## Protocol Section
### Identification Module
**NCT ID:** NCT06437145

**Acronym:** MW2acute

**Brief Title:** Acute Effects of HIIT vs. MICT on HRV

**Official Title:** Acute Effects of High Intensity Interval Training (HIIT) vs. Moderate Intensity Continuous Training (MICT) on Heart Rate Variability Parameters in Patients After Myocardial Infarction

#### Organization Study ID Info
**ID:** UKCLRehab2024/1
#### Organization
**Class:** OTHER
**Full Name:** University Medical Centre Ljubljana
### Status Module
#### Completion Date
**Date:** 2024-06-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-25

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-02-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-04-16
**Study First Submit QC Date:** 2024-05-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University Medical Centre Ljubljana

#### Responsible Party

**Investigator Affiliation:** University Medical Centre Ljubljana

**Investigator Full Name:** Borut Jug

**Investigator Title:** Prof.

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** Heart rate variability (HRV) is impaired in patients after myocardial infarction. Most studies so far have proved chronic beneficial effects of different types of exercise on HRV parameters. Data on acute effects of different types of exercise training (e.g. high intensity interval training \[HIIT\] and moderate intensity continuous training \[MICT\]) is scarce.

Patients in the study will perform both HIIT and MICT in a random order and in-between break of at least 48 hours. A 5-minute high resolution ECG recording will be performed before and immediately after both HIIT and MICT.

### Conditions Module

**Conditions:**

- Myocardial Infarction

**Keywords:**

- exercise training

- high intensity interval training

- moderate intensity continuous training

- heart rate variability

- myocardial infarction

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

**Intervention Model Description:** Each patient will have a bout of HIIT during one session and a bout of MICT during another session performed in a random order.

##### Masking Info

**Masking:** SINGLE

**Masking Description:** HRV parameters analysis will be blinded regarding the exercise training modality.

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 20

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The high-intensity interval training session consists of 5-min warm-up and 5-min cool-down periods. The main part has 7 cycles. Each cycle consists of 1.5 min of 80-90% of HRpeak and 3 min of 65-70% of HRpeak.

**Intervention Names:**

- Other: Type of Exercise

**Label:** High intensity interval training (HIIT)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** The moderate-intensity continuous training session consists of 5 min warm-up and 3-min cool down period. The main part consists of 32 min of 75% of HRpeak.

**Intervention Names:**

- Other: Type of Exercise

**Label:** Moderate intensity continuous training (MICT)

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- High intensity interval training (HIIT)

- Moderate intensity continuous training (MICT)

**Description:** The high-intensity interval training session consists of 5-min warm-up and 5-min cool-down periods. The main part has 7 cycles. Each cycle consists of 1.5 min of 80-90% of HRpeak and 3 min of 65-70% of HRpeak. The moderate-intensity continuous training session consists of 5 min warm-up and 3-min cool down period. The main part consists of 32 min of 75% of HRpeak.

**Name:** Type of Exercise

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** SD1, SD2

**Measure:** Non-linear methods

**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session

#### Primary Outcomes

**Description:** High frequency domain of the HRV

**Measure:** HF parameter

**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session

#### Secondary Outcomes

**Description:** Low frequency domain of the HRV

**Measure:** LF parameter

**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session

**Description:** Standard deviation of NN intervals

**Measure:** SDNN

**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session

**Description:** Root mean square of successive RR interval differences

**Measure:** RMSSD

**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session

**Description:** Percentage of successive RR intervals that differ by more than 50 ms

**Measure:** pNN50

**Time Frame:** 5-minutes high resolution ECG recording before and after an exercise session

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* myocardial infarction in last 120 days
* sinus rhythm

Exclusion Criteria:

* contraindications for exercise training
* uncontrolled dysrhythmias
* Heart Failure NYHA IV stage
* cognitive impairment
* pregnancy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** marko.novakovic@kclj.si

**Name:** Marko Novaković, MD, PhD

**Phone:** 0038615228032

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Ljubljana

**Contacts:**

***Contact 1:***

- **Email:** marko.novakovic@kclj.si

- **Name:** Marko Novaković, MD, PhD

- **Phone:** 0038615228032

- **Role:** CONTACT

**Country:** Slovenia

**Facility:** University Medical Centre Ljubljana

**Status:** RECRUITING

**Zip:** 1000

#### Overall Officials

**Official 1:**

**Affiliation:** University Medical Centre Ljubljana

**Name:** Marko Novaković, MD, PhD

**Role:** STUDY_CHAIR

### References Module

#### References

**Citation:** Routledge FS, Campbell TS, McFetridge-Durdle JA, Bacon SL. Improvements in heart rate variability with exercise therapy. Can J Cardiol. 2010 Jun-Jul;26(6):303-12. doi: 10.1016/s0828-282x(10)70395-0.

**PMID:** 20548976

**Citation:** El-Malahi O, Mohajeri D, Mincu R, Bauerle A, Rothenaicher K, Knuschke R, Rammos C, Rassaf T, Lortz J. Beneficial impacts of physical activity on heart rate variability: A systematic review and meta-analysis. PLoS One. 2024 Apr 5;19(4):e0299793. doi: 10.1371/journal.pone.0299793. eCollection 2024.

**PMID:** 38578755

**Citation:** Grassler B, Thielmann B, Bockelmann I, Hokelmann A. Effects of different exercise interventions on heart rate variability and cardiovascular health factors in older adults: a systematic review. Eur Rev Aging Phys Act. 2021 Nov 17;18(1):24. doi: 10.1186/s11556-021-00278-6.

**PMID:** 34789148

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000014652

- Term: Vascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12155

- Name: Myocardial Infarction

- Relevance: HIGH

- As Found: Myocardial Infarction

- ID: M10282

- Name: Infarction

- Relevance: HIGH

- As Found: Infarction

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000007238

- Term: Infarction

### Misc Info Module

- Version Holder: 2024-05-31
