| CTRI Number |
CTRI/2025/11/096939 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Link Between Physical Fitness, Flexibility, and Fear of Movement in Dialysis Patients |
|
Scientific Title of Study
|
Association of Functional Capacity and Flexibility to Kinesiophobia Among Patients with Kidney Disease Undergoing Haemodialysis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lasima |
| Designation |
Post Graduate Student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
MPT Division, Physiotherapy Department, Yenepoya Physiotherapy College, Naringana, Deralakatte, Mangaluru - 575018, Dakshina kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9946950582 |
| Fax |
|
| Email |
lasimamanafvm@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nigat Fathima |
| Designation |
Associate professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Staff Division, Physiotherapy Department, Yenepoya Physiotherapy College
Naringana, Deralakatte, Mangaluru - 575018, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7406225106 |
| Fax |
|
| Email |
fathimanigat@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Lasima |
| Designation |
Post Graduate Student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
MPT Division, Physiotherapy Department, Yenepoya Physiotherapy College, Naringana, Deralakatte, Mangaluru - 575018, Dakshina kannada, Karnataka, India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9946950582 |
| Fax |
|
| Email |
lasimamanafvm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College
Naringana, Deralakatte, Mangaluru - 575018, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Lasima |
| Address |
6th floor, Physiotherapy Department, Yenepoya Physiotherapy College
Naringana, Deralakatte, Mangaluru - 575018, Karnataka, India |
| 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 Nigat Fathima PT |
Yenepoya Medical College |
7th floor, Physiotherapy department, Deralakatte, Dakshina Kannada, Mangalure-575018, Karnataka, India
Dakshina Kannada
KARNATAKA |
7406225106
fathimanigat@yenepoya.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committe-3 (YEC-3) |
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 |
85.00 Year(s) |
| Gender |
Both |
| Details |
a) Patients diagnosed with CKD (stage 3-4)
b) Age greater than 18 years irrespective of gender
c) Patients who possess complete cognition, understanding and communication skills
d) Independent exercise capacity.
|
|
| ExclusionCriteria |
| Details |
a) Patients with active malignant tumours
b) Contraindication to exercise
c) Severe anaemia
d) Uncontrolled cardiovascular disease
e) Recent fractures or any orthopaedic conditions
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Kinesiophobia
|
At baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Functional capacity
2. Flexibility |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
16/11/2025 |
| 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="2"
Months="0"
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
|
This cross-sectional observational study aims to assess the association of functional capacity and flexibility to kinesiophobia among patients with kidney disease undergoing hemodialysis. Functional capacity will be measured using the 6-minute-walk test (6MWT), and flexibility will be assessed using V-sit-and-reach test. Kinesiophobia will be evaluated using the Modified version of Tampa Scale of Kinesiophobia-11 (TSK-11). Data will be collected at a single point in time, during the enrolment time of the study. The primary outcome of the study if Kinesiophobia, while the secondary outcomes include functional capacity and flexibility. This study will help in understanding how kinesiophobia has an effect on declining physical factors like functional capacity and flexibility in patients undergoing hemodialysis. Which will help in modification and generation of an individualised exercise protocol for the same patient category addressing kinesiophobia as well in the future studies. |