Resistance Training in Cardiovascular Disease Patients

Coronary Artery Disease Clinical Trial

— RT in CVD  

Official title:

Resistance Training in Coronary Artery Disease and Heart Failure Patients Undergoing Cardiac Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04638764
• Other study ID #: GH-MS-CVD-RT
• Status: Recruiting
• Phase: N/A
• Start date: November 23, 2020
• Est. completion date: November 26, 2021

Study information

• Verified date: November 2020
• Source: General Hospital Murska Sobota
• Contact: Mitja Lainšcak, MD, PhD
• Phone: +386 (0)2 5123733
• Email: mitja.lainscak[@]guest.arnes.si
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: November 26, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Myocardial Ischemia

Intervention

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)).
• 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).
• 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).

Locations

Country	Name	City	State
Slovenia	Division of Cardiology, General Hospital Murska Sobota	Murska Sobota

Sponsors (3)

Lead Sponsor	Collaborator
General Hospital Murska Sobota	University of Ljubljana, Faculty of Sport, University of Primorska

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maximal aerobic capacity	Measured as change in VO2 max (ml/kg/min)	Change in maximal aerobic capacity at 12 weeks compared to baseline
Primary	Change in Maximal voluntary contraction of knee extensors	Measured as change in maximal isometric torque of knee extensors	Change in maximal isometric torque at 12 weeks compared to baseline
Secondary	Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)	Measured as change in HOMA IR (%)	Change in HOMA-IR at 12 weeks compared to baseline
Secondary	Change in glucose levels	Measured as change in glucose levels (mmol/L)	Change in glucose levels at 12 weeks compared to baseline
Secondary	Change in insulin levels	Measured as change in insulin levels	Change in insulin levels at 12 weeks compared to baseline
Secondary	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	Change of systolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Secondary	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)	Change of diastolic blood pressure during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Secondary	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)	Change of heart rate during resistance exercise compared to baseline (pre-exercise) within the first and the last week of the intervention
Secondary	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)	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
Secondary	Change in Short Physical Performance Battery (SPPB) total score	Measured as change in points of the SPPB after 12 weeks compared to baseline	Change in the Short Physical Performance battery test total score (0-the worse outcome, 12- the best outcome) after 12 weeks compared to baseline
Secondary	Change in time of the "Up and Go" test	Measured as change of time (s) in "Up and Go" test	Change in seconds of the "Up and Go" test after 12 weeks compared to baseline
Secondary	Change in Grip strength test (kg)	Measured as change of kg in Grip strength test	Change in kg of Grip strength test after 12 weeks compared to baseline
Secondary	Change in Arm curl test (number of repetitions)	Measured as change of number of repetitions in Arm curl test	Change in number of repetitions of the Arm curl test after 12 weeks compared to baseline
Secondary	Change in time of the Sit to stand test	Measured as change in time (s) of the Sit and stand test	Change in seconds of the Sit to stand test after 12 weeks compared to baseline
Secondary	Change in One Leg Heel Raise test (number of repetitions)	Measured as change of number of repetitions in One leg heel raise test	Change in number of repetitions of One leg heel raise test after 12 weeks compared to baseline
Secondary	Change in total energy expenditure	Measured as change in kcal using accelerometry data	Change in kcal after 12 weeks compared to baseline
Secondary	Change in sedentary activity level	Measured as change in minutes spent in sedentary activity level using accelerometry data	Change in minutes of sedentary activity after 12 weeks compared to baseline
Secondary	Change in moderate to vigorous physical activity level	Measured as change in minutes spent in moderate to vigorous physical activity level using accelerometry data	Change in minutes of moderate to vigorous physical activity after 12 weeks compared to baseline
Secondary	Change in the Back Scratch test	Measured as change in cm of the Back Scratch test	Change in cm of the Back Scratch test after 12 weeks compared to baseline
Secondary	Change in the Chair Sit and Reach test	Measured as change in cm of the Chair Sit and Reach test	Change in cm of the Chair sit and Reach test after 12 weeks compared to baseline
Secondary	Change in Stork balance test	Measured as change in seconds of the Stork balance test	Change in seconds of the Stork balance test after 12 weeks compared to baseline
Secondary	Change in Short form Health related quality of life questionnaire (SF-12)	Measured as change in score of the SF-12	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
Secondary	Change in Patients health questionnaire score (PHQ-9)	Measured as change in points of PHQ-9 questionnaire	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
Secondary	Change in Respiratory Exchange Ratio (RER)	Measured as percent change of RER during cardiopulmonary exercise test	Change in % after 12 weeks compared to baseline
Secondary	Change in Ve/VCO2 slope ratio	Measured as change in VE/VCO2 slope	Change in ratio of VE/VCO2 slope after 12 weeks compared to baseline
Secondary	Change in Tumor necrosis factor alpha (TNF-alpha) level	Measured as change in TNF-alpha	Change in TNF-alpha level after 12 weeks compared to baseline
Secondary	Change in Interleukin 6 (IL-6) level	Measured as change in IL-6 level	Change in IL-6 level after 12 weeks compared to baseline
Secondary	Change in Human Growth hormone (hGH) level	Measured as change in hGH level	Change in hGH level after 12 weeks compared to baseline
Secondary	Change in Insulin like Growth Factor 1 (IGF-1)	Measured as change in IGF-1 level	Change in IGF-1 level after 12 weeks compared to baseline
Secondary	Change in N-terminal-pro brain natriuretic peptide (NT-proBNP)	Measured as change in NT-proBNP level	Change in NT-proBNP level after 12 weeks compared to baseline