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CTRI Number  CTRI/2024/01/061584 [Registered on: 18/01/2024] Trial Registered Prospectively
Last Modified On: 15/01/2024
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   Additive Effect Of Aerobic Exercise With Motivational Interviewing On Toxin Removal , Functional Capacity & Quality Of Life In Chronic Kidney Disease Patients  
Scientific Title of Study   Additive Effect Of Aerobic Exercise With Motivational Interviewing On Toxin Removal Functional Capacity & Quality Of Life In Chronic Kidney Disease Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Arshiya Ismail Sayyed 
Designation  Master Of Cardiovascular& Respiratory Physiotherapy Student 
Affiliation  Maharashtra Institute Of Physiotherapy  
Address  Maharashtra Institute of Physiotherapy MIMSR Medical Campus 15 Physiotherapy Cardiovascular Respiratory Department Ambajogai road Latur Latur

Latur
MAHARASHTRA
413531
India 
Phone  8956568562  
Fax    
Email  arshiyasayyed8956@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vishvanath Pawadshetty 
Designation  Professor & HOD of Cardiovascular & Respiratory Physiotherapy 
Affiliation  Maharashtra Institute Of Physiotherapy 
Address  Maharashtra Institute of Physiotherapy MIMSR Medical Campus 15 Physiotherapy CardiovascularRespiratory Department Ambajogai road Latur Latur

Latur
MAHARASHTRA
413 531
India 
Phone  9422710990  
Fax    
Email  physiovish@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vishvanath Pawadshetty 
Designation  Professor & HOD of Cardiovascular & Respiratory Physiotherapy 
Affiliation  Maharashtra Institute Of Physiotherapy 
Address  Maharashtra Institute of Physiotherapy MIMSR Medical Campus 15 Physiotherapy CardiovascularRespiratory Department Ambajogai road Latur Latur

Latur
MAHARASHTRA
413 531
India 
Phone  9422710990  
Fax    
Email  physiovish@gmail.com  
 
Source of Monetary or Material Support  
Maharashtra Institute of Physiotherapy Latur 
 
Primary Sponsor  
Name  Maharshtra institute of physiotherapy latur 
Address  Maharashtra Institute of Physiotherapy MIMSR Medical Campus Physiotherapy cardiovascular-respiratory department Ambajogai road latur Maharashtra 413512 India  
Type of Sponsor  Other [] 
 
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 Arshiya Sayyed  Maharashtra Institute of Physiotherapy   Maharashtra Institute of Physiotherapy MIMSR Medical Campus Physiotherapy Cardiovascular Respiratory Department Ambajogai road Latur
Latur
MAHARASHTRA 		 08956568562

arshiyasayyed8956@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Maharashtra Institute Of physiotherapy, Ethical Committee Latur  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  Group A Aerobic exercise with motivational interviewing Group B Motivational interviewing  Group A Aerobic exercise with motivational interviewing 2 times a week for 8 weeks Group B Motivational interviewing 2 times a week for 8 weeks 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Known case of chronic kidney disease( stage 3-5).
Patients willing to participate.
RPE (12-15 on Borg scale)
 
 
ExclusionCriteria 
Details  Unstable vitals
Restless leg syndrome
Recent episode of cerebrovascular accidents
Acute coronary syndrome, CCF, Severe pneumonia in st one month.
Musculoskeletal abnormalities (rheumatoid arthritis & osteoarthritis of knee and hip, fracture hip).
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Toxin level : Kidney function test
Functional capacity: 6 minute walk test.
Health related quality of life: Kidney disease quality of life questionnaire (KDQOL)
 		 Pre intervention assessment and post intervention assessment after 8 weeks of Intervention
 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   Phase 2 
Date of First Enrollment (India)   26/01/2024 
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="0"
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   Chronic kidney disease patients will be randomly selected and divided randomly into two groups. One group will be given motivational interviewing (8 weeks protocol) and other group will be given Aerobic exercise with motivational interviewing (8 weeks protocol). Toxin level(Kidney function test), Functional capacity using 6 minute walk test & Kidney disease quality of life questionnaire will be taken before the treatment and after 8 weeks of treatment. 
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