Clinical trial NCT04638764: Resistance Training in Cardiovascular Disease Patients
Official title: Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Heart Failure With Reduced Ejection Fraction
Keywords: resistance training
coronary artery disease
heart failure
hemodynamic response
cardiac rehabilitation
aerobic training
Lead sponsor: General Hospital Murska Sobota
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
name: University of Primorska
First posted: 2020-11-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomisation with three parallel intervention groups
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Maximal aerobic capacity
timeFrame: Change in maximal aerobic capacity at 12 weeks compared to baseline
measure: Change in Maximal voluntary contraction of knee extensors
timeFrame: Change in maximal isometric torque at 12 weeks compared to baseline
Secondary outcomes:
measure: Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
timeFrame: Change in HOMA-IR at 12 weeks compared to baseline
measure: Change in glucose levels
timeFrame: Change in glucose levels at 12 weeks compared to baseline
measure: Change in insulin levels
timeFrame: Change in insulin levels at 12 weeks compared to baseline
measure: Change in systolic blood pressure during high and low load resistance exercise
timeFrame: Change of systolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
measure: Change in diastolic blood pressure during high and low load resistance exercise
timeFrame: Change of diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
measure: Change in heart rate during high and low load resistance exercise
timeFrame: Change of heart rate during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
measure: Change in rating of perceived exertion during high and low load resistance exercise
timeFrame: 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
measure: Change in Short Physical Performance Battery (SPPB) total score
timeFrame: Change in the Short Physical Performance battery test total score (0-the worse outcome, 12- the best outcome) after 12 weeks compared to baseline
measure: Change in time of the "Up and Go" test
timeFrame: Change in seconds of the "Up and Go" test after 12 weeks compared to baseline
measure: Change in Grip strength test (kg)
timeFrame: Change in kg of Grip strength test after 12 weeks compared to baseline
measure: Change in Arm curl test (number of repetitions)
timeFrame: Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline
measure: Change in time of the Sit to stand test
timeFrame: Change in seconds of the Sit to stand test after 12 weeks compared to baseline
measure: Change in One Leg Heel Raise test (number of repetitions)
timeFrame: Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline
measure: Change in total energy expenditure
timeFrame: Change in kcal after 12 weeks compared to baseline
measure: Change in sedentary activity level
timeFrame: Change in minutes of sedentary activity after 12 weeks compared to baseline
measure: Change in moderate to vigorous physical activity level
timeFrame: Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline
measure: Change in the Back Scratch test
timeFrame: Change in cm of the Back Scratch test after 12 weeks compared to baseline
measure: Change in the Chair Sit and Reach test
timeFrame: Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline
measure: Change in Stork balance test
timeFrame: Change in seconds of the Stork balance test after 12 weeks compared to baseline
measure: Change in Short form Health related quality of life questionnaire (SF-12)
timeFrame: 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
measure: Change in Patients health questionnaire score (PHQ-9)
timeFrame: 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
measure: Change in Respiratory Exchange Ratio (RER)
timeFrame: Change in % after 12 weeks compared to baseline
measure: Change in Ve/VCO2 slope ratio
timeFrame: Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline
measure: Change in Tumor necrosis factor alpha (TNF-alpha) level
timeFrame: Change in TNF-alpha level after 12 weeks compared to baseline
measure: Change in Interleukin 6 (IL-6) level
timeFrame: Change in IL-6 level after 12 weeks compared to baseline
measure: Change in Human Growth hormone (hGH) level
timeFrame: Change in hGH level after 12 weeks compared to baseline
measure: Change in Insulin like Growth Factor 1 (IGF-1)
timeFrame: Change in IGF-1 level after 12 weeks compared to baseline
measure: Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)
timeFrame: Change in NT-proBNP level after 12 weeks compared to baseline
Other outcomes:
Locations:
city: Murska Sobota
country: Slovenia
facility: Division of Cardiology, General Hospital Murska Sobota
Study officials:
affiliation: General Hospital Murska Sobota; University of Ljubljana, Faculty of Medicine
name: Mitja Lainščak, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital Murska Sobota; University of Ljubljana, Faculty of Sport
name: Tim Kambič, MKin
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kambic 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.
citation: Kambic 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.
citation: Kambic 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.
citation: Kambic 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.