Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201710002716276 Date of Approval: 22/10/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title High Intensity Interval Training Versus Continuous Training on Ventricular Remodeling in Chronic Heart Failure Patients.
Official scientific title effect of High Intensity Interval Training Versus Continuous Training on Ventricular Remodeling in Chronic Heart Failure Patients.
Brief summary describing the background and objectives of the trial It was founded that aerobic interval training is superior to moderate continuous training in patients with post infarction heart failure with regard to reversal of left ventricular remodeling, aerobic capacity, endothelial function, and quality of life).however, there is still controversy concerning the intensity and formate of exercise that has the optimal valuable effects, further studies should therefore focus on finding the optimal exercise protocol for those patients to achieve long-term benefits and adherence.the current study This study will be conducted to compare between the effect of high intensity interval training versus moderate continuous training on left ventricular remolding, bioavailability of the vascular endothelium, and quality of life in chronic heart failure patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Chronic Heart Failure
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 23/10/2017
Actual trial start date 23/10/2017
Anticipated date of last follow up 05/01/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation (please state block size and whether or not the block size was variable) Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group high intensity interval training 3 times weekly 12 weeks Mode of exercise will be Cycling using bicycle ergometer for lower limb Intensity of exercise will be 1min interval at high intensity 90 to 95%of peak heart rate separated by 4 min active pause at 50 to 70 %of peak heart rate. Duration will be 40 min session (5min warming up -30min conditioning phase and 5 min cooling down) 15
Experimental Group continuous moderate intensity 3 times weekly 12 weeks Mode of exercise will be bicycle ergometer for lower limb. Intensity of exercise will be 30 min of moderate intensity aerobic training at 60 to 75% of maximum heart rate. Duration: will be 40 min session (5min warming up -30min conditioning phase and 5 min cooling down) 15
Control Group control group 12 weeks the patients were instructed to maintain their usual physical activity level 15 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients with ischemic heart failure -Fractional shortening < 25% and ejection fraction < 40% - Sinus rhythm -New York Heart Association (NYHA) class II-III. -Patients should be on optimal medical treatment. -Body mass index between 25 -29.9. o Chronic heart failure due to other causes o Atrial fibrillation (until resolved) o Sever valvular dysfunction o History of pulmonary disease (chronic obstructive lung disease, moderate to severe pulmonary hypertension). o Recent acute coronary syndrome or revascularization (3months). o Active inflammatory disease including peri or myocardities. o Exercise limited by angina or peripheral arterial occlusive disease o Cerebrovascular or musculoskeletal disease preventing exercise testing or training. o Poorly controlled or exercise-induced cardiac arrhythmias o Logistic problems to attend regular exercise training sessions o Uncontrolled hypertension o Uncontrolled diabetes. 50 Year(s) 60 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/09/2016 ethical committee, Faculty of physical therapy, Cairo University.
Ethics Committee Address
Street address City Postal code Country
ahmad elzayyat street, ben elsarayat Giza Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 04/09/2016 ethics committe , faculty of physical therapy, cairo university, egypt
Ethics Committee Address
Street address City Postal code Country
ahmad elzayyat street Giza Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome left ventricular internal dimensions pre study period( 12 weeks) post study period (12 weeks)
Secondary Outcome ejection fraction pre study period( 12 weeks) post study period (12 weeks)
Secondary Outcome fractional shortening pre study period post study period
Secondary Outcome brachial flow mediated dilation pre study period post study period
Secondary Outcome ¿ Minnesota Living With Heart Failure Questionnaire pre study period post study period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
national heart institute embaba Giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
National heart institute embaba Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of physical therapy, cairo university ahmad elzayyat street , ben elsarayat Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
basant hamdy el-refaey elmesaha elharam Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator basant elrefaey bassanthamdy@yahoo.com 01001224979 elmesaha -elharam
City Postal code Country Position/Affiliation
Giza Egypt associate professor- faculty of physical therapy, cairo university
Role Name Email Phone Street address
Public Enquiries basant elrefaey bassanthamdy@yahoo.com 01001224979 elmesaha -elharam
City Postal code Country Position/Affiliation
Giza Egypt associate professor- faculty of physical therapy, cairo university
Role Name Email Phone Street address
Scientific Enquiries basant elrefaey bassanthamdy@yahoo.com 01001224979 elmesaha -elharam
City Postal code Country Position/Affiliation
Giza Egypt associate professor- faculty of physical therapy, cairo university
REPORTING
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