| CTRI Number |
CTRI/2025/03/083449 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Muscle fatigue patterns in CKD population |
|
Scientific Title of Study
|
Lower extremity muscle fatigue characteristics in patients with chronic kidney disease undergoing hemodialysis and conservative treatment : A comparative cross sectional 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 |
Vinitha Arasu |
| Designation |
Post graduate student |
| Affiliation |
SRM Institute of Science and technology |
| Address |
Room No: PT 20, IV Floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8637488187 |
| Fax |
|
| Email |
vinithabks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sowmiya.M |
| Designation |
Assistant Professor |
| Affiliation |
SRM Institute of Science and technology |
| Address |
Room No: PT 10, V Floor, Experts paradise, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
6369290837 |
| Fax |
|
| Email |
sowmiyam1@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Vinitha Arasu |
| Designation |
Post graduate student |
| Affiliation |
SRM Institute of Science and technology |
| Address |
Room No: PT 20, IV Floor, SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8637488187 |
| Fax |
|
| Email |
vinithabks@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy,SRM Institute of Science and technology,Kattankulathur,
Tamil Nadu,India -603 203 |
|
|
Primary Sponsor
|
| Name |
Vinitha Arasu |
| Address |
Room No-PT20,SRM College of Physiotherapy, SRM Medical College Hospital and Research Centre, SRM Institute of Science and Technology, Kattankulathur,Tamil Nadu,India-603 203 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| DrVinitha Arasu |
SRM Medical College Hospital and Research Centre |
Room no- G10, V Floor, Department of Nephrology, SRM Medical College Hospital and Research Centre,SRM Institute of science and technology, Kattankulathur,Tamil Nadu,India-603 203
Kancheepuram
TAMIL NADU |
8637488187
vinithabks@gmail.com |
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N183||Chronic kidney disease, stage 3 (moderate), |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Medically diagnosed patients of moderate to severe CKD (Stage 3a -5)
Self reported fatigue symptoms using FACIT - F (Scores 30 or less)
|
|
| ExclusionCriteria |
| Details |
Severe cognitive impairments
Severe neurological diseases, Amputation,
Acute kidney disease,
Those with orthopedic implant in the lower limb,
Uncontrolled hypertension at rest,
OA and RA of Lower extremity joints,
Skin conditions that may not permit placement of surface electrodes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
EMG indices of Mean power frequency and median frequency
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Self reported fatigue questionnaire FACIT-F
Functional Assessment of Chronic Illness Therapy-Fatigue
|
Baseline |
|
|
Target Sample Size
|
Total Sample Size="384"
Sample Size from India="384"
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)
|
05/04/2025 |
| 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="9"
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
|
Informed written consent will be obtained from all the potential participants in regional language. Eligible participants will be administered with 13 items self- reported FACIT-F questionnaire (Functional Assessment of Chronic Illness therapy -Fatigue). Participant’s with scores 30 or less in FACIT-F is considered to have a severe fatigue symptoms. Selected participants will be taken for EMG fatigue analysis. Cardiologist and Nephrologist clearance will be taken before exposing them to fatigue protocol in order to ensure the safety of the CKD Patients. Participants will be clearly familiarized with the procedures of EMG before starting the protocol. The surface EMG electrodes and sensors will be placed over bilateral Vastus medialis and Medial head of gastrocnemius based on the SENIAM guidelines. Participants will be asked to perform the paced sit to stand protocol as per guidelines.
Procedures of Paced sit to stand Protocol:
Participants will be asked to be seated in 45 cm height chair or stool without the armrest. They will be asked to perform stand to sit in a chair repeatedly. The frequency of the sit to stand will be controlled by metronome (30 cycles /minute).The fatigue protocol will be stopped when one of the following conditions are met; When the participant indicate their inability to continue, the movement frequency fall below and remain below 30 cycles/ min after encouragement, or after 30 min.
|