Myocardial InfarctionMW2acuteNCT06437145
Acute Effects of HIIT vs. MICT on HRV
A study testing Type of Exercise in people with Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Type of Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- 15 Feb 2024to 15 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- myocardial infarction in last 120 days
- sinus rhythm
Who cannot join
- contraindications for exercise training
- uncontrolled dysrhythmias
- Heart Failure NYHA IV stage
- cognitive impairment
- pregnancy
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Marko Novaković, MD, PhD, 0038615228032, marko.novakovic@kclj.si
About this study
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
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
- Myocardial Infarction
- Being tested
- Type of Exercise
- Keywords
- exercise training, high intensity interval training, moderate intensity continuous training, heart rate variability, myocardial infarction
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Type of ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Type of Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
HF parameter
High frequency domain of the HRV
Measured: 5-minutes high resolution ECG recording before and after an exercise session
Secondary outcomes (4)
LF parameter
Low frequency domain of the HRV
Measured: 5-minutes high resolution ECG recording before and after an exercise session
SDNN
Standard deviation of NN intervals
Measured: 5-minutes high resolution ECG recording before and after an exercise session
RMSSD
Root mean square of successive RR interval differences
Measured: 5-minutes high resolution ECG recording before and after an exercise session
pNN50
Percentage of successive RR intervals that differ by more than 50 ms
Measured: 5-minutes high resolution ECG recording before and after an exercise session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start15 Feb 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Borut Jug, University Medical Centre Ljubljana
- Investigators
- Marko Novaković, MD, PhD, Study chair, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437145
- Sponsor's protocol ID
- UKCLRehab2024/1
- Acronym
- MW2acute
- Status last verified
- May 2024
- First submitted
- 16 Apr 2024
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 20548976El-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.
PubMed 38578755Grassler 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.
PubMed 34789148
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06437145
- Acronym / sponsor ID
- MW2acute / UKCLRehab2024/1
- Conditions
- Myocardial Infarction
- Keywords
- exercise training, high intensity interval training, moderate intensity continuous training, heart rate variability, myocardial infarction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| High intensity interval training (HIIT) | Active comparator | Other: Type of ExerciseThe 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. |
| Moderate intensity continuous training (MICT) | Active comparator | Other: Type of ExerciseThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- myocardial infarction in last 120 days
- sinus rhythm
Key exclusion criteria (5 listed)
- contraindications for exercise training
- uncontrolled dysrhythmias
- Heart Failure NYHA IV stage
- cognitive impairment
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Type of ExerciseThe 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. | Other | High intensity interval training (HIIT), Moderate intensity continuous training (MICT) |
Primary outcome
HF parameter
Time frame: 5-minutes high resolution ECG recording before and after an exercise session
High frequency domain of the HRV
4 secondary outcomes
LF parameter
Time frame: 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
RMSSD
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Background: PubMed 20548976Routledge 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.
- Background: PubMed 38578755El-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.
- Background: PubMed 34789148Grassler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marko Novaković, MD, PhD study chair
University Medical Centre Ljubljana
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Type of Exercise in people with Myocardial Infarction, run by University Medical Centre Ljubljana at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marko Novaković, MD, PhD (0038615228032, marko.novakovic@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HF parameter (time frame: 5-minutes high resolution ECG recording before and after an exercise session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06437145, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.