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.: PACTR201812776161905 Date of Approval: 14/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Metabolic Bone Changes After Intradialytic Resistive Exercise In Regular Hemodialysis Patients
Official scientific title Metabolic Bone Changes After Intradialytic Resistive Exercise In Regular Hemodialysis Patients
Brief summary describing the background and objectives of the trial Chronic kidney disease (CKD) patients frequently present disorders in calcium and phosphorus metabolism, decreased vitamin D activation, and increased parathyroid hormone (PTH) levels, which usually result in abnormalities in mineral and bone metabolism disorders. There are many strategies used to improve bone health in HD patients and recently, physical exercise appears to become one of them. Indeed, physical exercise may improve many indicators of physical functioning in CKD patients, and several studies have suggested that resistance exercise changes bone metabolism. So this study will be conducted to investigate the metabolic bone changes after intradialyticresistive exercise in regular hemodialysis patients. The following variables: Blood biochemistry (calcium, phosphorus and PTH), and quality of life will be evaluated before and after the exercise period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Kidney Disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/02/2018
Actual trial start date 01/02/2018
Anticipated date of last follow up 31/01/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants)
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 Numbered containers Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group intradialytic resistive exercise training three times per week. 12 weeks. The usual Hemodialysis sessions plus the resistive exercise program which consists of three parts: Part one: Warming up for 3 to 5 minutesin the form oflowerlimbsstretching exercise. Part two: The main part is the resistive exercises of lower limbs from supine position using weights in the form of sand bags. Part three: Cooling down for 3to 5 minutes in the form oflowerlimbsstretching exercise. 30
Control Group Hemodialysis sessions Three times per week 12 weeks. Usual Hemodialysis sessions only. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients are being regularly subjected to Hemodialysis, three times a week; both gender, being aged between 20 and 60 years; and not practicing in any exercise program. • History of malignancy or autoimmune diseases. • Uncontrolled arterial hypertension, • Ischemic cardiopathy • Deep vein thrombosis • Amputation • Epilepsy. • AIDS • Excessive pallor • Severe dyspnea • Uncontrolled diabetes. • Femoral fistula • Arrhythmias • Precordial pain • Orthopedic or neurological compromising • Patients have reasons to be in a catabolic state (including HIV). • Cognitive alterations affecting their participation in the proposed protocol. Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 20 Year(s) 60 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 15/04/2018 Faculty of Physical Therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza 12613 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Calcium, Phosphorus and PTH. Evaluation will be done before and after the exercise period.
Secondary Outcome Quality of life will be evaluated before and after the exercise period. Before and after the exercise period.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kasr El Aini Hospital Nephrology and Dialysis center. Kasr El-Aini st, El-Manial Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Emad Kameil Gaid Abdelnour 20 Mohamedd Talaat st., Agouza Giza Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of Physical Therapy Cairo University 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Nagwa Mohamed Badr 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza Egypt
Sahier Omar El Khashab El Manial , Kasr El Aeny st., Giza Egypt
Basant Hamdy El Refaey 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza Giza Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Emad Kameil Gaid Abdelnour emad.kameil@yahoo.com +201008928512 20 Mohamedd Talaat st., Agouza
City Postal code Country Position/Affiliation
Giza Egypt Senior Physical Therapist at Cairo University Hospitals
Role Name Email Phone Street address
Public Enquiries Emad Kameil Gaid Abdelnour emad.kameil@yahoo.com +201008928512 20 Mohamed Talaat st., Agouza
City Postal code Country Position/Affiliation
Giza Egypt Senior Physical Therapist at Cairo University Hospitals
Role Name Email Phone Street address
Scientific Enquiries Nagwa Mohamed Badr nagwambadr@yahoo.com +201223683849 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Sahier Omar El Khashab sahieee7@yahoo.com +201117145521 El Manial , Kasr El Aeny st.,
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor of Internal Medicine and Nephrology
Role Name Email Phone Street address
Scientific Enquiries Basant Hamdy El Refaey bassanthamdy@yahoo.com +201001224979 7 Ahmed ELzayat St. BienElsarayat, Dokky, Giza
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Emad Kameil Gaid Abdelnour emad.kameil@yahoo.com +201008928512 20 Mohamedd Talaat st., Agouza
City Postal code Country Position/Affiliation
Giza Egypt Senior Physical Therapist at Cairo University Hospitals
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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