| CTRI Number |
CTRI/2022/09/046038 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
28/09/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA)
Other (Specify) [exercise interventions] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of exercise among patients with rheumatoid arthritis. |
|
Scientific Title of Study
|
Effectiveness of exercise interventions on upper limb function,range of motion,dexterity and grip strength 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 |
Suja JS |
| Designation |
Asst.Professor |
| Affiliation |
Govt.College of Nursing,Govt.Medical College,Thiruvananthapuram, |
| Address |
Asst.Professor,Govt.College of Nursing,Govt.Medical College,Thiruvananthapuram.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8281279802 |
| Fax |
|
| Email |
sujajs2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suja JS |
| Designation |
Asst.Professor |
| Affiliation |
Govt.College of Nursing,Govt.Medical College,Thiruvananthapuram, |
| Address |
Asst.Professor,Govt.College of Nursing,Govt.Medical College,Thiruvananthapuram.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8281279802 |
| Fax |
|
| Email |
sujajs2017@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suja JS |
| Designation |
Asst.Professor |
| Affiliation |
Govt.College of Nursing,Govt.Medical College,Thiruvananthapuram, |
| Address |
Asst.Professor,Govt.College of Nursing,Govt.Medical College,Thiruvananthapuram.
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8281279802 |
| Fax |
|
| Email |
sujajs2017@gmail.com |
|
|
Source of Monetary or Material Support
|
| No funding sought.
Setting- Govt.Medical College, Thiruvananthapuram
|
|
|
Primary Sponsor
|
| Name |
SujaJS |
| Address |
Asst.Professor,Govt.College of Nursing,Govt.Medical College,Thiruvananthapuram |
| 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 |
| SujaJS |
Govt.Medical College Hospital,Thiruvananthapuram |
Medicine and Rheumatology Out Patient Department.
Thiruvananthapuram
KERALA |
8281279802
sujajs2017@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Govt.College of Nursing,TVPM |
Approved |
| Govt.College of Nursing,TVPM |
Approved |
| SriRamachandra Institute of Higher education and Research,Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
exercise intervention |
Standard treatment + planned teaching and demonstration of exercises which include range of motion exercise(5mts),stretching exercise(5mts),strengthening exercise(5mts) and wrist curl exercise(5mts).exercise should begin with warm up phase of 5 mts and cool down phase of 5 mts.The total duration is 30 mts.Exercises should be done in morning and evening daily for 12 weeks.Pamphlets regarding the exercise and a grip strengthener also will be provided to the patients with rheumatoid arthritis.
|
| Comparator Agent |
Standard treatment given in the hospital |
medications prescribed by the doctor and advices given regarding the importance of taking medication and disease condition and follow up. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with rheumatoid arthritis who are
willing to participate in the study
2.Patients with rheumatoid arthritis who are in
functional class 1,II and III(American
college of rheumatology classification)
3.Patients with rheumatoid arthritis who are
able to follow english or malayalam
|
|
| ExclusionCriteria |
| Details |
1.Patients with rheumatoid arthritis who
underwent surgery in upper limb in the
previous six months
2.Patients with rheumatoid arthritis who
had intra-articular injection in upper limb
with in the previous four weeks
3.Patients with rheumatoid arthritis who had
fracture in upper limb in the previous
six months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| upper limb function,range of motion,dexterity and grip strength. |
baseline,4weeks,8 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No secondary outcome |
NA |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
15/10/2022 |
| 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="4"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Study is a randomized controlled trial with parallel arm assessing the effectiveness of exercise interventions on upper limb function,range of motion,dexterity and grip strength among patients with rheumatoid arthritis attending medicine and rheumatology OPD,Medical College Hospital,Thiruvananthapuram. The experimental group will be recieving the standard treatment + teaching and demonstration of exercise (range of motion,stretching,strengthening and wrist curl exrecises).pamphlets regarding the exercise and a grip strengthener also will be provided.Control group will be recieving only the standard treatment. Outcome measures include upper limb function,range of motion,dexterity and grip strength and assessed by Michigan hand outcome questionnaire,goniometer,nine hole peg test and hand dynamometer respectively. Assessment will be done at baseline,4 weeks,8 weeks and 12 weeks. |