- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07325942
Effectiveness of Low -Versus High -Volume High -Intensity Interval Training in Patients With Chronic Heart Failure
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Aya I Elshenawy
- Phone Number: +01098811085
- Email: dr.aya_ebrahime@yahoo.com
Study Locations
-
-
Giza Governorate
-
Cairo, Giza Governorate, Egypt
- Recruiting
- Cairo University
-
Contact:
- Aya I Elshenawy
- Phone Number: +201098811085
- Email: dr.aya_ebrahime@yahoo.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Chronic stable heart failure patient with reduced ejection fraction (EF <40)
- Age Above 18 years old
- Both males and females
- The ability to provide informed consent
Exclusion Criteria:
Based on the Scientific Statement from the American Heart Association: contraindications for exercise Testing and Training. (Fletcher et al., 2013)
- Acute myocardial infarction (MI), within 2 days
- Ongoing unstable angina
- Uncontrolled cardiac tachy or brady arrhythmia with hemodynamic compromise
- Active endocarditis
- Symptomatic severe aortic stenosis
- Decompensated heart failure
- Acute pulmonary embolism, pulmonary infarction, or deep vein thrombosis
- Acute myocarditis or pericarditis
- Acute aortic dissection
- Physical disability that precludes safe and adequate testing or training
- Known obstructive left main coronary artery stenosis
- Hypertrophic obstructive cardiomyopathy with severe resting gradient
- Recent stroke or transient ischemic attack
- Mental impairment with limited ability to cooperate
- Resting hypertension with systolic or diastolic blood pressures >200/110 mmHg
- Uncorrected medical conditions, such as significant anemia, important electrolyte imbalance, and hyperthyroidism
- Acute decompensated heart failure NYHA class IV
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Low volume high intensity interval training
This group will receive the usual care (standard medical treatment) in addition to LV-HIIT on a treadmill for 8 weeks, 2 sessions per week.
|
Low-volume HIIT (LV-HIIT) is a particularly time-efficient subtype of interval training, which has gained increasing attention in recent years.
As per the previous definition, these brief training protocols typically involve≤10 min of intense exercise within a session lasting≤30 min including warm-up, recovery phases between intervals, and cool-down
standard medical treatment for chronic heart failure as per international guidlines
|
|
Experimental: high volume high intensity interval training
In this group, the patients will receive the usual care (standard treatment) in addition to HV-HIIT on a treadmill for 8 weeks, 2 sessions per week
|
standard medical treatment for chronic heart failure as per international guidlines
long (2-4 min) bouts of high (not maximum) intensity exercise interspersed with recovery periods which have wide varieties in the protocols according to the intensity, duration, and number of intervals performed
|
|
Other: control group
It includes 15 patients who will receive standard medical treatment only
|
standard medical treatment for chronic heart failure as per international guidlines
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6 minute walk test
Time Frame: at enrolment and at the end of treatment at 8 weeks
|
self-paced submaximal field exercise test to assess submaximal functional capacity of the patient , the distance walked by the patient for six minutes will be measured by meters
|
at enrolment and at the end of treatment at 8 weeks
|
|
2D Echocardiographic parameters
Time Frame: at enrollment and at the end of treatment at 8 weeks
|
Left ventricle geometry: left ventricular end-diastolic diameter (LVEDD) mm, left ventricular end-systolic diameter (LVESD) mm, left ventricular end-systolic volume (LVESV) ml. and, left ventricular end-diastolic volume (LVEDV) ml. Left ventricle Systolic function: left ventricular ejection fraction (LVEF) % Left ventricle Diastolic function :E wave cm/s: early diastolic mitral inflow velocity, A wave cm/s: diastolic mitral inflow velocity during late atrial contraction , E/A ratio |
at enrollment and at the end of treatment at 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Minnesota living with heart failure questionnaire (MLHFQ)
Time Frame: at enrollment and at the end of treatment at 8 weeks
|
The Minnesota Living with Heart Failure Questionnaire (MLHFQ) is the tool most widely used and recognized to assess HRQOL in adults with Hf, was developed in 1987 by Thomas Rector, focusing on the underlying relationship between pathophysiology, symptoms, functional limitations, and psychological distress, it measures the impacts of symptoms and treatment on different dimensions of HRQOL in HF patients.
|
at enrollment and at the end of treatment at 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
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
Other Study ID Numbers
- P.T.REC/012/005825
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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