CTRI

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CTRI Number

CTRI/2025/05/086471 [Registered on: 07/05/2025] Trial Registered Prospectively

Last Modified On:

06/05/2025

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Correlation study

Study Design

Other

Public Title of Study

FRAILTY,FALL RISK AND PROTEIN ENERGY WASTING IN HEMODIALYSIS PATIENTS

Scientific Title of Study

RELATIONSHIP BETWEEN THE FRAILTY,FALL RISK AND PROTEIN ENERGY WASTING AMONG HEMODIALYSIS PATIENTS

Trial Acronym

Not applicable

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	NANCY EMELDA S
Designation	UG STUDENT
Affiliation	SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
Address	ROOM NO-PT 13,5TH FLOOR,SRM COLLEGE OF PHYSIOTHERAPY,SRM INSTITUTE OF SCIENCE AND TECHNOLOGY,KATTANKULATHUR,CHENGALPATTU,TAMILNADU Kancheepuram TAMIL NADU 603203 India
Phone	7708579541
Fax
Email	ns4732@srmist.edu.in

Details of Contact Person
Scientific Query

Name	KAVIYA M
Designation	ASSISTANT PROFESSOR
Affiliation	SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
Address	5TH FLOOR,SRM COLLEGE OF PHYSIOTHERAPY,SRM INSTITUTE OF SCIENCE&TECHNOLOGY,KATTANKULATHUR,CHENGALPATTU,TAMILNADU Kancheepuram TAMIL NADU 603203 India
Phone	9940513772
Fax
Email	kaviyam3@srmist.edu.in

Details of Contact Person
Public Query

Name	KAVIYA M
Designation	ASSISTANT PROFESSOR
Affiliation	SRM INSTITUTE OF SCIENCE AND TECHNOLOGY
Address	ROOM NO- ,5TH FLOOR, SRM COLLEGE OF PHYSIOTHERAPY,SRM INSTITUTE OF SCIENCE AND TECHNOLOGY,KATTANKULATHUR,CHENGALPATTU,TAMILNADU. Kancheepuram TAMIL NADU 603203 India
Phone	9940513772
Fax
Email	kaviyam3@srmist.edu.in

Source of Monetary or Material Support

SRM College of Physiotherapy,SRMIST,Kattankulathur,TAMILNADU,INDIA 603203

Primary Sponsor

Name	NANCY EMELDA S
Address	ROOM NO-PT 13,5TH FLOOR,SRM COLLEGE OF PHYSIOTHERAPY,SRM INSTITUTE OF SCIENCE &TECHNOLOGY,KATTANKULATHUR,CHENGALPATTU,TAMILNADU
Type of Sponsor	Other [SELF FUNDED]

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
Dr KAVIYA M	SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE	ROOM NO:4,5TH FLOOR,RENAL DIALYSIS CENTRE,SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,KATTANKULATHUR,CHENGALPATTU,TAMILNADU. Kancheepuram TAMIL NADU	9940513772 kaviyam3@srmist.edu.in

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: N19\|\|Unspecified kidney failure,

Intervention / Comparator Agent

Type	Name	Details
Intervention	NOT APPLICABLE	NOT APPLICABLE
Comparator Agent	NOT APPLICABLE	NOT APPLICABLE

Inclusion Criteria

Age From	18.00 Year(s)
Age To	80.00 Year(s)
Gender	Both
Details	The patients with chronic kidney disease(CKD),The male and female above 18 years,Patients undergoing haemodialysis for more than 3 months, The patient who have ability to understand the informed consent and sign it,Ambulating patients.

ExclusionCriteria

Details

Patients with any cognitive Impairment,
Patients whose recent medical records are unavailable,
Patients with disabilities other than CKD (Amputations, other balance disorders due to neurological impairment),
Patients involved in other clinical trials receiving experimental treatments that may affect outcomes,
Renal transplanted patients,
Patient undergoing peritoneal dialysis,
Any active Neoplastic or infectious disease.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
TO INVESTIGATE THE RELATIONSHIP BETWEEN THE FRAILTY,FALL RISK AND PROTEIN ENERGY WASTING(PEW) IN HEMODIALYSIS PATIENTS	8-12 weeks

Secondary Outcome

Outcome	TimePoints
TO EXPLORE THE ASSOCIATION OF DEMOGRAPHIC AND CLINICAL FACTORS SUCH AS AGE,GENDER,COMORBIDITIES WITH FRAILTY,FALL RISK AND PROTEIN ENERGY WASTING(PEW).	8-12 weeks

Target Sample Size

Total Sample Size="111"
Sample Size from India="111"
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)

17/05/2025

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="3"
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

The study will be proceeded after getting approval from the institutional ethical committee (IEC).Patients will be selected based on the inclusion and exclusion criteria .Informed consent will be obtained from the patients to ensure their willingness in this study.The need for the study will be clearly explained to the patients in their Regional language.The frailty will be assessed from the participants by asking the questions form the Edmonton frailty scale which is administered by the researcher.The person who’s score ranges from 8 to 17 is considered frail.The protein energy wasting will be assessed using the subjective global assessment.The nutritional status of the individual participants can be taken from the medical records.The fall risks for the CKD patients will be assessed using the fall risk assessment tool.