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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  
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 
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  
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  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  

Chronic kidney disease (CKD) is a major public health concern, characterized by a gradual and irreversible deterioration of kidney function over time   It is defined by the presence of structural or functional kidney abnormalities, as evidenced by decreased glomerular filtration rate (GFR) or increased urinary albumin excretion, persisting for more than three months   Prevalence In 2017, approximately 700 million cases of Chronic Kidney Disease (CKD) were reported globally, accounting for a prevalence rate of 9.1% (with a 95% uncertainty interval of 8.5 to 9.8). Since 1990, there has been a notable increase of 29.3% (with a range of 26.4 to 32.6) in CKD prevalence.

The clinical manifestations of CKD are complex and multi-systemic, affecting various organ systems beyond the kidneys. One of the prominent and debilitating effects of CKD is the impairment of skeletal muscle function and exercise capacity.

Patients with CKD often experience muscle atrophy, weakness, and reduced exercise endurance, leading to functional limitations and mobility restrictions.

In light of these limitations, there is a growing interest in exploring alternative assessment tools that can provide a more practical and less fatiguing evaluation of functional capacity in CKD patients. One such alternative is the 2-Minute Walk Test (2MWT), which has been investigated and validated in other patient populations, such as those with acute exacerbations of chronic obstructive pulmonary disease (COPD) and well-controlled asthma

The 2MWT is a shorter-duration walking test that may be better suited for CKD patients, as it requires less physical and cognitive effort while still providing valuable information about an individual’s functional status. 

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,

 
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