- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06437145
Acute Effects of HIIT vs. MICT on HRV (MW2acute)
Acute Effects of High Intensity Interval Training (HIIT) vs. Moderate Intensity Continuous Training (MICT) on Heart Rate Variability Parameters in Patients After Myocardial Infarction
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.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Marko Novaković, MD, PhD
- Phone Number: 0038615228032
- Email: marko.novakovic@kclj.si
Study Locations
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-
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Ljubljana, Slovenia, 1000
- Recruiting
- University Medical Centre Ljubljana
-
Contact:
- Marko Novaković, MD, PhD
- Phone Number: 0038615228032
- Email: marko.novakovic@kclj.si
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: High intensity interval training (HIIT)
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 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.
|
|
Active Comparator: Moderate intensity continuous training (MICT)
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
HF parameter
Time Frame: 5-minutes high resolution ECG recording before and after an exercise session
|
High frequency domain of the HRV
|
5-minutes high resolution ECG recording before and after an exercise session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LF parameter
Time Frame: 5-minutes high resolution ECG recording before and after an exercise session
|
Low frequency domain of the HRV
|
5-minutes high resolution ECG recording before and after an exercise session
|
|
SDNN
Time Frame: 5-minutes high resolution ECG recording before and after an exercise session
|
Standard deviation of NN intervals
|
5-minutes high resolution ECG recording before and after an exercise session
|
|
RMSSD
Time Frame: 5-minutes high resolution ECG recording before and after an exercise session
|
Root mean square of successive RR interval differences
|
5-minutes high resolution ECG recording before and after an exercise session
|
|
pNN50
Time Frame: 5-minutes high resolution ECG recording before and after an exercise session
|
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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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Non-linear methods
Time Frame: 5-minutes high resolution ECG recording before and after an exercise session
|
SD1, SD2
|
5-minutes high resolution ECG recording before and after an exercise session
|
Collaborators and Investigators
Investigators
- Study Chair: Marko Novaković, MD, PhD, University Medical Centre Ljubljana
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKCLRehab2024/1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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