Patient Education Program for Osteoarthritis With Exercise Included (PEPOA-E)
Primary Purpose
Osteoarthritis
Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Exercise in a group
Home exercise
Sponsored by

About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring Musculoskeletal Diseases, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of osteoarthritis
Exclusion Criteria:
- Must be able to speak and understand swedish
Sites / Locations
- Primary Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Home exercise
Exercise in group
Arm Description
The patients is training at home during 6 v. with an individual exercise program.
The patients is doing their individual exercise program in a group.
Outcomes
Primary Outcome Measures
Arthritis self-efficacy scale
Measure the patients self-efficacy
One-leg rising from sitting to standing
measure the strength
Grip Ability Test
Measure function of the hand
QuickDash
Measure self-percieved function of the arm/hand
Arthritis self-efficacy scale
Measure the patients self-efficacy
One leg rising from sitting to standing
measure the strength
Grip Ability Test
Measure function of the hand
QuickDash
Measure self-percieved function of the arm/hand
Secondary Outcome Measures
Bipedal rising from sitting to standing
Measure the strength
One-legged jump
measure strength and balance
Standing on one leg with eyes open and standing on one leg with eyes closed
Measure the balance
Jamar
Measure the handstrength
PinchGauge
Measure the fingers strength
EQ5D
Measure self-percieved health
Bipedal rising from sitting to standing
measure the strength
One-legged jump
measure strength and balance
Standing on one leg with eyes open and standing on one leg with eyes closed
measure the balance
Jamar
Measure the handstrength
PinchGauge
Measure the fingers strength
EQ5D
Measure self-percieved health
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119547
Brief Title
Patient Education Program for Osteoarthritis With Exercise Included
Acronym
PEPOA-E
Official Title
The Effect of Including Exercise in an Education Program for Patients With Osteoarthritis in Primary Health Care
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator no longer at LU.
Study Start Date
September 2010 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lund University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to investigate if inclusion of exercise in an education program for patients with osteoarthritis can improve self efficacy, self-perceived health and function.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Musculoskeletal Diseases, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Home exercise
Arm Type
Experimental
Arm Description
The patients is training at home during 6 v. with an individual exercise program.
Arm Title
Exercise in group
Arm Type
Experimental
Arm Description
The patients is doing their individual exercise program in a group.
Intervention Type
Other
Intervention Name(s)
Exercise in a group
Intervention Description
The patient do their individual exercise program in a group.
Intervention Type
Other
Intervention Name(s)
Home exercise
Intervention Description
The patient exercise their individual program at home during 6 v.
Primary Outcome Measure Information:
Title
Arthritis self-efficacy scale
Description
Measure the patients self-efficacy
Time Frame
at baseline
Title
One-leg rising from sitting to standing
Description
measure the strength
Time Frame
at baseline
Title
Grip Ability Test
Description
Measure function of the hand
Time Frame
at baseline
Title
QuickDash
Description
Measure self-percieved function of the arm/hand
Time Frame
at baseline
Title
Arthritis self-efficacy scale
Description
Measure the patients self-efficacy
Time Frame
after 4 month
Title
One leg rising from sitting to standing
Description
measure the strength
Time Frame
after 4 month
Title
Grip Ability Test
Description
Measure function of the hand
Time Frame
after 4 month
Title
QuickDash
Description
Measure self-percieved function of the arm/hand
Time Frame
after 4 month
Secondary Outcome Measure Information:
Title
Bipedal rising from sitting to standing
Description
Measure the strength
Time Frame
at baseline
Title
One-legged jump
Description
measure strength and balance
Time Frame
at baseline
Title
Standing on one leg with eyes open and standing on one leg with eyes closed
Description
Measure the balance
Time Frame
at baseline
Title
Jamar
Description
Measure the handstrength
Time Frame
at baseline
Title
PinchGauge
Description
Measure the fingers strength
Time Frame
at baseline
Title
EQ5D
Description
Measure self-percieved health
Time Frame
at baseline
Title
Bipedal rising from sitting to standing
Description
measure the strength
Time Frame
after 4 month
Title
One-legged jump
Description
measure strength and balance
Time Frame
after 4 month
Title
Standing on one leg with eyes open and standing on one leg with eyes closed
Description
measure the balance
Time Frame
after 4 month
Title
Jamar
Description
Measure the handstrength
Time Frame
after 4 month
Title
PinchGauge
Description
Measure the fingers strength
Time Frame
after 4 month
Title
EQ5D
Description
Measure self-percieved health
Time Frame
after 4 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of osteoarthritis
Exclusion Criteria:
Must be able to speak and understand swedish
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malin Jönsson Lundgren, RPT
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Health Care
City
Malmö
State/Province
Skåne
ZIP/Postal Code
205 02
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Patient Education Program for Osteoarthritis With Exercise Included
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