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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201906776769795 Date of Registration: 28/06/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Determination of the better treatment of erectile dysfunction between exercise and electrical stimulation
Official scientific title Comparative Efficacy of Aerobic Exercise and Electrical Stimulation in the Management of Erectile Dysfunction
Brief summary describing the background and objectives of the trial The term male erectile dysfunction (ED) refers to a recurring and persistent condition where a man is unable to achieve or maintain an erection and complete sexual intercourse. ED is usually of multifactorial origin atherosclerosis affecting the pelvic vasculature identified as the major cause. However, conditions associated with reduced nerve and endothelium function, such as aging, hypertension, smoking, hypercholesterolemia, and diabetes, also alter the balance between contraction and relaxation factors. Therapeutic options for men with ED are mainly pharmacological. However, all of these methods circumvent the patient’s problem temporarily, and patients are not cured of impotence, patients typically remain dependent on these treatments for the remainder of their sexually active lives. An effective treatment that cures the problem permanently is needed. Previous studies have shown an inverse relationship between physical activity levels and biomarkers of inflammation in both healthy individuals and subjects with cardiovascular condition. Many studies have indicated the role of aerobic exercise in the management of erectile dysfunction. Similarly, there were studies that demonstrated the effectiveness of penile electrical stimulation in the management of ED. Though both of these treatment approaches are cheap, relatively safe without much side effects, and easy to administer, no study was conducted to determine the most effective among them, and most importantly the characteristics of the patients that will best benefit from each. Therefore, this study is designed to investigate the comparative therapeutic efficacy of aerobic exercises and electrical stimulation in the management of ED. We hypothesized that exercise will be more effective.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) ED
Disease(s) or condition(s) being studied Urological and Genital Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 15/07/2019
Actual trial start date 15/07/2019
Anticipated date of last follow up 15/09/2019
Actual Last follow-up date 15/09/2019
Anticipated target sample size (number of participants) 24
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Exercise The exercise will be of low intensity, between 60% and 79% of their heart rate maximum (HR max) reserve (estimated from 220 minus the patient age as recommended by American College of SportsMedicine. There will be three sessions of aerobic exercise per week for 8 weeks. Each session will last for 45 minutes for the first two weeks which will be increased to 60 minutes in the remaining 6 weeks. Ergometer: The patient will sit on top of bicycle ergometer equipped with pedal straps and a power monitor. The starting workload will be 100 kgm (17 watts), which will be increased at a pedal speed of 50 revolutions per minute to obtain an HR max. 60%-70% of HR max will then be calculated and the patient will work at that rate for the duration of the exercise. Treadmill: The aerobic exercise will begin with Warm-up which will consist of light stretching and starting on the treadmill with a walk and progressing to a brisk walk. This will be followed by endurance training at 60%-75% HRmax for 30-50 minutes. In the end, there will be cool down on the treadmill at a pace of brisk walking for 5 minutes followed by stretching. 12
Control Group Electrical Stimulation The stimulation will be carried out using the following parameters: Pulse current: 120 mA. Frequency: 30 Hz Pulse/Pause Ratio: 1: 2 Contraction time: 3 seconds Three sessions of electrical stimulation will be given per week for 8 weeks. Each session will last for 20 minutes. The patient will lie down supine on the couch, the area to be treated will be exposed adequately. The treatment will be carried out by the researcher using an electrical stimulator. The electrical stimulation will be carried out by using the Erec-fit stimulation system with two monopolar self –adhesive electrodes. The pre-lubricated electrodes will be circularly placed on the penis and the current will be transferred to the inner muscular system and maximum tolerance level will be reached. 12 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Who are in stable medical condition? 2. Those with no history of psychiatry or psychological disorders will participate in the study. 3. Those between the age of twenty-five (25) and sixty-five (65) years. 4. Those with no cardiac pacemaker or renal problem 1. Those with uncontrolled high blood pressure. 2. Those with a cardiac pacemaker or renal problem. 3. Those below the age of twenty-five or above sixty-five years. 4. Those with penile skin lesion/ulcers. 5. Those with a history of priapism. Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 25 Year(s) 65 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 17/11/2014 Lagos University Teaching Hospital Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Ishaga Road, Idi-Araba, Lagos, Nigeria. Lagos 100254 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcome will be sexual function measured using the 5-item version of The International Index of Erectile Function (IIEF-5). This Questionnaire consists of only five questions and each IIEF-5 item is scored on a five-point ordinal scale where lower values represent a poorer sexual function. Thus, a response of 0 for a question will be considered the least functional, whereas a response of 5 was considered the most functional. The possible scores for the IIEF-5 range from 1 to 25 (one question has scores of 1-5), and a score above 21 Will be considered as normal erectile function and at or below this cutoff, according to this scale, ED is classified into four categories based on IIEF-5 scores: severe (1-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25). The sexual function will be measured before and after intervention.
Secondary Outcome Energy expenditure will be measured using the Bruce protocol. we will like to see the effect of aerobic exercise on sexual endurance of the patients in the exercise group. The Bruce Protocol is a maximal exercise test where the athlete works to complete exhaustion as the treadmill speed and incline is increased every three minutes. The length of time on the treadmill is the test score and can be used to estimate the VO2 max value. The protocol has 9 stages and each stage lasts for 3 minutes. As a general rule, a patient who completes the first two stages of the Bruce protocol has a functional capacity greater than 7 METs, which is considered sufficient for sexual intercourse. Before and after intervention only
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Neurology outpatient and physiotherapy outpatient clinic of Lagos University Teaching Hospital Ishaga Road, Idi-Araba, Lagos, Nigeria. Lagos 100254 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Rislanu Adamu Bama road, Maiduguri, Borno State, Nigeria. Maiduguri 600223 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Rislanu Ibrahim Adamu Bama Road, Maiduguri, Borno State, Nigeria Maiduguri 600230 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Auwal Bello Hassan Bama road, Maiduguri, Borno State. Maiduguri 600223 Nigeria
Dr. Adebiyi A.O. Lasu, Ojo Campus Ojo Local Government, 102101, Lagos Lagos 0001 Nigeria
Professor Akinwuntan O.T. Lagos State University, Lagos - Badagry Express Way. Lagos 0001 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rislanu Adamu rislanadamu@gmail.com +2348067453398 Department of Physiotherapy, University of Maiduguri Teaching Hospital, Bama Road, Maiduguri, Borno State, Nigeria.
City Postal code Country Position/Affiliation
Maiduguri 600230 Nigeria Principal Physiotherapist
Role Name Email Phone Street address
Public Enquiries Auwal Hassan auwalbello0907@yahoo.com +2349065867707 Bama Road, Maiduguri, Borno State, Nigeria.
City Postal code Country Position/Affiliation
Maiduguri 600230 Nigeria Lecturer II
Role Name Email Phone Street address
Scientific Enquiries Auwal Hassan auwalbello0907@yahoo.com +2349065867707 Bama Road, Maiduguri, Borno State, Nigeria.
City Postal code Country Position/Affiliation
Maiduguri 600230 Nigeria Lecturer II
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The data to be shared will include the demography of the patients, their sexual function measured using the 5-item version of The International Index of Erectile Function (IIEF-5), and their energy expenditure using Bruce protocol. Clinical Study Report Undecided Patients with erectile dysfunction between the age of twenty-five (25) and sixty-five (65) years, with no history of psychiatry or psychological disorders, and no cardiac pacemaker or renal problem.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information