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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06437145
Other study ID # UKCLRehab2024/1
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 15, 2024
Est. completion date June 15, 2024

Study information

Verified date May 2024
Source University Medical Centre Ljubljana
Contact Marko Novakovic, MD, PhD
Phone 0038615228032
Email marko.novakovic@kclj.si
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date June 15, 2024
Est. primary completion date June 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Type of Exercise
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.

Locations

Country Name City State
Slovenia University Medical Centre Ljubljana Ljubljana

Sponsors (1)

Lead Sponsor Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Non-linear methods SD1, SD2 5-minutes high resolution ECG recording before and after an exercise session
Primary HF parameter High frequency domain of the HRV 5-minutes high resolution ECG recording before and after an exercise session
Secondary LF parameter Low frequency domain of the HRV 5-minutes high resolution ECG recording before and after an exercise session
Secondary SDNN Standard deviation of NN intervals 5-minutes high resolution ECG recording before and after an exercise session
Secondary RMSSD Root mean square of successive RR interval differences 5-minutes high resolution ECG recording before and after an exercise session
Secondary pNN50 Percentage of successive RR intervals that differ by more than 50 ms 5-minutes high resolution ECG recording before and after an exercise session
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