NCT06437145

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 31, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2024

Completed
Last Updated

May 31, 2024

Status Verified

May 1, 2024

Enrollment Period

4 months

First QC Date

April 16, 2024

Last Update Submit

May 25, 2024

Conditions

Keywords

exercise traininghigh intensity interval trainingmoderate intensity continuous trainingheart rate variabilitymyocardial infarction

Outcome Measures

Primary Outcomes (1)

  • HF parameter

    High frequency domain of the HRV

    5-minutes high resolution ECG recording before and after an exercise session

Secondary Outcomes (4)

  • LF parameter

    5-minutes high resolution ECG recording before and after an exercise session

  • SDNN

    5-minutes high resolution ECG recording before and after an exercise session

  • RMSSD

    5-minutes high resolution ECG recording before and after an exercise session

  • pNN50

    5-minutes high resolution ECG recording before and after an exercise session

Other Outcomes (1)

  • Non-linear methods

    5-minutes high resolution ECG recording before and after an exercise session

Study Arms (2)

High intensity interval training (HIIT)

ACTIVE COMPARATOR

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.

Other: Type of Exercise

Moderate intensity continuous training (MICT)

ACTIVE COMPARATOR

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.

Other: Type of Exercise

Interventions

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.

High intensity interval training (HIIT)Moderate intensity continuous training (MICT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • myocardial infarction in last 120 days
  • sinus rhythm

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

Related Publications (3)

  • 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: 20548976BACKGROUND
  • 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: 38578755BACKGROUND
  • 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: 34789148BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Marko Novaković, MD, PhD

    University Medical Centre Ljubljana

    STUDY CHAIR

Central Study Contacts

Marko Novaković, MD, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
HRV parameters analysis will be blinded regarding the exercise training modality.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Each patient will have a bout of HIIT during one session and a bout of MICT during another session performed in a random order.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 16, 2024

First Posted

May 31, 2024

Study Start

February 15, 2024

Primary Completion

June 1, 2024

Study Completion

June 15, 2024

Last Updated

May 31, 2024

Record last verified: 2024-05

Locations