Back to resultsA Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Siriraj knee exercise
Physical modalities
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Home base exercise
Eligibility Criteria
Inclusion Criteria:
- 1st osteoarthritis of the knee Age >/= 50 yrs
Exclusion Criteria:
- Previous knee surgery for OA knee treatment
- Has plan or schedule for knee surgery
- Severe degree of OA knee.
Sites / Locations
- Siriraj hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
usual care
Siriraj home base exercise
Modalities and exercise
Arm Description
quadricep exercise
Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise
Physical modalities for 6 weeks and Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise
Outcomes
Primary Outcome Measures
WOMAC score
Secondary Outcome Measures
6 mins walk test
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02600702
Brief Title
A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee
Official Title
A Randomized Control Study of Siriraj Home Exercises Protocol for Primary Knee Osteoarthritis Patients Versus Usual Orthopedic Outpatient Consultation in Primary Knee Osteoarthritis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to compare the exercise protocol called "Siriraj home base exercise program for OA knee" to usual care and physical modalities for conservative treatment in patients with 1st OA knee.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Home base exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
usual care
Arm Type
No Intervention
Arm Description
quadricep exercise
Arm Title
Siriraj home base exercise
Arm Type
Experimental
Arm Description
Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise
Arm Title
Modalities and exercise
Arm Type
Active Comparator
Arm Description
Physical modalities for 6 weeks and Knee exercise protocol for 12 position for 3 months with low-impact aerobic exercise
Intervention Type
Other
Intervention Name(s)
Siriraj knee exercise
Intervention Description
Siriraj knee exercise, 12 position of exercise protocol
Intervention Type
Other
Intervention Name(s)
Physical modalities
Primary Outcome Measure Information:
Title
WOMAC score
Time Frame
3 months
Secondary Outcome Measure Information:
Title
6 mins walk test
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1st osteoarthritis of the knee Age >/= 50 yrs
Exclusion Criteria:
Previous knee surgery for OA knee treatment
Has plan or schedule for knee surgery
Severe degree of OA knee.
Facility Information:
Facility Name
Siriraj hospital
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
A Study of Siriraj Home Exercises Protocol for Primary Osteoarthritis of the Knee
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