Effect of Exercise in Obese Patients With Chronic Kidney Diseases
Phase: NA
Conditions: Chronic Kidney Failure
Sponsor: Cairo University

Updated 23/11/12 
 
 
1
---- 
FACULTY OF PHYSICAL THERAPY 
APPLICATION FOR ETHICAL REVIEW 
 
 
 
NOTES: 
 
 
Answers to questions must be entered in the space provided. 
 
An electronic version of the completed form should be submitted to the Research Ethics Officer, at the 
following email address: …ethical@pt.cu.edu.eg……. Please do not submit paper copies. 
 
If you have any queries about the form, please address them to the Research Ethics Team. 
 
 
 

Updated 23/11/12 
 
 
2
FACULTY OF PHYSICAL THERAPY 
APPLICATION FOR ETHICAL REVIEW 
OFFICE USE ONLY: 
Application No: 
Date Received: 
 
1. TITLE OF PROPOSAL  
 
Effect of exercise in obese patients with chronic kidney diseases 
 
2. THIS PROPOSAL IS:  
 
Physical Therapy Staff Research Proposal √√ √√ 
 
 
Physical Therapy Postgraduate Research (PGR) Student Proposal 
 
Master 
 
Doctoral 
 
Other √ 
 
 
          Other  
  (Please specify):        
 
 
3. INVESTIGATORS  
 
a) PLEASE GIVE DETAILS OF Student (FOR PGR STUDENT PROPOSAL) or first author for 
staff Research Proposal 
 
Name:      Title / first name / family name 
Dr. Manal Kamel Youssef 
Highest qualification & position held: 
Assistant professor of Physical Therapy  
Department/ Faculty/ University 
- Physical therapy, department of internal medicine, Cairo 
university hospitals - Cairo University 
 
Telephone: 
01007734694 
Email address: 
Manal.kamel@cu.edu.eg 
 
 
a) PLEASE GIVE DETAILS OF ANY CO-SUPERVISORS OR CO-INVESTIGATORS (FOR PGR 
STUDENT PROPOSAL) or co- first author for staff Research Proposal 
 
Name:      Title / first name / family name 
 
Highest qualification & position held: 
 
Department/ Faculty/ University  
 
Telephone: 
 
Email address: 
 
 
4. SUMMARY OF PROPOSAL 
 
PURPOSE: To compare between the effect of aerobic exercise and resistance exercises on 
patients with obese chronic kidney diseases. 
BACKGROUND: excessive adiposity is well recognized as an amplifier for the risk of renal disease 
progression in patients with chronic kidney diseases of various aetiology. Renal alterations induced 
by obesity include hyperfiltration, pathological proteinuria/ albuminuria and reduced glomerular 
filtration rate 
HYPOTHESES: There will not significantly effect of neither aerobic nor resistance on obesity, in 
patient with chronic kidney disease. 
RESEARCH QUESTION: Aerobic exercise and resistance exercise which of them has significant 
effect on obesity in patient with chronic kidney disease? 

Updated 23/11/12 
 
 
3
5. CONDUCT OF PROJECT 
 
 
Please give a description of the research methodology that will be used 
Therapeutic Procedures 
Group(1): Each exercise training session included 3 to 5 minutes of warm-up, range-of-motion 
exercises, interval training(aerobic training), cool-down, and post-exercise range-of-motion 
exercises. Patients exercise at40 to 60% of maximum heart rate. 
Group(2): Resistance exercise training of the lower extremities was performed three times per 
week. Starting weights for knee extension and hip abduction and flexion were determined from a 
three-repetition maximum (3RM) using ankle weights that can be adjusted in 1 lb. increments. A 
3RM is the maximum weight that can be lifted three times with proper technique. Training started 
at approximately 60% of 3RM for two sets of 10 repetitions and was increased to three sets as 
tolerated. 
 
:
For evaluation the following instruments will be used
 
1-Timed-Up-and-Go Test (TUG).
 
2-sit-to-stand tests (STS).  
STS5 (the time taken to complete 5 sit-to-stand-to-sit cycles) is a surrogate measure of 
muscle power  
3- STS60 (number of sit-to-stand-to-sit cycles in 60 s) is a surrogate measure of muscular 
endurance.
 
4- 6 minutes walking test.
 
5-Blood pressure (systolic/diastolic blood pressures).
 
6-Mean blood pressure. 
7- heart rate (HR) were measured before and after test.  
8- blood glucose was measured before exercise by on call plus made in USA. 
9-BMI 
10-Waist circumference 
11-Waist to hip ratio 
. 
6. PARTICIPANTS AS THE SUBJECTS OF THE RESEARCH 
Describe the number of participants and important characteristics (such as age, gender, intellectual 
ability etc.). Specify any inclusion/exclusion criteria to be used. 
        
          
          7. RECRUITMENT 
Please state clearly how the participants will be identified, approached and recruited.  
 
 
Note: Attach a copy of any poster(s), advertisement(s) or letter(s) to be used for recruitment. 
60 obese diabetic patients with chronic kidney diseases (36 males and 24 females) (BMI) >30 
kg/m2, age between 26 and 60 years, divided randomly into two groups: 
 
Inclusion criteria: 
chronic kidney diseases Stages 2-4 
BMI ≥30 
Diabetes mellitus 
 
Exclusion Criteria 
uncontrolled hypertension or diabetes mellitus. 
cardiac failure, 
motor disorders,  
dementia. 
 

Updated 23/11/12 
 
 
4
participants will be recruited from referral to physical therapy, department of internal medicine, Cairo 
university hospitals, Giza, Egypt. 
 
7. CONSENT  
Describe the process that the investigator(s) will be using to obtain valid consent.  If consent is not to 
be obtained explain why. If the participants are minors or for other reasons are not competent to 
consent, describe the proposed alternate source of consent, including any permission / information 
letter to be provided to the person(s) providing the consent. 
I am                              freely and voluntarily consent to participate in a research program under the 
direction of Dr. Manal Kamel Youssef 
A thorough description of the procedure has been explained and I understand that I may withdraw 
my consent and discontinue participation in this research at any time without prejudice to me. 
Date                                                               Participant 
 
                          
                                                                                        
 
 
 
 
     Note: Attach a copy of the Consent Form, Participant Information Sheet (if applicable).  
   
 
PARTICIPANT WITHDRAWAL  
 
a) Describe how the participants will be informed of their right to withdraw from the project.  
the researcher will explain right of withdrawal from the study and this right is signed in consent 
form. 
 
b) Explain any consequences for the participant of withdrawing from the study and indicate what will 
be done with the participant’s data if they withdraw. 
 
there will be no problem about participant’s withdrawal from the study and his data will not be 
included in the statistical analysis. 
 
8. CONFIDENTIALITY 
 
   
 
 
a) 
Will all participants be anonymous?  
 
 
 
Yes √ 
              No 
 
b) 
Will all data be treated as confidential? 
 
 
 
Yes √ 
 
   No 
 
 
Note: Participants’ identity/data will be confidential if an assigned ID code or number is used, but it will 
not be anonymous. Anonymous data cannot be traced back to an individual participant. 
 
9. RISKS 
 
         Outline any potential risks to INDIVIDUALS, including research staff, research participants, other 
individuals not involved in the research and the measures that will be taken to minimise any risks and 
the procedures to be adopted in the event of mishap 
 
Overload of exercises may lead to muscle soreness and fatigue. 
These avoided by adjustment of intensity of exercises 
 
 
 
 
 
 
10. DECLARATION BY APPLICANTS 
 
I submit this application on the basis that the information it contains is confidential and will be used by the 
Faculty of Physical Therapy for the purposes of ethical review and monitoring of the research project  
described herein, and to satisfy reporting requirements to regulatory bodies.  The information will not be 
used for any other purpose without my prior consent. 
 

Updated 23/11/12 
 
 
5
I declare that: 
• 
The information in this form together with any accompanying information is complete and correct to 
the best of my knowledge and belief and I take full responsibility for it. 
• 
I will report any changes affecting the ethical aspects of the project to the Faculty of Physical 
Therapy Research Ethics Officer. 
• 
I will report any adverse or unforeseen events which occur to the relevant Ethics Committee via the 
Faculty of Physical Therapy Research Ethics Officer. 
 
 
Name of Principal investigator/project supervisor: 
 
Manal Kamel Youssef 
 
Date: 
29-12-2019