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Resistance Training in Cardiovascular Disease Patients (RT in CVD)

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ClinicalTrials.gov Identifier: NCT04638764
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Collaborators:
University of Ljubljana
University of Primorska
Information provided by (Responsible Party):
General Hospital Murska Sobota

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Heart Failure With Reduced Ejection Fraction Other: Aerobic interval training combined with high intensity resistance training Other: Aerobic interval training combined with low intensity resistance training Other: Aerobic interval training Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomisation with three parallel intervention groups
Masking: None (Open Label)
Masking Description: Baseline and post-training measurement will be performed by experienced research nurse and physiotherapist, which will not participate in intervention.
Primary Purpose: Treatment
Official Title: Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation
Estimated Study Start Date : November 23, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : November 26, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Aerobic interval training with high loads resistance training
Patient to be randomised into "combined aerobic training with high loads resistance training group".
Other: Aerobic interval training combined with high intensity resistance 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)).
Other Name: Aerobic and high intensity strength training

Active Comparator: Aerobic interval training with low loads resistance training
Patient to be randomised into "combined aerobic training with low loads resistance training group".
Other: Aerobic interval training combined with low intensity resistance 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).
Other Name: Aerobic and low intensity strength training

Active Comparator: Aerobic interval training
Patient to be randomised into "aerobic training training group".
Other: Aerobic interval 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).
Other Name: Aerobic training




Primary Outcome Measures :
  1. 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)

  2. 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


Secondary Outcome Measures :
  1. Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) [ Time Frame: Change in HOMA-IR at 12 weeks compared to baseline ]
    Measured as change in HOMA IR (%)

  2. Change in glucose levels [ Time Frame: Change in glucose levels at 12 weeks compared to baseline ]
    Measured as change in glucose levels (mmol/L)

  3. Change in insulin levels [ Time Frame: Change in insulin levels at 12 weeks compared to baseline ]
    Measured as change in insulin levels

  4. 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 ]
    Measured as change in systolic blood pressure during resistance exercise compared to baseline (pre-exercise) values

  5. 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 ]
    Measured as change in diastolic blood pressure during resistance exercise compared to baseline (pre-exercise)

  6. 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 ]
    Measured as change in heart rate during resistance exercise compared to baseline (pre-exercise)

  7. 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 ]
    Measured as change of rating of perceived exertion (0-10) during resistance exercise compared to baseline (pre-exercise)

  8. 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 ]
    Measured as change in points of the SPPB after 12 weeks compared to baseline

  9. 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 ]
    Measured as change of time (s) in "Up and Go" test

  10. Change in Grip strength test (kg) [ Time Frame: Change in kg of Grip strength test after 12 weeks compared to baseline ]
    Measured as change of kg in Grip strength test

  11. 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 ]
    Measured as change of number of repetitions in Arm curl test

  12. 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 ]
    Measured as change in time (s) of the Sit and stand test

  13. 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 ]
    Measured as change of number of repetitions in One leg heel raise test

  14. Change in total energy expenditure [ Time Frame: Change in kcal after 12 weeks compared to baseline ]
    Measured as change in kcal using accelerometry data

  15. Change in sedentary activity level [ Time Frame: Change in minutes of sedentary activity after 12 weeks compared to baseline ]
    Measured as change in minutes spent in sedentary activity level using accelerometry data

  16. 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 ]
    Measured as change in minutes spent in moderate to vigorous physical activity level using accelerometry data

  17. Change in the Back Scratch test [ Time Frame: Change in cm of the Back Scratch test after 12 weeks compared to baseline ]
    Measured as change in cm of the Back Scratch test

  18. 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 ]
    Measured as change in cm of the Chair Sit and Reach test

  19. Change in Stork balance test [ Time Frame: Change in seconds of the Stork balance test after 12 weeks compared to baseline ]
    Measured as change in seconds of the Stork balance test

  20. 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 ]
    Measured as change in score of the SF-12

  21. 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 ]
    Measured as change in points of PHQ-9 questionnaire

  22. Change in Respiratory Exchange Ratio (RER) [ Time Frame: Change in % after 12 weeks compared to baseline ]
    Measured as percent change of RER during cardiopulmonary exercise test

  23. Change in Ve/VCO2 slope ratio [ Time Frame: Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline ]
    Measured as change in VE/VCO2 slope

  24. Change in Tumor necrosis factor alpha (TNF-alpha) level [ Time Frame: Change in TNF-alpha level after 12 weeks compared to baseline ]
    Measured as change in TNF-alpha

  25. Change in Interleukin 6 (IL-6) level [ Time Frame: Change in IL-6 level after 12 weeks compared to baseline ]
    Measured as change in IL-6 level

  26. Change in Human Growth hormone (hGH) level [ Time Frame: Change in hGH level after 12 weeks compared to baseline ]
    Measured as change in hGH level

  27. Change in Insulin like Growth Factor 1 (IGF-1) [ Time Frame: Change in IGF-1 level after 12 weeks compared to baseline ]
    Measured as change in IGF-1 level

  28. Change in N-terminal-pro brain natriuretic peptide (NT-proBNP) [ Time Frame: Change in NT-proBNP level after 12 weeks compared to baseline ]
    Measured as change in NT-proBNP level



Information from the National Library of Medicine

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

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Unstable CHD
  • Decompensated HF
  • Uncontrolled arrhythmias
  • Severe and symptomatic aortic stenosis
  • Acute myocarditis, endocarditis, or pericarditis
  • Aortic dissection
  • Marfan syndrome
  • Musculoskeletal limitations

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): NCT04638764


Contacts
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Contact: Mitja Lainščak, MD, PhD +386 (0)2 5123733 mitja.lainscak@guest.arnes.si
Contact: Tim Kambič, MKin tim.kambic@gmail.com

Locations
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Slovenia
Division of Cardiology, General Hospital Murska Sobota Recruiting
Murska Sobota, Slovenia, 9000
Contact: Mitja Lainščak, MD, PhD       mitja.lainscak@guest.arnes.si   
Contact: Tim Kambič, MKin       tim.kambic@gmail.com   
Principal Investigator: Tim Kambič, MKin         
Principal Investigator: Mitja Lainščak, MD, PhD         
Sub-Investigator: Vedran Hadžić, MD, PhD         
Sub-Investigator: Jerneja Farkaš Lainščak, MD, PhD         
Sub-Investigator: Nejc Šarabon, PhD         
Sponsors and Collaborators
General Hospital Murska Sobota
University of Ljubljana
University of Primorska
Investigators
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Principal Investigator: Mitja Lainščak, MD, PhD General Hospital Murska Sobota; University of Ljubljana, Faculty of Medicine
Principal Investigator: Tim Kambič, MKin General Hospital Murska Sobota; University of Ljubljana, Faculty of Sport
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: General Hospital Murska Sobota
ClinicalTrials.gov Identifier: NCT04638764    
Other Study ID Numbers: GH-MS-CVD-RT
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by General Hospital Murska Sobota:
resistance training
coronary artery disease
heart failure
hemodynamic response
cardiac rehabilitation
aerobic training
Additional relevant MeSH terms:
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Heart Failure
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases