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.: PACTR202112710463704 Date of Approval: 07/12/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of Aerobic Versus Resisted Intradialytic Exercises on Quality of Life in Patients with Chronic Kidney Disease (Randomized Control Trial)
Official scientific title Effect of Aerobic Versus Resisted Intradialytic Exercises on Quality of Life in Patients with Chronic Kidney Disease (Randomized Control Trial)
Brief summary describing the background and objectives of the trial BACKGROUND: Chronic kidney disease is the progressive deficiency of renal function for months and years, which may reach a life-threatening stage. Patients with chronic kidney disease have low levels of physical fitness and function. Exercise is one of the possible preventive maneuvers to reduce muscle protein loss and maintain muscle function PURPOSE: The purpose of this study is to determine the effect of Aerobic Versus Resisted Intradialytic Exercises on Quality of Life in Patients with Chronic Kidney Disease
Type of trial RCT
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 31/12/2021
Actual trial start date
Anticipated date of last follow up 31/03/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 30
Actual target sample size (number of participants)
Recruitment status Not yet 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group resistance exercise 2 times-weeks. For 2 months receive resistance exercise during the first two hours of dialysis. (intradialytic) using weights 15 Active-Treatment of Control Group
Experimental Group aerobic exercise 2 times –week for 2 months receive aerobic exercise during the first two hours of dialysis.(intradialytic)using stationary bicycle 15
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All patients with stage 4 of CRF, All patients were stable on dialysis for 2 months, All patients were free from lower extremity graft, Both genders participated in the study, Patient did not take exercise in 6 months before treatment, Blood pressure under medical control, Stable blood glucose. Active infection, inflammation, autoimmune disorder, and malignancy, Sever muscle weakness or skeletal problem, History of repeated hypoglycemia, Cardiopulmonary complication to resistive exercise, Cerebrovascular accident within 6 months before treatment, History of prior exercise training, Hospitalization during the prior month. Adult: 19 Year-44 Year 25 Year(s) 35 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 12/09/2021 Faculty of physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 ahmed elzyat bein srayat Giza Egypt Giza 11411 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Laboratory investigation: Urea ratio before and after intervention
Secondary Outcome Medical Outcome Study Questionnaire Short Form 36 Health Survey (SF-36) before and after intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Banha general hospital 7 banha street kaluob. Egypt 11511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Rania Nagy Karkousha 7 pot said street Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Banha general hospital 7 banha street Qluob Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Rania Nagy Karkousha 7 port said street Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rania Nagy Karkousha rania.nagy@pt.cu.edu.eg 01227244630 15 port said street
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of physical therapy Basic science department
Role Name Email Phone Street address
Public Enquiries Amira Hussin Draz amira.draz@pt.cu.edu.eg 01149411373 40 Maady street
City Postal code Country Position/Affiliation
Cairo Egypt Professor of physical therapy Basic science department
Role Name Email Phone Street address
Scientific Enquiries Nessrien Ghareb ElNahas nessrien.elnahass@pt.cu.edu.eg 01002227242 33 Agouza Street
City Postal code Country Position/Affiliation
Cairo Egypt Professor of physical therapy Cardiopulmonary Respiratory Disorders and Geriatrics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Clinical Study Report,Statistical Analysis Plan,Study Protocol 12 months period time after publication Controlling access to data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
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