- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01119547
Patient Education Program for Osteoarthritis With Exercise Included (PEPOA-E)
The Effect of Including Exercise in an Education Program for Patients With Osteoarthritis in Primary Health Care
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Osteoarthritis (OA) is a degenerative disease, considered to be one of the major national diseases that cause suffering for affected patients and costs for society.The predominant symptoms are pain, stiffness and impaired quality of life, often together with psychological distress. Treatment often consists of medication. Later in the disease, when the joint is destroyed, joint replacement surgery commonly occurs. Physical exercises aimed to increase muscle strength, endurance, proprioception and stability have proved to influence cartilage as well as function, symptoms and quality of life positively. Physical exercise may also reduce the need for hospital care after knee joint replacement.Research suggests that patient education is feasible and valuable in terms of improvements in quality of life, in function, in well-being and improved coping . Accordingly, guidelines recommend education and exercise as a core treatment for osteoarthritis.
Since 1994, Primary Health Care in Malmö has used a patient education programme directed towards OA.The program does not include exercise. In 2007-09 a study was made to investigate this education program.The study showed improvements in self-perceived health and in a few functional tests but not in self-efficacy.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Skåne
-
Malmö, Skåne, Sweden, 205 02
- Primary Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Clinical diagnosis of osteoarthritis
Exclusion Criteria:
- Must be able to speak and understand swedish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home exercise
The patients is training at home during 6 v. with an individual exercise program.
|
The patient exercise their individual program at home during 6 v.
|
|
Experimental: Exercise in group
The patients is doing their individual exercise program in a group.
|
The patient do their individual exercise program in a group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arthritis self-efficacy scale
Time Frame: at baseline
|
Measure the patients self-efficacy
|
at baseline
|
|
One-leg rising from sitting to standing
Time Frame: at baseline
|
measure the strength
|
at baseline
|
|
Grip Ability Test
Time Frame: at baseline
|
Measure function of the hand
|
at baseline
|
|
QuickDash
Time Frame: at baseline
|
Measure self-percieved function of the arm/hand
|
at baseline
|
|
Arthritis self-efficacy scale
Time Frame: after 4 month
|
Measure the patients self-efficacy
|
after 4 month
|
|
One leg rising from sitting to standing
Time Frame: after 4 month
|
measure the strength
|
after 4 month
|
|
Grip Ability Test
Time Frame: after 4 month
|
Measure function of the hand
|
after 4 month
|
|
QuickDash
Time Frame: after 4 month
|
Measure self-percieved function of the arm/hand
|
after 4 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bipedal rising from sitting to standing
Time Frame: at baseline
|
Measure the strength
|
at baseline
|
|
One-legged jump
Time Frame: at baseline
|
measure strength and balance
|
at baseline
|
|
Standing on one leg with eyes open and standing on one leg with eyes closed
Time Frame: at baseline
|
Measure the balance
|
at baseline
|
|
Jamar
Time Frame: at baseline
|
Measure the handstrength
|
at baseline
|
|
PinchGauge
Time Frame: at baseline
|
Measure the fingers strength
|
at baseline
|
|
EQ5D
Time Frame: at baseline
|
Measure self-percieved health
|
at baseline
|
|
Bipedal rising from sitting to standing
Time Frame: after 4 month
|
measure the strength
|
after 4 month
|
|
One-legged jump
Time Frame: after 4 month
|
measure strength and balance
|
after 4 month
|
|
Standing on one leg with eyes open and standing on one leg with eyes closed
Time Frame: after 4 month
|
measure the balance
|
after 4 month
|
|
Jamar
Time Frame: after 4 month
|
Measure the handstrength
|
after 4 month
|
|
PinchGauge
Time Frame: after 4 month
|
Measure the fingers strength
|
after 4 month
|
|
EQ5D
Time Frame: after 4 month
|
Measure self-percieved health
|
after 4 month
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Malin Jönsson Lundgren, RPT, Lund University
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PEPOA-E
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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