| CTRI Number |
CTRI/2024/12/078147 [Registered on: 16/12/2024] Trial Registered Prospectively |
| Last Modified On: |
13/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Corelation among physical fitness, mental abilities, quality of living and coping skills in older adults with rheumatoid arthritis |
|
Scientific Title of Study
|
Association of Physical fitness, Cognitive function, Quality of life and Coping strategies in Elderly with Rheumatoid Arthritis: An 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 |
Dr Anil Muragod |
| Designation |
Professor and HOD of Geriatric Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLE Institute of physiotherapy, room no 21, research lab unit J.N.Medical college campus, nehru nagar, Belagavi, Karntaka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmuragod@klekipt.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Muragod |
| Designation |
Professor and HOD of Geriatric Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLE Institute of physiotherapy, room no 21 research unit lab J.N.Medical college campus, nehru nagar, Belagavi Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmuragod@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DrAnil Muragod |
| Designation |
Professor and HOD of Geriatric Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
KLE Institute of physiotherapy, J.N.Medical college campus, nehru nagar, Belgaum.
KARNATAKA
590010
India |
| Phone |
08312473906 |
| Fax |
|
| Email |
anilmuragod@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| K.L.Es Dr. Prabhakar Kore Hospital and research centre. |
| Uppin Multi speciality hospital and Arthritis Centre, Sadashiv nagar, Belgaum. |
|
|
Primary Sponsor
|
| Name |
Esha Baliga |
| Address |
KLE Institute of Physiotherapy, J. N Medical college campus, Nehru nagar, Belgaum. 590010 |
| Type of Sponsor |
Other [Self sponsored project] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Edna Monteiro |
KLE Institute of physiotherapy,J.N. Mediacl college campus, Nehru nagar, Belagavi. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anil Muragod |
KLEs Dr. Prabhakar Kore Hospital & Medical Research Centre |
Department of Orthopaedics, OPD No.2 , Division of clinical rheumatology and immunology, KLE Hospital,Front Entrance, NH Service Road, Nehru Nagar, Belagavi, Karnataka 590010
Belgaum
KARNATAKA |
08312473906
anilmuragod@klekipt.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KLE INSTITUTE OF PHYSIOTHERAPY RESEARCH AND ETHICS COMMITTEE |
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
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Both male and female aged 60-80 years
2.Diagnosed cases of rheumatoid arthritis for past 10 years
3.Individuals who can walk independently with or without a walking aid and can complete 8m gait test.
|
|
| ExclusionCriteria |
| Details |
1.Medically unfit patients(Patients with fractures in last one to two year, cardiac conditions, respiratory conditions, neurological conditions and psychiatric impairments)
2.Individuals with severe pain according to the Visual analogue scale(7.5 and above)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to determine association of physical fitness, cognitive function and quality of life in elderly with rheumatoid arthritis |
one time approach no follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine whether coping mechanisms are used by elderly people with rheumatoid arthritis |
one time study with no follow up |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2024 |
| Date of Study Completion (India) |
15/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
·
Prior
to the commencement of the study, an Ethical Clearance will be obtained by the
Institutional Ethical Committee.
·
The
participants will be selected on the basis of inclusion and exclusion criteria.
·
Subjects
will be briefed about the purpose of the study.
· A written informed consent will be taken from the
participants and those consenting to participate in the study will be tested for physical fitness
For Endurance by 2 min step
test
The subject stands next to a wall, examiner
marks the wall at level of knee-hip midpoint, subject march in place for 2
minutes lifting knees to the mark, resting and holding onto something is
allowed. The times the right knee crosses the mark
is calculated and the result for this test is obtained.
For Upper limb flexibility by Back scratch test
The subject is told to reach one hand behind the head, then
back over the shoulder, reaching as down to the center of the back as possible and one hand from the lower end of the back as up as possible, both the
middle fingers have to be centrally placed. The gap between the tips of the subject’s fingers should be measured.
If the fingertips touch, the score is zero; if they don’t, find the difference
between the tips of the fingers (negative); if they overlap, measure how much.
For Lower limb flexibility
by Chair sit and reach test
The subject is instructed to sit at the
front edge of the chair, extend one leg, and place one hand on top of the other
with fingertips reaching towards toe of the extended
leg, keeping back straight and head up. The patient should try to touch their toes with their fingertips, the
distance between the fingertips and toes has to be measured.
For Balance by Timed up and
Go Test.
The TUG test records the time it takes
a patient to rise from a chair, mobilize 3 meters[18] turn through 180 degrees,
return to the chair and sit down, walking aids can be used if required.
Cognition will be assessed by MONTREAL COGNITIVE ASSESMENT SCALE
The test includes 12 sub-tasks that assess different
cognitive domains, such as attention,
memory, language, and orientation. The test is scored on a scale of 0–30
points, with a score of 26 or higher considered normal.
Quality of life will be assessed by SF12 QUESTIONNAIRE
The SF-12 was
developed by selecting 12 items of the SF-36 to have a short
HRQoL questionnaire.
The SF-12 has
two scores: the physical health component score (PCS) and the mental health
component score (MCS). The PCS measures physical functioning, bodily pain, and
general health. The MCS evaluates vitality, social functioning, role-emotional,
and mental health. An individual’s total or composite score is determined by
taking an average of the two scores.
BRIEF COPE QUESTIONNAIRE
Is a 28 item self-reporting questionnaire. Answers are
divided into 4 options. Scores are presented as average scores by dividing sum
of item scores by by number of items
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