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CTRI Number  CTRI/2018/11/016472 [Registered on: 30/11/2018] Trial Registered Prospectively
Last Modified On: 30/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [low intensity intra-dialytic exercises]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Effectiveness of exercises done during hemodialysis on renal function and fatigue. 
Scientific Title of Study   Astudy to evaluate the effect of Low-intensity Intra-dialytic exercises on serum urea-creatinine clearance and fatigue levels of patients undergoing hemodialysis at a tertiary care hospital. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anubha Devagourou 
Designation  student 
Affiliation  College of Nursing, AIIMS 
Address  College of Nursing, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9818259402  
Fax    
Email  anjulog02@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Kamlesh Sharma 
Designation  Lecturer 
Affiliation  College of Nursing, AIIMS 
Address  College of Nursing, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9811336985  
Fax    
Email  kamlesh_con@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Anubha Devagourou 
Designation  student 
Affiliation  College of Nursing, AIIMS 
Address  College of Nursing, AIIMS, New Delhi

South
DELHI
110029
India 
Phone  9818259402  
Fax    
Email  anjulog02@yahoo.co.in  
 
Source of Monetary or Material Support  
Renal Lab AIIMS, New Delhi 
 
Primary Sponsor  
Name  Anubha devagourou 
Address  AIIMS, New Delhi 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Anubha Devagourou  AIIMS, New Delhi  Hemodialysis Unit, AB4 ward, Department of Nephrology
South
DELHI 		 9818259402

anjulog02@yahoo.co.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post Graduate Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N185||Chronic kidney disease, stage 5,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Low intensity intra-dialytic exercises  patient will perform the set of 6 low intensity intra-dialytic exercises 90 minutes after the start of hemodialysis. exercises will be repeated thrice at an interval of 10 minutes each. duration of each set of exercises is 10 minutes.  
Comparator Agent  usual care without low intensity intra-dialytic exercises..  subjects will receive usual care and will not be administered any intervention. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients having upper arm functional AV fistula (based on physician’s assessment) access.
2. Patients undergoing haemodialysis for >3months, two to three times a week for 4 hrs per treatment.
3. Age of patients: 15-65yrs.
4. Patients who are willing to participate, conscious and can communicate in Hindi/English language.
5. Patients are independently able to perform low intensity intradialytic exercises.
 
 
ExclusionCriteria 
Details  1. Patients with unstable hemodynamic status (based on physician’s assessment).
2. Patients with a history of angina in last 3months, any contra-indications to perform exercises (based on physician’s diagnosis)
3. Patients with foot ulcer, sores, pitting edema (based on clinical examination by physician).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Serum urea creatinine and fatigue levels  Serum urea creatinine and fatigue levels measured at 0, 2, 4 and 6 weeks. 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="56"
Sample Size from India="56" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="64" 
Phase of Trial   N/A 
Date of First Enrollment (India)   03/12/2018 
Date of Study Completion (India) 31/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Accepted for publication by Saudi Journal of Kidney Disease and Transplantation. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
•Physical exercises done during HD have positive influence on the physical and psychosocial parameters of the patient and does not cost extra time.
•Research studies have confirmed the safety and the effectiveness of intradialytic exercises on decreasing fatigue level and muscle cramps and increasing the efficacy of dialysis.
•Despite the knowledge and adequate evidence about intradialytic exercises, it is still not part of routine care of patients undergoing HD.
•Present study aims to generate further evidence to improve the efficacy of HD and reduce fatigue by the introduction of low intensity intradialytic exercises among CKD patients undergoing HD.
•This includes a set of six exercises (2 upper limb ( arm without HD access) and 4 lower limb).
•The intra-dialytic exercises will be done 90minutes after of start of HD.
•No. of repetitions for each exercises is 10/min.
•A set of exercises will be repeated thrice at an interval of 10 minutes between each set during HD
 
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