## Protocol Section
### Identification Module
**NCT ID:** NCT02303379

**Brief Title:** Different Endurance Training Protocols in Cardiac Patients

**Official Title:** Effects of Different Endurance Training Protocols on Physical Performance in Cardiac Patients

#### Organization Study ID Info
**ID:** UISM-8
#### Organization
**Class:** OTHER
**Full Name:** Paracelsus Medical University
### Status Module
#### Completion Date
**Date:** 2020-12

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2021-01-29

**Type:** ACTUAL

**Last Update Submit Date:** 2021-01-28

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2018-12

**Type:** ACTUAL

#### Start Date
**Date:** 2014-01

**Status Verified Date:** 2021-01

#### Study First Post Date
**Date:** 2014-11-27
**Type:** ESTIMATED
**Study First Submit Date:** 2014-11-25
**Study First Submit QC Date:** 2014-11-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Paracelsus Medical University

#### Responsible Party

**Investigator Affiliation:** Paracelsus Medical University

**Investigator Full Name:** Prof. Josef Niebauer M.D., Ph.D., MBA

**Investigator Title:** Head of institute

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** It is the aim of our study to compare the effects of 6 and/or 2 years of either HIT (carried out at correctly assessed 85-95% of maximal heart rate), pyramid, or continuous endurance training, on changes of physical exercise capacity in cardiac patients.

**Detailed Description:** The three exercise arms (isocaloric) are composed as follows:

Endurance training: 31 min at 65-75% HRmax, making it a total of 25min; HIT: 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25 min; Pyramid: One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.

All protocols are initiated by 5min of warm-up and end with 5min of cool-down, both at 60-70% HRmax.

Primary Outcome: Individual maximum power output in watt (Pmax). Secondary Outcome: Change of power output in watt at lactate tresholds at 2 and 4mmol/l.

### Conditions Module

**Conditions:**

- Coronary Artery Disease

**Keywords:**

- Training Protocol

- Cardiac Rehabilitation

- High-Intensity Interval Training

- Continuous Training

- Pyramid Training

- Physical Performance

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 52

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Endurance training with constant work load 31min at 65-75% maximal heart rate (HRmax)

**Intervention Names:**

- Other: Pyramid Training

- Other: High-intensity interval training

**Label:** Continuous Endurance training

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.

**Intervention Names:**

- Other: Continuous Endurance Training

- Other: High-intensity interval training

**Label:** Pyramid Training

**Type:** EXPERIMENTAL

#### Arm Group 3

**Description:** HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.

**Intervention Names:**

- Other: Continuous Endurance Training

- Other: Pyramid Training

**Label:** High-intensity intervall training

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- High-intensity intervall training

- Pyramid Training

**Description:** Endurance training with constant work load 31min at 65-75% Hrmax

**Name:** Continuous Endurance Training

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Continuous Endurance training

- High-intensity intervall training

**Description:** One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.

**Name:** Pyramid Training

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Continuous Endurance training

- Pyramid Training

**Description:** HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.

**Name:** High-intensity interval training

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** PWC will be measured by graded exercise testing on cycle ergometer.

**Measure:** Physical work capacity (PWC)

**Time Frame:** 6 weeks or 36 weeks

#### Secondary Outcomes

**Description:** Heart rate will be measured by graded exercise testing on cycle ergometer.

**Measure:** Heart rate

**Time Frame:** 6 weeks or 36 weeks

**Description:** Blood pressure will be measured by graded exercise testing on cycle ergometer.

**Measure:** Blood pressure

**Time Frame:** 6 weeks or 36 weeks

**Description:** Lactate thresholds will be measured by graded exercise testing on cycle ergometer.

**Measure:** Lactate Thresholds

**Time Frame:** 6 weeks or 36 weeks

**Description:** Blood will be taken before and after intervention

**Measure:** Metabolical and cellular blood parameter

**Time Frame:** 6 weeks or 36 weeks

**Description:** BMI will be taken before and after intervention

**Measure:** BMI

**Time Frame:** 6 weeks or 36 weeks

**Description:** Gene expression will be taken before and after intervention

**Measure:** Gene expression

**Time Frame:** 6 weeks or 36 weeks

**Description:** Quality of Life will be taken before and after intervention

**Measure:** Quality of Life

**Time Frame:** 6 weeks or 36 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* acute coronary syndrome (STEMI - NONSTEMI)
* aortocoronary bypass surgery
* percutaneous coronary intervention (PCI)
* state after stable coronary heart disease
* state after heart surgeries
* state after myo-, endo-, or pericarditis
* state after heart- or lung-transplantation
* state after heart failure
* state after pulmonary hypertension
* state after peripheral venous disease
* state after electrophysiological surgery
* state after implantation of an implantable cardioverter or difibrillator
* Patients at high risk
* Patients with cardiac dysrhythmias or sudden death

Exclusion Criteria:

* unstable angina pectoris
* Heart failure (NYHA IV)
* acute myo-, endo-, or pericarditis or other infections
* pulmonary-arterial embolism or phlebothrombosis within 6 months
* hemodynamic instable dysrhythmias
* hypertrophic cardiomyopathy
* medical conditions which prevent patients from complying with the exercise program

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Salzburg

**Country:** Austria

**Facility:** Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

**Zip:** 5020

#### Overall Officials

**Official 1:**

**Affiliation:** Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

**Name:** Prof. Josef Niebauer, M.D, PhD,MBA

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Mayr B, Muller EE, Schafer C, Droese S, Schonfelder M, Niebauer J. Exercise-induced changes in miRNA expression in coronary artery disease. Clin Chem Lab Med. 2021 May 12;59(10):1719-1727. doi: 10.1515/cclm-2021-0164. Print 2021 Sep 27.

**PMID:** 33977686

#### See Also Links

**Label:** Paracelsus Medical University Salzburg, Austria

**URL:** http://www.pmu.ac.at

**Label:** Department of Sports Medicine, Prevention and Rehabilitation Paracelsus Medical University

**URL:** http://www.salk.at/sportmedizin.html

**Label:** Salzburg Regional Hospital

**URL:** http://www.salk.at/

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003327

- Term: Coronary Disease

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M6549

- Name: Coronary Disease

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: HIGH

- As Found: Coronary Artery Disease

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003324

- Term: Coronary Artery Disease

### Misc Info Module

- Version Holder: 2024-05-24
