambic T, Hadzic V, Lainscak M. Hemodynamic Response to High- and Low-Load Resistance Exercise in Patients with Coronary Artery Disease: A Randomized, Crossover Clinical Trial. Int J Environ Res Public Health. 2021 Apr 8;18(8):3905. doi: 10.3390/ijerph18083905.
PubMed 33917770
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT04638764
- Acronym / sponsor ID
- RT in CVD / GH-MS-CVD-RT
- Keywords
- resistance training, coronary artery disease, heart failure, hemodynamic response, cardiac rehabilitation, aerobic training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- General Hospital Murska SobotaUniversity, hospital or other
- Collaborators
- University of Ljubljana, University of Primorska
- Study start
- 23 Nov 2020 (estimated)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 26 Nov 2021 (estimated)
- First posted
- 20 Nov 2020 (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.
In this study coronary artery disease patients and patients with heart failure will be randomly assigned to three training groups: combined aerobic interval training with high intensity resistance training, combined aerobic interval training with low intensity resistance training and aerobic interval training.
Detailed description
Exercise-based cardiac rehabilitation programmes have predominantly used aerobic-dynamic exercise modalities, whereas resistance training have been discouraged in patients with cardiovascular disease, due to safety concerns related to cardiovascular response (heart rate and blood pressure) during the exertion. Contrary to such concerns, recent hemodynamic studies have reported lower blood pressure and heart rate during higher intensity resistance training (>70 % 1-RM) compared to lower intensity resistance training (>40 % 1-RM). Furthermore, the latest meta analysis have demonstrated that combined resistance training with standard aerobic interval training has been superior than aerobic training alone in several aspects of health.
However, there is still huge heterogeneity in training intervention design, also there still lacks studies to further elucidate the effects of high intensity resistance training combined with aerobic training on physical performance (aerobic capacity, muscle strength, balance), body composition, quality of life, morbidity, mortality, etc. Therefore, the aim of this study was to examine the effects of high (70%-80 % 1-RM) versus low loads (30%- 40 % 1-RM) resistance training in combination with aerobic interval cycling (50 % -80% of baseline peak Power output) in coronary artery disease patients and patients with heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Cluster randomisation with three parallel intervention groups
| Arm | Type | Receives |
|---|---|---|
| Aerobic interval training with high loads resistance training | Active comparator | Other: Aerobic interval training combined with high intensity resistance trainingPatient to be randomised into "combined aerobic training with high loads resistance training group". |
| Aerobic interval training with low loads resistance training | Active comparator | Other: Aerobic interval training combined with low intensity resistance trainingPatient to be randomised into "combined aerobic training with low loads resistance training group". |
| Aerobic interval training | Active comparator | Other: Aerobic interval trainingPatient to be randomised into "aerobic training training group". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Stable patients with documented CAD with clinical event (>1 month after acute coronary syndrome and/or percutaneous coronary intervention) or coronarography and/or
- Stable Heart Failure patients with documented reduced ejection fraction (>40-45 %)
- age >18 years
- NYHA class I-III
- Cardiopulmonary exercise test without ECG abnormalities
Key exclusion criteria (8 listed)
- Unstable CHD
- Decompensated HF
- Uncontrolled arrhythmias
- Severe and symptomatic aortic stenosis
- Acute myocarditis, endocarditis, or pericarditis
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 |
|---|---|---|
| Aerobic interval training combined with high intensity resistance trainingAlso: Aerobic and high intensity strength trainingPatients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 70 %- 80 % of one repetition maximum (1-RM)). | Other | Aerobic interval training with high loads resistance training |
| Aerobic interval training combined with low intensity resistance trainingAlso: Aerobic and low intensity strength trainingPatients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 30 %- 40 % 1-RM). | Other | Aerobic interval training with low loads resistance training |
| Aerobic interval trainingAlso: Aerobic trainingPatients enrolled in arm of the study will perform 12 weeks of aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing). | Other | Aerobic interval training |
Primary outcome
Change in Maximal aerobic capacity
Time frame: Change in maximal aerobic capacity at 12 weeks compared to baseline
Measured as change in VO2 max (ml/kg/min)
Change in Maximal voluntary contraction of knee extensors
Time frame: Change in maximal isometric torque at 12 weeks compared to baseline
Measured as change in maximal isometric torque of knee extensors
28 secondary outcomes
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
Time frame: Change in HOMA-IR at 12 weeks compared to baseline
Change in glucose levels
Time frame: Change in glucose levels at 12 weeks compared to baseline
Change in insulin levels
Time frame: Change in insulin levels at 12 weeks compared to baseline
Change in systolic blood pressure during high and low load resistance exercise
Time frame: Change of systolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in diastolic blood pressure during high and low load resistance exercise
Time frame: Change of diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in heart rate during high and low load resistance exercise
Time frame: Change of heart rate during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in rating of perceived exertion during high and low load resistance exercise
Time frame: Change of rating of perceived exertion (score 0-10, 0-no exertion, 10-maximal exertion) during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Change in Short Physical Performance Battery (SPPB) total score
Time frame: Change in the Short Physical Performance battery test total score (0-the worse outcome, 12- the best outcome) after 12 weeks compared to baseline
Change in time of the "Up and Go" test
Time frame: Change in seconds of the "Up and Go" test after 12 weeks compared to baseline
Change in Grip strength test (kg)
Time frame: Change in kg of Grip strength test after 12 weeks compared to baseline
Change in Arm curl test (number of repetitions)
Time frame: Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline
Change in time of the Sit to stand test
Time frame: Change in seconds of the Sit to stand test after 12 weeks compared to baseline
Change in One Leg Heel Raise test (number of repetitions)
Time frame: Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline
Change in total energy expenditure
Time frame: Change in kcal after 12 weeks compared to baseline
Change in sedentary activity level
Time frame: Change in minutes of sedentary activity after 12 weeks compared to baseline
Change in moderate to vigorous physical activity level
Time frame: Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline
Change in the Back Scratch test
Time frame: Change in cm of the Back Scratch test after 12 weeks compared to baseline
Change in the Chair Sit and Reach test
Time frame: Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline
Change in Stork balance test
Time frame: Change in seconds of the Stork balance test after 12 weeks compared to baseline
Change in Short form Health related quality of life questionnaire (SF-12)
Time frame: Change in score of the Short form 12 items health related questionnaire (12 points -the lowest score, 47 points the highest score) after 12 weeks compared to baseline
Change in Patients health questionnaire score (PHQ-9)
Time frame: Change in score of the Patients health 9-item questionnaire (0 points-the best outcome, 27 points-the worse outcome) after 12 weeks compared to baseline
Change in Respiratory Exchange Ratio (RER)
Time frame: Change in % after 12 weeks compared to baseline
Change in Ve/VCO2 slope ratio
Time frame: Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline
Change in Tumor necrosis factor alpha (TNF-alpha) level
Time frame: Change in TNF-alpha level after 12 weeks compared to baseline
Change in Interleukin 6 (IL-6) level
Time frame: Change in IL-6 level after 12 weeks compared to baseline
Change in Human Growth hormone (hGH) level
Time frame: Change in hGH level after 12 weeks compared to baseline
Change in Insulin like Growth Factor 1 (IGF-1)
Time frame: Change in IGF-1 level after 12 weeks compared to baseline
Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
Time frame: Change in NT-proBNP level after 12 weeks compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 36918949Kambic T, Bozic Mijovski M, Jug B, Hadzic V, Lainscak M. Insulin resistance, lipids and body composition in patients with coronary artery disease after combined aerobic training and resistance training: a randomised, controlled trial. Diabetol Metab Syndr. 2023 Mar 15;15(1):47. doi: 10.1186/s13098-023-01017-w.
- Derived from this study: PubMed 36367488Kambic T, Sarabon N, Hadzic V, Lainscak M. Physical activity and sedentary behaviour following combined aerobic and resistance training in coronary artery disease patients: A randomised controlled trial. Int J Cardiol. 2023 Jan 1;370:75-79. doi: 10.1016/j.ijcard.2022.10.157. Epub 2022 Oct 29.
- Derived from this study: PubMed 36093154Kambic T, Sarabon N, Lainscak M, Hadzic V. Combined resistance training with aerobic training improves physical performance in patients with coronary artery disease: A secondary analysis of a randomized controlled clinical trial. Front Cardiovasc Med. 2022 Aug 24;9:909385. doi: 10.3389/fcvm.2022.909385. eCollection 2022.
- Derived from this study: PubMed 34301669Kambic T, Sarabon N, Hadzic V, Lainscak M. Effects of high-load and low-load resistance training in patients with coronary artery disease: rationale and design of a randomised controlled clinical trial. BMJ Open. 2021 Jul 22;11(7):e051325. doi: 10.1136/bmjopen-2021-051325.
- Derived from this study: PubMed 33917770Kambic T, Hadzic V, Lainscak M. Hemodynamic Response to High- and Low-Load Resistance Exercise in Patients with Coronary Artery Disease: A Randomized, Crossover Clinical Trial. Int J Environ Res Public Health. 2021 Apr 8;18(8):3905. doi: 10.3390/ijerph18083905.
- Individual participant dataSharing planned: No
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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.
Tim Kambič, MKin contact
Mitja Lainščak, MD, PhD principal investigator
General Hospital Murska Sobota; University of Ljubljana, Faculty of Medicine
Tim Kambič, MKin principal investigator
General Hospital Murska Sobota; University of Ljubljana, Faculty of Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic interval training combined with high intensity resistance training, Aerobic interval training combined with low intensity resistance training and Aerobic interval training in people with Coronary Artery Disease and Heart Failure With Reduced Ejection Fraction, run by General Hospital Murska Sobota at 1 site in Slovenia.
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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Nov 2020. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mitja Lainščak, MD, PhD (+386 (0)2 5123733, mitja.lainscak@guest.arnes.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal aerobic capacity (time frame: Change in maximal aerobic capacity at 12 weeks compared to baseline). The study lists 2 primary outcomes in all. 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 NCT04638764, which also lists 5 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 20 Nov 2020.