ReKoBo: Exercise Training in Individuals With Coronary Artery Disease

Sponsor

University Medical Centre Ljubljana (Other)

Overall Status

Completed

CT.gov ID

NCT03821558

Collaborator

(none)

115

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this controlled trial, patients referred to post-myocardial infarction cardiac rehabilitation will be randomized to either interval or continuous training.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease Myocardial Infarction	Other: Exercise training	N/A

Detailed Description

The trial would i) compare the acute effects of each exercise type on selected cardiovascular indicators; ii) compare the chronic effects of each exercise type on selected cardiovascular indicators; iii) provide information on the association between acute and chronic effects of each exercise type; iv) provide insight into possible mechanisms of effectiveness of each exercise type; v) identify the most safe and effective exercise type for patients with coronary artery disease.

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cardiovascular Rehabilitation in Coronary Artery Disease Patients: Influence of Different Types of Exercise Training on Selected Cardiovascular Parameters

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Interval training group Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak exercise performance) and low-intensity intervals (60-70% of peak exercise performance).	Other: Exercise training Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.
Active Comparator: Continuous training group Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo moderate continuous exercise training at 75% of peak exercise performance.	Other: Exercise training Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.

Arm

Intervention/Treatment

Active Comparator: Interval training group

Patients to be randomized to the 'interval training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo interval exercise series composed of high-intensity intervals (80-90% of peak exercise performance) and low-intensity intervals (60-70% of peak exercise performance).

Other: Exercise training

Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.

Active Comparator: Continuous training group

Patients to be randomized to the 'continuous training group' will have exercise training sessions 3 times per week for a period of 12 weeks. During training, they will undergo moderate continuous exercise training at 75% of peak exercise performance.

Other: Exercise training

Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.

Outcome Measures

Primary Outcome Measures

Change of flow-mediated dilatation of the brachial artery, measured in % [3 months]

Secondary Outcome Measures

Change of the arterial stiffness coefficient [3 months]
Change of maximal oxygen uptake during exercise, measured in ml/kg/min [3 months]
Change of the heart rate variability [3 months]
Change of the heart rate recovery [3 months]
Change in health-related quality of life using SF-36 questionnaire, measured in points [3 months]
It is a self-administered questionnaire comprising 36 items measuring eight dimensions and two subscales (physical and mental)
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels, measured in ng/l [3 months]
Change in osteopontin and D-dimer levels, measured in microg/l [3 months]
Change in selectin and hsCRP, measured in mg/l [3 months]
Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF, measured in ng/l [3 months]
Change in copeptin levels, measured in pmol/l [3 months]
Change in MR-proADM and MR-proANP, measured in nmol/l [3 months]
Change in homoarginine, ADMA and SDMA levels, measured in micromol/l [3 months]
Change in fibrinogen and Lp(a) levels, measured in mg/dl [3 months]
Change in insuline level, measure in microIU/ml [3 months]
Change in total cholesterol, LDL, HDL, triglycerides and glucose levels, measured in mmol/l [3 months]
Change in overall haemostatic potential [3 months]

Other Outcome Measures

Change in the flow-mediated dilation during single exercise training session, measured in % [3 months]
Change in IL-6, IL-8, IL-10, TNF-alpha and NT-proBNP levels during single exercise training session, measured in ng/l [3 months]
Change in selectin and hsCRP during single exercise training session, measured in mg/l [3 months]
Change in hsTnI, CK MB, endocan, sST2, galectin-3, NGAL, CD40 ligand and BDNF levels during single exercise training session, measured in ng/l [3 months]
Change in copeptin levels during single exercise training session, measured in pmol/l [3 months]
Change in homoarginine, ADMA and SDMA levels during single exercise training session, measured in micromol/l [3 months]
Change in fibrinogen level during single exercise training session, measured in mg/dl [3 months]
Change in insuline levels during single exercise training session, measure in microIU/ml [3 months]
Change in osteopontin and D-dimer levels during single exercise training session, measured in microg/l [3 months]
Change in overall haemostatic potential during single exercise training session [3 months]