Heart FailureNCT06647667
High Interval Versus Moderate Intensity Continuous Training on Soluble st2 Biomarkers in Chronic Heart Failure
A study testing HIITS and MICT in people with Heart Failure, run by Cairo University at 1 site in Egypt.
Trial summary
This study was designed to compare between the effect of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) on soluble ST2 biomarkers among chronic heart failure patients, also measure the improvement in the quality of life with different modes of exercise and with of it is more… Read more about this study
- Who is it for?
- Ages 50 to 60 years, men only
- Conditions the study is for
- Heart Failure
- What is being tested?
- HIITS and MICT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2022to 16 Oct 2023
- 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 50 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- The patients selection was according to the following criteria:
- Patients diagnosed with chronic heart failure (New York heart association class I\& II) with systolic left ventricular dysfunction.
- Their left ventricular ejection fraction (LVEF) <40%.
- Medical treatment was optimized at least three months prior to study entry.
- All patients didn't participate in any rehabilitation programs prior to the study.
Who cannot join
- Patients who had met one of the following criteria were excluded from the study:
- Signs of acute heart failure, unstable angina or severe arrhythmia three months prior to enrolment in the study.
- Pacemakers.
- Chronic obstructive pulmonary disease.
- Other disorders counteracting exercise testing conditions that limit lower limb mobility (for example, burns, fractures)
- Pre-existing neuromuscular diseases (for example Myasthenia Gravis).
Trial locations and contacts
1 site in 1 country.
About this study
This study was designed to compare between the effect of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) on soluble ST2 biomarkers among chronic heart failure patients, also measure the improvement in the quality of life with different modes of exercise and with of it is more benifitial for the heart failure patient
Read the detailed description
The data concerned with the study including soluble ST2 biomarker levels, ejection fraction and MLHFQ was measured before and after twelve weeks of treatment.In this study a total sixty male patients with chronic heart failure NYHA class (I \&II) were selected from the outpatient clinic, El-Demerdash hospital, Ain-shams University. Their age ranged from 50-60 years. Patients were randomly assigned into two groups, group A receiving HIIT along with prescribed medical treatment and group B receiving MCT along with prescribed medical treatment.
- Conditions
- Heart Failure
- Being tested
- HIITS, MICT
- Keywords
- sST2 biomarker, Minnesota Questionare, HIITS
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIITSOther
Frequency: HIIT will be in 2 supervised sessions per week for 12 weeks on the treadmill.
session duration from 30-40 min including the waming up and cooling down Intensity: HIIT included 4 minute intervals aiming 60-85% of heart rate reserve
MICTOther
Frequency: Moderate continuous training is scheduled 2 times per week for 12 weeks.
Intensity: exercise had been applied on the treadmill with 40%-59% of heart rate reserve) session duration from 30-40 min including the warming up and cooling down
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | high intensity interval training Receives: Other: HIITS |
| group B | Experimental | moderate intensity continuous training Receives: Other: MICT |
What is being measured
The primary outcome is the main question the study is designed to answer.
soluble ST2 biomarker level
sample was taken at the cubited vein at the beginning of the program and also at its end
Measured: before the start of the trail and at the end of the trail 3 months
Secondary outcomes (3)
ejection fraction
Left ventricular systolic dysfunction was assessed using the ejection fraction by 2D simpson method
Measured: before the start of the trail and at the end of the trail 3 months
mannisota of daily living questionnaire score
The twenty one item questionnaire was usedfrom 0 (none) to 5 (very much). It provides a total score (range 0-105, from best to worst HRQoL), as well as scores for two dimensions, physical (8 items, range 0-40) and emotional (5 items, range 0-25). The other eight items (of the total of 21) are only considered for the calculation of the total score.
Measured: before the start of the trail and at the end of the trail 3 months
peak exercise response
monitoring the peak exercise response
Measured: before the start of the trail and at the end of the trail 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start15 Sep 2022
- Primary completion20 Aug 2023
- Study completion16 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Patients will receive high intensity interval training (HIIT) 2. Patients will receive moderate intensity continuous training (MICT)
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Reda Ali, Cairo University
- Investigators
- Donia M Elmasry, Doctorate, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647667
- Sponsor's protocol ID
- P.T.REC/012/004017
- Status last verified
- Oct 2024
- First submitted
- 14 Jun 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: study protocol and final results
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Interval Versus Moderate Intensity Continuous Training on Soluble st2 Biomarkers in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT06647667
- Acronym / sponsor ID
- P.T.REC/012/004017
- Conditions
- Heart Failure
- Keywords
- sST2 biomarker, Minnesota Questionare, HIITS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 16 Oct 2023 (actual)
- First posted
- 18 Oct 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.
This study was designed to compare between the effect of high intensity interval training (HIIT) and moderate intensity continuous training (MICT) on soluble ST2 biomarkers among chronic heart failure patients, also measure the improvement in the quality of life with different modes of exercise and with of it is more benifitial for the heart failure patient
Detailed description
The data concerned with the study including soluble ST2 biomarker levels, ejection fraction and MLHFQ was measured before and after twelve weeks of treatment.In this study a total sixty male patients with chronic heart failure NYHA class (I \&II) were selected from the outpatient clinic, El-Demerdash hospital, Ain-shams University. Their age ranged from 50-60 years. Patients were randomly assigned into two groups, group A receiving HIIT along with prescribed medical treatment and group B receiving MCT along with prescribed medical treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Patients will receive high intensity interval training (HIIT) 2. Patients will receive moderate intensity continuous training (MICT)
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: HIITShigh intensity interval training |
| group B | Experimental | Other: MICTmoderate intensity continuous training |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The patients selection was according to the following criteria:
Key exclusion criteria (6 listed)
- Patients who had met one of the following criteria were excluded from the study:
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 |
|---|---|---|
| HIITSFrequency: HIIT will be in 2 supervised sessions per week for 12 weeks on the treadmill. session duration from 30-40 min including the waming up and cooling down Intensity: HIIT included 4 minute intervals aiming 60-85% of heart rate reserve | Other | group A |
| MICTFrequency: Moderate continuous training is scheduled 2 times per week for 12 weeks. Intensity: exercise had been applied on the treadmill with 40%-59% of heart rate reserve) session duration from 30-40 min including the warming up and cooling down | Other | group B |
Primary outcome
soluble ST2 biomarker level
Time frame: before the start of the trail and at the end of the trail 3 months
sample was taken at the cubited vein at the beginning of the program and also at its end
3 secondary outcomes
ejection fraction
Time frame: before the start of the trail and at the end of the trail 3 months
mannisota of daily living questionnaire score
Time frame: before the start of the trail and at the end of the trail 3 months
peak exercise response
Time frame: before the start of the trail and at the end of the trail 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: Yes. study protocol and final results
Related trials for Heart Failure
Recruiting
Reducing Fluid Overload in Heart Failure Patients Using a Non-invasive, Renal Independent System
Chronic Heart Failure, CKD Stage 3
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Not yet recruiting
Notification Of High-Risk Veterans for Access to Heart Failure Prevention
Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Recruiting
Achieving Optimal Medical Therapy Through Percutaneous Treatment of Secondary Mitral Regurgitation to Improve Outcome in Patients With HFrEF
Mitral Regurgitation Functional, Heart Failure With Reduced Ejection Fraction (HFrEF)
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.
Donia M Elmasry, Doctorate study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIITS and MICT in people with Heart Failure, run by Cairo University at 1 site in Egypt.
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 5 inclusion and 6 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: finished, as of the sponsor's last update on 18 Oct 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soluble ST2 biomarker level (time frame: before the start of the trail and at the end of the trail 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2024.