| CTRI Number |
CTRI/2025/11/098164 [Registered on: 27/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Measuring body size and muscle strength in patients undergoing kidney dialysis |
|
Scientific Title of Study
|
Anthropometry and handgrip strength analysis in chronic kidney disease patients on maintenance hemodialysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Renaponi W Khuvung |
| Designation |
Post graduate student |
| Affiliation |
Manipal College Of Health Professions MAHE Manipal |
| Address |
LH 11 6th floor Manipal College Of Health Professions MAHE Madhav Nagar Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
8415866941 |
| Fax |
|
| Email |
renaponik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan VB |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Nephrology Kasturba Medical College and Kasturba Hospital MAHE Madhav Nagar Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan VB |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College and Kasturba Hospital |
| Address |
Department of Nephrology Kasturba Medical College and Kasturba Hospital MAHE Madhav Nagar Manipal Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9902548725 |
| Fax |
|
| Email |
mohan.vb@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Nephrology dialysis unit 3rd floor Kasturba Hospital Manipal Karnataka 576104 India |
|
|
Primary Sponsor
|
| Name |
Renaponi W Khuvung |
| Address |
LH 11 6th floor Manipal College Of Health Professions MAHE Madhav Nagar Manipal Karnataka 576104 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Dr Mohan VB |
Kasturba Hospital |
Department of Nephrology dialysis unit 3rd floor Manipal Karnataka 576104 India
Udupi
KARNATAKA |
9902548725
mohan.vb@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N186||End stage renal disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Age 18 years and above
CKD patients on Hemodialysis for more than 3 months
|
|
| ExclusionCriteria |
| Details |
Patients admitted in ICU
AKI patients
Patients with hand deformities
Non-consenting patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Anthropometric measurements using a vernier caliper including BMI skinfold thickness and mid upper arm circumference to evaluate the nutritional and body composition status of hemodialysis patients.
2 Handgrip strength measurement using a handgrip dynamometer to evaluate muscle strength and functional status of hemodialysis patients. |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="115"
Sample Size from India="115"
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)
|
10/12/2025 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is an observational study to evaluate the nutritional status and muscle health of chronic kidney disease CKD patients undergoing maintenance hemodialysis by assessing their
anthropometric measurements and handgrip strength. By combining these two
non invasive assessments using a vernier caliper for body measurements and a
dynamometer for muscle strength the study aims to provide a more accurate and
comprehensive understanding of the patients nutritional and functional
condition which can help guide better clinical management and improve patient
outcomes. |