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CTRI Number  CTRI/2023/09/058052 [Registered on: 26/09/2023] Trial Registered Prospectively
Last Modified On: 26/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of exercise on quality of life, functional ability and Blood Pressure among the hemodialysis patients. 
Scientific Title of Study   Effectiveness of intradialytic exercise on quality of life, functional ability and incidence of intradialytic hypotension among patients undergoing hemodialysis at a tertiary care hospital: a randomized controlled trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arushi Dhiman 
Designation  M.Sc Nursing 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  M.Sc Medical Surgical Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research ,Nightingale House, room no 329. Puducherry India.

Pondicherry
PONDICHERRY
605006
India 
Phone  7978257270  
Fax    
Email  arushidhiman1998@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mrs Angelin Mary Sheela 
Designation  Tutor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of Medical Surgical Nursing, College of Nursing, Jawaharlal Institute of Postgraduate Medical Education and Research. Puducherry India.

Pondicherry
PONDICHERRY
605006
India 
Phone  9489145542  
Fax    
Email  thirusheela@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Navin Kumar 
Designation  Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Department of physical and medical rehabilitation (PMR), Jawaharlal Institute of Postgraduate Medical Education and Research. Puducherry India.

Pondicherry
PONDICHERRY
605006
India 
Phone  8508528891  
Fax    
Email  kumarnavindr@gmail.com  
 
Source of Monetary or Material Support  
Intramural Research Fund Committee,JIPMER, Puducherry, 605006 
 
Primary Sponsor  
Name  Intramural Research Fund Committee 
Address  Intramural Research Fund Committee, JIPMER, Puducherry, 605006 
Type of Sponsor  Research institution and hospital 
 
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 
Dr Anand Babu  Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry 605006  Hemodialysis unit, department of Nephrology.
Pondicherry
PONDICHERRY 		 8608952436

anandababu1986@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Human studies, Jawaharlal Institute of Postgraduate Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N189||Chronic kidney disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  intradialytic exercise  Range of motion exercise will be done for 15 minute period of 2 sets after a 5 minute warm up period involving deep breathing exercise , during the first half of hemlodialysis session for 3 month of duration. 
Comparator Agent  Standard Hemodialysis care  Standard Hemodialysis care 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Age above 18 years.
History of Hemodialysis for more than 6 months.
Patients undergoing Hemodialysis for 4 hours, three times per week. 
 
ExclusionCriteria 
Details  1. History of MI in last 6 months.
2. Patient with Heart Failure NYHA stage more than three.
3. Patients with symptomatic Cardiovascular disease.
4. Patients with altered sensorium.
5. Patients with any physical disability.
6. Patients with unstable medical illness due to acute or chronic illness.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the effectiveness of intradialytic exercise on quality of life among patients undergoing hemodialysis.  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the effectiveness of intradialytic exercise on functional ability among patients undergoing hemodialysis.  3 months 
To identify the incidence of intradialytic hypotension among patients undergoing hemodialysis.  3 months 
 
Target Sample Size   Total Sample Size="74"
Sample Size from India="74" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   06/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   This study is a randomized controlled trial to assess the effectiveness of intradialytic exercise on quality of life, functional ability and incidence of intradialytic hypotension among patients undergoing hemodialysis at a tertiary care hospital. Patients who met the inclusion criteria will be enrolled from hemodialysis unit by consecutive sampling method. Informed consent will be obtained and the procedure will be performed for 15 minutes during the first half of hemodialysis. Initial data for every participant will be collected before the beginning of the procedure: Sociodemographic data, height, weight, BMI , number of dialysis per week, duration of each dialysis, comorbidities. Assessment of quality of life and functional ability will be done at the time of enrollment , after 1 month and after 3rd month of enrollment at the end of hemodialysis session. blood pressure will be assessed before , during and after each hemodialysis session for 3 months. Quality of life will be assessed by using KDQOL  tool and functional ability will be assessed by 6 minute walk test. 
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