| CTRI Number |
CTRI/2018/05/014138 [Registered on: 25/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
16/04/2018 |
| 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
|
Benefit of exercises for patients undergoing dialysis |
|
Scientific Title of Study
|
To study the effect of interdialytic exercises in middle aged and elderly chronic kidney disease patients. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SSRIDEVI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI RAMACHANDRA UNIVERSITY |
| Address |
FACULTY OF PHYSIOTHERAPY
SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE(DEEMED TO BE UNIVERSITY) 1,RAMACHANDRA NAGAR,PORUR,CHENNAI
NO1,RAMACHANDRA NAGAR,PORUR CHENNAI-116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
ProfPSoundarrajan |
| Designation |
Professor and Head of the Department |
| Affiliation |
Saveetha University |
| Address |
Saveetha Medical College,
Saveetha nagar, Thandalam,chennai
Saveetha Medical College,
Saveetha nagar, Thandalam,chennai
Chennai
TAMIL NADU
602105
India |
| Phone |
8940827509 |
| Fax |
|
| Email |
drperiasamy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SSRIDEVI |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
SRI RAMACHANDRA UNIVERSITY |
| Address |
FACULTY OF PHYSIOTHERAPY,SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH INSTITUTE(DEEMED TO BE UNIVERSITY),NO1,SRI RAMACHANDRA NAGAR,PORUR CHENNAI
NO1,RAMCHANDRA NAGAR,PORUR CHENNAI-116
Thiruvallur
TAMIL NADU
600116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@gmail.com |
|
|
Source of Monetary or Material Support
|
| sri raamchandra medical college and research institute |
|
|
Primary Sponsor
|
| Name |
sri ramachandra medical college and research institute |
| Address |
1.ramachandra nagar,porur chennai-116 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SSRIDEVI |
E2,F2,GBLOCK DIALYSIS UNITSRI RAMCHANDRA MEDICAL CENTRE AND RESEARCH INSTITUTE |
1,RAMACHANDRA NAGAR,CHENNAI-116
Thiruvallur
TAMIL NADU |
9841401565
devibsmoorthy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sri raamchandra university institutional ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CHRONIC KIDNEY DISEASE PATIENTS UNDERGOING DIALYSIS, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
general advice and maintainence exercise for twelve weeks |
| Intervention |
experimental group |
exercises to all th joints,pedometers for twelve weeks |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
end stage renal disease undergoing haemodialysis
understand purpose of exercises
no musculoskeletal impairment
vitalsigns safe for exercising
stable cardiac profile |
|
| ExclusionCriteria |
| Details |
acute nephritic syndrome
profound anaemia and blood transfusion
underweent renal transplantation
absolute contraindication assper ACSM guidelines
on cytotoxic drugs
coagulation disorders
recent cerebrovascular accidents
recent cardiac surgeries |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
function-sit to stand,
quality of life-RAND 36,
nutritional status,biochemical paramaters-serum creatinine,c reactive protein,haemoglobin,blood glucose level,oxidative stress-vitamin-E,cardiovasscular paramaters-Echocardiogram,ECG |
at baseline,4 weeks,8 weeks,12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| interdialytic weeight gain,interdialytic blood pressure |
basseline,4 weeks,8weeks,12 weeks |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="200"
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 1 |
|
Date of First Enrollment (India)
|
11/01/2016 |
| 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="2"
Months="6"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NONE YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of the study is to find the effect of interdialytic exercises in middle aged and elderly population,As there is an tremendous increase in diabetes and hyperrtension there is a simulatenous increase in chronic kidney disease also and patients undergo renal replacement therapy in the form of haemodialysis. The patients undergoing need some form of structured exercise protocol and this study aims at providing one and study the effect of those exercises on these patients. |