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CTRI Number  CTRI/2019/08/020848 [Registered on: 22/08/2019] Trial Registered Prospectively
Last Modified On: 08/02/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effect of exercises given during dialysis to improve quality of life of patients undergoing haemodialysis.  
Scientific Title of Study   A Randomized control trial to study the Effect of Intradialytic Exercises on Maximal Oxygen Consumption and Quality of life Undergoing Haemodialysis in Indian Population 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Seema Grover 
Designation  Chief Physiotherapy & Rehabilitation 
Affiliation  Apollo Hospitals Educational and Research Foundation (AHERF) 
Address  Indraprastha Apollo Hospitals Sarita Vihar Delhi Mathura Road New Delhi 110076
Indraprastha Apollo Hospitals Sarita Vihar Delhi Mathura Road New Delhi 110076
South
DELHI
110076
India 
Phone  9958819222  
Fax    
Email  seema_g@apollohospitalsdelhi.com  
 
Details of Contact Person
Scientific Query  
Name  Seema Grover 
Designation  Chief Physiotherapy & Rehabilitation 
Affiliation  Apollo Hospitals Educational and Research Foundation (AHERF) 
Address  Indraprastha Apollo Hospitals Sarita Vihar Delhi Mathura Road New Delhi 110076
Indraprastha Apollo Hospitals Sarita Vihar Delhi Mathura Road New Delhi 110076
South
DELHI
110076
India 
Phone  9958819222  
Fax    
Email  seema_g@apollohospitalsdelhi.com  
 
Details of Contact Person
Public Query  
Name  Seema Grover 
Designation  Chief Physiotherapy & Rehabilitation 
Affiliation  Apollo Hospitals Educational and Research Foundation (AHERF) 
Address  Indraprastha Apollo Hospitals Sarita Vihar Delhi Mathura Road New Delhi 110076
Indraprastha Apollo Hospitals Sarita Vihar Delhi Mathura Road New Delhi 110076
South
DELHI
110076
India 
Phone  9958819222  
Fax    
Email  seema_g@apollohospitalsdelhi.com  
 
Source of Monetary or Material Support  
Apollo Hospitals Educational and Research Foundation AHERF 
 
Primary Sponsor  
Name  Apollo Hospitals Educational and Research Foundation AHERF 
Address  Flat no. 1/16 & 1/17, IInd Floor Krishna Deep Chambers Apollo Hospitals – Annexe No. 1 - Wallace Garden, Thousand Lights Chennai – 600 006, Tamil Nadu  
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 
SEEMA GROVER  INDRAPRASTHA APOLLO HOSPITALS  SARITA VIHAR,MATHURA ROAD,NEW DELHI 110076
South
DELHI 		 9958819222

seema_g@apollohospitalsdelhi.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ECR/5/Inst/DL/2013/RR-16 INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z048||Encounter for examination and observation for other specified reasons,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  A Randomized control trial to study the Effect of Intradialytic Exercises on Maximal Oxygen Consumption and Quality of life Undergoing Haemodialysis in Indian Population  1. Introduction to patient about study 2. Benefits of study to be explained to subjects 3. Informed consent 4. Pre-exercise assessment (detailed history &vitals to be checked) 5. Six minute walk test, Sf-36, Pittsburgh scale, anxiety and depression inventory 6. Subject to be made comfortable, relaxed and followed by intervention. 7. Intradialytic exercises 7.1 Warm up phase:diaphragmatic breathing 7.2. Main Phase 7.2.1 Aerobic Cycling 7.2.2 Resistance Free-weight dumbbell weighted ankle cuff Thera band (either one of the three depending on patient’s condition as per physician clearance) 7.3 Cool-Down Phase Diaphragmatic Breathing 8. Post - exercise assessment (vitals ) 9. Intervention continues for 3 months 10. All the assessment to be noted as pre intervention and post intervention at the given time points. 11. comparision and analysis to be done.  
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age -30-60
2. Haemoglobin > 10 mmHg
3. No hospitalizations during the previous 3 months, except for vascular access repair;
4. No amputations or prostheses in lower extremities
5. Able to ambulate and ability to complete all study protocol tests
6. Likelihood of good compliance to the protocol.
 
 
ExclusionCriteria 
Details  1. Acute infectious or other inflammatory illnesses
2. Current heart failure, lung failure, severe liver disease, or active cancer except basal cell carcinoma
3. Myocardial infarction or angina pectoris within the past 12 months.
4. Disapproval by physician
5. pregnancy, kidney transplant within 6 months
6. visual or hearing impairment
7. Inability to give informed consent
8. Patient having femoral fistula as access for Haemodialysis
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1.SF-36. 2.Pittsburgh sleep quality index 3. Vo2 max 4. Rate of perceived exertion  3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Improved quality of life.
2. Improved functional capacity.
3.Improved endurance.
4. Improved biochemical parameters. 		 3 months 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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)   01/09/2019 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details
Modification(s)  		 Results of study to be published in a peer review in Index journal. 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Purpose and significance of the study

The purpose of this interventional study is to examine the effect of intradialytic exercises on maximal oxygen consumption in patients undergoing Haemodialysis in Indian population.

Significance of the study

1. By obtaining results from this study we would be able to implement exercise program in patients who are undergoing haemodialysis more frequently.

2. Effect of physical activity in improving their quality of life can be easily assessed and better measures can be taken to prevent further complications of long standing hours of haemodialysis.

Objectives of the study

1.     To find the effect of intradialytic exercises on quality of life in chronic kidney disease patient undergoing haemodialysis in India.

2.     To find the difference in physical performance pre and post physical therapy session.

3.     To find the difference in maximal oxygen consumption after the 3 months of physiotherapy intervention.

 Expected outcome

Significant relationship between intradialytic exercises and maximal oxygen consumption improving quality of life, and general health outcomes of patient who are undergoing haemodialysis would be ascertained .Based on the protocol a regimen would be created for patients undergoing haemodialysis for betterment of physical performance.


 
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