| CTRI Number |
CTRI/2025/07/090717 [Registered on: 11/07/2025] Trial Registered Prospectively |
| Last Modified On: |
09/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Fatigue Levels in Kidney Disease Patients Before and After Dialysis: A Cross-Sectional Study |
|
Scientific Title of Study
|
Fatigue Severity Before and After Hemo-Dialysis in Chronic Kidney Disease Patients: Cross- Sectional observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pragati Joshi |
| Designation |
Postgraduate student |
| Affiliation |
Datta Megha college of Physiotherapy, Nagpur |
| Address |
Department of cardiovascular and Respiratory Physiotherapy, Datta Megha college of Physiotherapy, Shri Datta Megha Polytechnic Campus Wanadongri, Hingna Road,Nagpur 441110 MAHARASHTRA India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9623010721 |
| Fax |
|
| Email |
jpragati143@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manish P Shukla |
| Designation |
Professor |
| Affiliation |
Datta Megha college of Physiotherapy, Nagpur |
| Address |
Department of cardiovascular and Respiratory Physiotherapy, Datta Megha college of Physiotherapy, Shri Datta Megha Polytechnic Campus Wanadongri, Hingna Road,Nagpur 441110 MAHARASHTRA India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9960290614 |
| Fax |
|
| Email |
manish.shukla20@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pragati Joshi |
| Designation |
Postgraduate student |
| Affiliation |
Datta Megha college of Physiotherapy, Nagpur |
| Address |
Department of cardiovascular and Respiratory Physiotherapy, Datta Megha college of Physiotherapy, Shri Datta Megha Polytechnic Campus Wanadongri, Hingna Road,Nagpur 441110 MAHARASHTRA India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
441110 |
| Fax |
|
| Email |
jpragati143@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Babasaheb Ambedkar Superspeciality Institute,Wanadongri, Hingna Road, Nagpur 441110 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Datta Megha college of Physiotherapy |
| Address |
Shri Datta Meghe Polytechnic Campus Wanadongri,Hingna Road,Nagpur 441110 MAHARASHTRA India |
| 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 |
| Dr Pragati Pandharinath Joshi |
Dr Babasaheb Ambedkar Superspeciality institute,Wanadongri Nagpur |
Department of Nephrology, ward no 19 Dr Babasaheb Ambedkar Superspeciality institute,Wanadongri Nagpur
Nagpur
MAHARASHTRA |
9623010721
jpragati143@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe College of Physiotherapy, BORS COMMITTEE |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with chronic kidney disease on regular hemodialysis for at least three months.
Diagnosed with chronic kidney disease and undergoing maintenance hemodialysis for at least three months.
Receiving twice or thrice-weekly hemodialysis at a dialysis center.
Able to understand and respond to fatigue assessment tools (e.g., Fatigue Severity scale) |
|
| ExclusionCriteria |
| Details |
Patients with cognitive impairments, psychiatric illness, or acute infections were excluded.
Acute kidney injury (AKI) or recent initiation of dialysis (less than 3 months).
Patients with active infections, malignancy, or hospitalization in the past 30 days.
Those receiving peritoneal dialysis or other renal replacement therapies.
Use of medications known to cause fatigue like sedatives, high-dose opioids) that could confound results.
Patients with untreated anemia Hb less than 8 g/dLor active gastrointestinal bleeding. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fatigue severity scale ( FSS) |
Within 30 minutes before hemo dialysis and within 30 minutes after dialysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Rate of Perceived Exertion (RPE) |
Within 30 minutes before hemo dialysis and within 30 minutes after dialysis |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
21/07/2025 |
| 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="6"
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
|
The study will examine fatigue severity before and after hemodialysis in patients diagnosed with chronic kidney disease. Researchers will conduct a cross-sectional analysis involving adult participants undergoing maintenance hemodialysis. Fatigue levels will be measured using a standardized fatigue assessment scale administered prior to and immediately after the dialysis session. The data will be analyzed to identify any significant differences in fatigue scores pre- and post-treatment. The study will also explore potential factors that will influence fatigue, such as duration of dialysis, age, gender, and comorbid conditions. Results will provide insights into how hemodialysis sessions will impact physical and mental fatigue in this population. The findings will help healthcare providers understand the severity and pattern of fatigue associated with dialysis and will inform interventions that will aim to reduce fatigue and improve patients’ quality of life. Recommendations will be developed to guide supportive care practices in dialysis centers |