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.: PACTR202006810274251 Date of Approval: 24/06/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of endurance and strength training on left ventricular systolic function in hypertensive patients
Official scientific title Impact of endurance and strength training on left ventricular systolic function in hypertensive patients: A single-blind randomized controlled trial
Brief summary describing the background and objectives of the trial The influence of different types of exercises on pharmacologically treated hypertensive patients remains an area of intense research. While studies on the effects of endurance training have truly consistent outcomes, the strength training findings are scarce. This study aimed to assess the impact of both endurance and strength training on left ventricular systolic function in hypertensive patients and comparing their therapeutic potential.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 10/02/2020
Actual trial start date 01/03/2020
Anticipated date of last follow up 10/05/2020
Actual Last follow-up date 10/06/2020
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
Recruitment status Completed
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group strength training strength training at 50-70% of one-repetition maximum The exercises were carried out 30 minutes, three times a week for 12 weeks The strength training program comprises bench-pressing, seated-rowing, overhead shoulder-pressing, seated chest-pressing, lateral wide pull-down, stomach crunches, seated leg-pressing, seated leg curls, cable triceps Pushdowns, and seated dumbbell biceps curls. The exercises were carried out 30 minutes, three times a week for 12 weeks. Following an appropriate warming-up, carefully controlled training approaches were executed for patients in this group to reduce the chance of musculoskeletal insults. The intensity of exercise followed the Stepwise manner in which there was a progressive increment of 2.5% of 1RM. The exercises were carried out in 50-60% of 1MR in two sets of 10 repetitions throughout the first month. However, the intensity rose in the subsequent two months to 60-70% of 1MR in three sets with 10 repetitions. Exercises were carried out with 90-120 seconds of rest between each set of exercise 15
Experimental Group endurance training endurance exercise at 60-75% of maximum heart rate The exercises were carried out 30 minutes, three times a week for 12 weeks. After warming-up, patients of this group executed walking on a treadmill at moderate speed with no tendency three times a week on non-sequential days. The time of the exercise was raised from 15 minutes at 60% of max HR to 30 minutes at 75% of max HR per session. The intensity of exercise was defined by the Karvonen equation where the target heart rate = [(max HR − resting HR) × % intensity] + resting HR, where the max HR = 220-age. Patients are guided to preserve their level of perceived exertion within 13 and 14 on the Borge scale. 15
Control Group control none 12 weeks the control group that carried out the regular daily activities alongside administering their medication 15 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
they had stable primary hypertension that was pharmacologically controlled with no modification during the intervention or follow-up, they had no evidence of diabetes mellitus or other systemic diseases apart from hypertension for at least the past six months, they had a quiescent lifestyle. Patients with secondary hypertension LV wall motion abnormality or impaired LV ejection fraction <45% heart failure, heart valvular disease, coronary artery disease, cardiac arrhythmia, previous stroke, diabetes mellitus evidence of severe cerebrovascular disorder profound musculoskeletal challenges limiting their physical fitness Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 65 Year(s) Both
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 05/01/2020 Cairo University Ethics Board for Scientific Research
Ethics Committee Address
Street address City Postal code Country
7 Ahmed Elzayat Dokki 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Left Ventricular Ejection Fraction (LVEF) and Left Ventricular Fractional Shortening (LVFS) at baseline and after 12 weeks of training
Secondary Outcome Left Ventricular End Diastolic Diameter (LVEDD) at baseline and after 12 weeks of training
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo University 7 Ahmed Elzayat Dokki 12613 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Yasser M. Aneis 7 Ahmed Elzayat Dokki 12613 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yasser M. Aneis dryassercom@yahoo.com 00201011228823 7 Ahmed Elzayat
City Postal code Country Position/Affiliation
Dokki 12613 Egypt associate professor of physical therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Mona Taha Monady2007@yahoo.com 00201111351518 2-street 9
City Postal code Country Position/Affiliation
Helwan 11722 Egypt associate professor of physical therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Gaber Solima gabersayed238@yahoo.com 00201011228823 7 Ahmed Elzayat
City Postal code Country Position/Affiliation
Dokki 12613 Egypt associate professor of physical therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trial, after de-identification. Clinical Study Report,Study Protocol immediately following publication. no end date. anyone who wishes to access the data. for any purpose.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
URL will be added later No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information