| CTRI Number |
CTRI/2020/11/028816 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
14/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To find out if fear of movement, the capacity to do day to day activities and self perception of ones health are related in Rheumatoid arthritis patients. |
|
Scientific Title of Study
|
Relationship between Kinesiophobia,Quantitative functional capacity and Self-perception of health among patients with Rheumatoid arthritis |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Manasi Lotankar |
| Designation |
Post Graduate student |
| Affiliation |
Sancheti Institue College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy , Musculoskeletal department 12 Thube Park Shivajinagar , Pune
Sancheti Institute for Orthopaedics and Rehabilitation, 16, Shivajinagar , Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9930762688 |
| Fax |
|
| Email |
manasilotankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nilima Bedekar |
| Designation |
HOD Musculoskeletal Department |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy , Musculoskeletal Department, 12 Thube Park Shivajinagar , Pune
Sancheti Institute for Orthopaedics and Rehabilitation,16, Shivajinagar,Pune
411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9420861882 |
| Fax |
|
| Email |
nssbedekar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasi Lotankar |
| Designation |
Post Graduate student |
| Affiliation |
Sancheti Institute College of Physiotherapy |
| Address |
Sancheti Institute College of Physiotherapy , Musculoskeletal Department, 12 Thube Park Shivajinagar , Pune
Sancheti Institute for Orthopaedics and Rehabilitation , 16 , Shivajinagar, Pune 411005
Pune
MAHARASHTRA
411005
India |
| Phone |
9930762688 |
| Fax |
|
| Email |
manasilotankar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sancheti Hospital for Orthopaedics and Rehabilitation |
|
|
Primary Sponsor
|
| Name |
Sancheti Institute college of physiotherapy |
| Address |
Sancheti Institute College of physiotherapy 12 Thube Park Shivajinagar Pune 411005 |
| Type of Sponsor |
Private medical college |
|
|
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 Manasi Lotankar |
Sancheti Hospital for Orthopaedics and Rehabilitation |
16,Floor -1, Department of Musculoskeletal physiotherapy, Shivajinagar Pune
Pune
MAHARASHTRA |
9930762688
manasilotankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Sancheti Institute for Orthopaedics and Rehabilitation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M059||Rheumatoid arthritis with rheumatoid factor, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with definitive Rheumatoid arthritis by a rheumatologist
|
|
| ExclusionCriteria |
| Details |
Patients undergone recent surgery
Unstable angina during previous month
Recent acute MI
Recent exacerbation or high disease activity
Patients undergone TKR surgery
Systolic B.P > 180 and/or Diastolic BP >100 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Self perception of health via the HAQ II Questionnaire
Quantitative functional capacity via
30 sec chair stand test
Grip strength measurement
6 min walk distance
Timed up and Go test |
assessed at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Kinesiophobia via the TSK 11 scale |
assessed at baseline |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
Final Enrollment numbers achieved (Total)= "41"
Final Enrollment numbers achieved (India)="41" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2020 |
| Date of Study Completion (India) |
15/10/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a correlational cross sectional study that finds the relationship between kinesiophobia that is assessed by the TSK 11 scale , self perception of health assessed by the HAQ II Questionnaire and Quantitative functional capacity assessed by 4 objective tests - 30 sec chair stand test , Grip strength measurement done by a sphygmomanometer, 6 min walk distance and Timed up and go. The study is a one time assessment done on patients with Rheumatoid arthritis.Patients will fill the TSK 11 and HAQ II questionnaires, after which they will be asked to perform the 4 objective tests . The TSK 11 score will then be correlated with the HAQ II scores and the objective test measures. The objective test measures will also be correlated with the self perception of health (HAQ II scores.) |