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.: PACTR202302873028626 Date of Approval: 01/02/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title difference between high intensity interval and moderate intensity continous intradialytic exercise on muscle quality index in hemodialysis patient
Official scientific title INTERVAL VERSUS CONTINOUS INTRADIALYTIC TRAINING ON MUSCLE QUALITY INDEX AND FUNCTIONAL CAPACITY IN HEMODIALYSIS PATIENTS
Brief summary describing the background and objectives of the trial Individuals with CKD (both predialysis and ESRD) may be at greater risk of sarcopenia given the combined reductions in physical function, skeletal muscle performance and skeletal muscle mass (Androga et al., 2017).This study will be conducted to find out the effect of interval versus continous intradialytic training on muscle quality index and functional capacity in Hemodialysis patients. Study include sixty male patients on hemodialysis for 1-3 years aged from 45 to 55 years old selected from hemodialysis unit at National Institute of Urology and Nephrology.Patients will be assigned randomly by computerized block randomization into two groups: Group (A): 30 patients will participate in 8 weeks of aerobic exercise in the form of high intensity interval training (HIIT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week).Group (B): 30 patients will participate in 8 weeks of aerobic exercise in the form of moderate intensity continous training (MICT) intradialytic pedaling exercise plus hemodialysis (3 sessions per week). Karvonen formula will be used to calculate training heart rate. primary and secondary variables will be measured before study beginning and after completion.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease,Musculoskeletal Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 10/01/2023
Actual trial start date 03/01/2023
Anticipated date of last follow up 10/05/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Closed to recruitment,follow-up continuing
Publication URL not yet
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 Non-randomised 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 aerobic exercise Each training session consist of three parts of 30 minutes Training program will last for 8 weeks with frequency 3times / week. - Warm up (5 minutes) free active exercise of the lower extremities, - Training continued with three exercise intervals lasting 3 min each, at an exercise intensity of 85%–95% of HRpeak equalling 15–17 on the Borg scale. Each interval was separated by 4 min of active breaks at an intensity of 60%–70% of HRpeak. - Cool down (5 minutes) free exercise of lower extremities. 30
Experimental Group moderate intensity continous aerobic exercise Each training session consist of three parts of 30 minutes Training program will last for 8 weeks with frequency 3times / week. - Warm up (5 minutes) free active exercise of the lower extremities, -Training continued with cycling at low-to-moderate exercise intensity of 50%–60% of HRpeak, representing 11–13 on the Borg scale. - Cool down (5 minutes) free exercise of lower extremities. 30
Control Group no intervention no intervention no intervention no intervention 0 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients will be included if they meet the following criteria: 1. Age between 45– 55 years. 2. Male sex included. 3. Patients with grade 5 chronic renal failure on hemodialysis. 4. Patients are on hemodialysis for 1-3 years. 5. Body mass index (BMI) range from 25-34.9 Kg/m2. 6. They will be medically and psychologically stable. 7. Receiving their physician-prescribed pharmacotherapy regularly. 8. Agree to participate by signing an informed consent form. 1. Inability to comprehend and follow instructions as in dementia or speech problems such as dysphasia. 2. Patients with unstable angina, uncontrolled cardiac arrhythmia, decompensated heart failure, persistent systolic blood pressure (BP) greater than 200 mmHg, persistent diastolic BP greater than 120 mmHg, acute pericarditis or myocarditis. 3. Acute systemic infection. 4. Presence of malignant disease. 5. Patients with Diabetes Mellitus. 6. Patients with Lupus Nephritis. 7. Patients with chronic obstructive lung disease, restrictive lung disease or chronic chest infection. 8. Severe obesity (BMI > 35). 9. Chronic inflammatory orthopedic disorders and rheumatoid arthritis. 10. Patients with muscle injuries or neuromuscular disorders (muscular dystrophy, myasthenia gravis, myopathy, multiple sclerosis and peripheral neuropathy). Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 55 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 11/12/2022 faculty of physical therapy ethical committe
Ethics Committee Address
Street address City Postal code Country
ahmed elzayat st, elbehoos, giza giza 12611 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome - Muscle quality index: to measure muscle quality and function MQI (Watts) = ((Leg length×0.4) ×Bodymass×gravity×10) ∕ Time taken for (sit to stand 5 times) - Six minute walk test (6MWT) to assess physical functional capacity - QOL by using the questionnaire “Medical Outcomes Study 36 (SF36) at beginning of treatment and after 8 weeks
Secondary Outcome kidney function urea, creatinine, BUN , creatine phosphokinase total and CPK-MB at beginning of study and after 2 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the national institute of urology and nephrology elmatareya st cairo 4540046 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Hadeer saber Mansour 10 eltony st, elharam giza 61652 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor hadeer saber mansour eltony st elharam cairo 3753450 Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Public Enquiries hala mohamed ezz eldeen hala.ezzeldeen@pt.cu.edu.eg 01006626043 eltahrir st , dokki , giza
City Postal code Country Position/Affiliation
giza 12611 Egypt professor of physical therapy cairo university
Role Name Email Phone Street address
Principal Investigator nesreen ghareeb elnahas nesreen.elnahas@pt.cu.edu.eg 01002227242 el dokki st , giza
City Postal code Country Position/Affiliation
giza 12611 Egypt professor of physical therapy cairo university
Role Name Email Phone Street address
Scientific Enquiries tarek fakhreldeen othman tarek.fakhr@yahoo.com 01066426125 elhoreya st , elmatareya
City Postal code Country Position/Affiliation
cairo 4540046 Egypt lecturer of internal medicine and nephrology at the national institute of urology and nephrology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individual participant data that underlie the results after deidentification (text,tables, figures and appendices ) will be available Study Protocol beginning 9 months and ending 36 months following article publication investigators whose proposed use of the data has been approved by an independent review committee
URL Results Available Results Summary Result Posting Date First Journal Publication Date
after 36 months the data will be available in our unviersity Pt. cu.edu.eg 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