| CTRI Number |
CTRI/2025/02/080868 [Registered on: 19/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Body Fat Distribution in People with Different Stages of chronic kidney disease |
|
Scientific Title of Study
|
Analysis of body fat distribution in different stages of 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 |
Sriman M |
| Designation |
Postgraduate Student |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical rehabilitation centre, new block OPD,
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9585238567 |
| Fax |
|
| Email |
srimanmurali8845@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mrs S Sridevi |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical rehabilitation centre, new block OPD, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mrs S Sridevi |
| Designation |
Associate Professor |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Physical rehabilitation centre, new block OPD, Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu
Kancheepuram
TAMIL NADU
600116
India |
| Phone |
9841401565 |
| Fax |
|
| Email |
devibsmoorthy@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sriman M |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar Porur, Chennai - 600 116 Tamil Nadu |
| Type of Sponsor |
Other [NIL] |
|
|
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 Sriman M |
Sri Ramachandra Faculty of Physiotherapy, Sri Ramachandra Institute of Higher Education and Research |
Physical rehabilitation centre, new block OPD, Sri Ramachandra institute of Higher education and research, Porur, chennai, India
Kancheepuram
TAMIL NADU |
9585238567
srimanmurali8845@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Ramachandra Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Different stages in chronic kidney disease, ambulatory male or female |
|
| ExclusionCriteria |
| Details |
Clinical signs of acute infection, Acute cancer or Liver dysfunction at time of evaluation, Severe heart failure, Amputated limbs |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body composition Analyser |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Hand Grip Strength, Skinfold Measurements, 4 Metre walking speed, Fatigue Severity Score, Kidney Disease Quality Of Life Measurement |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="125"
Sample Size from India="125"
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)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/03/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
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
|
Participant recruitment begins with identifying eligible individuals from the department and conducting preliminary screenings based on set criteria. Baseline data, such as demographics and clinical history, will be collected, followed by anthropometric measurements using standardized equipment. Body composition analysis will be performed using a bioelectrical impedance analyzer, ensuring participants adhere to pre-assessment guidelines like fasting and abstaining from exercise or caffeine. Muscle strength will be measured using a hand dynamometer, with two trials for each hand, recording the highest value. Subcutaneous fat will be assessed with skinfold calipers, averaging three measurements at specific anatomical sites. The 4-meter walking speed test will evaluate physical function, conducted twice to record the best time. Fatigue will be assessed using the Fatigue Severity Scale (FSS) questionnaire, and overall quality of life will be measured using the Kidney Disease Quality of Life (KDQOL) questionnaire, with participants supported as needed for accuracy and completeness. Both muscle mass and strength are crucial predictors of outcomes in CKD patients, who often experience catabolic protein-energy wasting. This study seeks to determine the prevalence of reduced muscle mass and strength across different CKD stages. The observed variations in muscle mass and physical capacity may influence physical activity, fatigue, and overall quality of life, which will be assessed using validated questionnaires. |