| CTRI Number |
CTRI/2024/05/066809 [Registered on: 06/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Functional Capacity and SpO2 in CKD: Evaluation with 2-Minute Walk Test |
|
Scientific Title of Study
|
Validity And Reliability Of 2 Min Walk Test To Assess Functional Capacity And
SPO2 In Patients With Chronic Kidney Disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Varnita Khandelwal |
| Designation |
undergraduate student |
| Affiliation |
MGM Institue of Physiotherapy |
| Address |
department of Cardiovascular and respiratory physiotherapy, Chhatrapati Sambhajinagar 12 , Rajdeep Apartment , N-5 CIDCO,Chh. Sambhaijnagar.
MAHARASHTRA
431003
INDIA
Aurangabad MAHARASHTRA 431003 India |
| Phone |
7498629763 |
| Fax |
|
| Email |
varnitakhandelwal129@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Manish P Shukla |
| Designation |
Associate professor |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
department of Cardiovascular and respiratory physiotherapy, Chhatrapati Sambhajinagar Jai Serenity Apartment , Gadiya Vihar road Shahnoorwadi Chh Sambhainagar
Aurangabad
MAHARASHTRA
431003
INDIA
Aurangabad MAHARASHTRA 431003 India |
| Phone |
9960290614 |
| Fax |
|
| Email |
manish.shukla20@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Varnita Khandelwal |
| Designation |
Undergraduate student |
| Affiliation |
MGM Institute of Physiotherapy |
| Address |
department of Cardiovascular and respiratory physiotherapy, Chhatrapati Sambhajinagar 12 , Rajdeep Apartment , N-5 CIDCO,Chh. Sambhaijnagar.
MAHARASHTRA
431003
INDIA
Amravati MAHARASHTRA 431003 India |
| Phone |
7498629763 |
| Fax |
|
| Email |
varnitakhandelwal129@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM medical college , Chhatrapati Sambhajinagar, Maharashtra, India. Pin Code 431003 |
|
|
Primary Sponsor
|
| Name |
MGM Institute OF Physiotherapy |
| Address |
N-6, CIDCO,Chhatrapati Sambhajinagar, Maharashtra, India. Pin Code 431003 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Varnita Khandelwal |
MGM Medical College & Hospital |
MGM Medical college & Hospital Kidney ward-356, Nephrology Department,5th floor
Chhatrapati Sambhaji nagar Aurangabad MAHARASHTRA |
7498629763
varnitakhandelwal129@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutuional Ethical Committe , MGM Institute of Physiotherapy Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N189||Chronic kidney disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patients with ckd undergoing dialysis |
|
| ExclusionCriteria |
| Details |
patienys having recent MI
unstable angina
musculoskeletal disoders
cognitive issues |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
walking distance
saturation of oxygen
rate of percived exertion |
Baseline, Immediately after the test & 3 minute after the test
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| heart rate , respiratory rate |
before and immediately after 2 and 6 minute walk test |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
15/05/2024 |
| 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="1" 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
|
Although the 6minute walk test is reliable and valid test to evaluate functional capacity in CKD patient’s .Nevertheless, it is also recognized that CKD patients experience muscular tiredness and weakness, hence 6minute walk test can be exhausting. As a result, 2MWT is more significant and equally valid and reliable test. Since, 2MWT takes less time, it can help CKD patients with high muscular tiredness and fatigue. The validity and reliability of a test are determined by its target participants. To the authors knowledge the validity and reliability of 2MWT in measuring functional capacity in CKD patients have not yet been examined.
The primary outcome in the 2MWT is the 6-min walk distance (6MWD), which can be used for exercise prescription and is also suitable for pre- and post-CR outcome assessment . Maintaining adequate physical endurance in later year is important to prevent Frailty and loss of independence,
|