OsteoarthritisPEPOA-ENCT01119547
Patient Education Program for Osteoarthritis With Exercise Included
A study testing Exercise in a group and Home exercise in people with Osteoarthritis, run by Lund University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Exercise in a group and Home exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2010to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical diagnosis of osteoarthritis
Who cannot join
- Must be able to speak and understand swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Including Exercise in an Education Program for Patients With Osteoarthritis in Primary Health Care
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Exercise in a group, Home exercise
- Keywords
- Musculoskeletal Diseases, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
- Medical subject headings
- Osteoarthritis, Musculoskeletal Diseases, Joint Diseases, Arthritis, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise in a groupOther
The patient do their individual exercise program in a group.
Home exerciseOther
The patient exercise their individual program at home during 6 v.
| Study group | Role | What they receive |
|---|---|---|
| Home exercise | Experimental | The patients is training at home during 6 v. with an individual exercise program. Receives: Other: Home exercise |
| Exercise in group | Experimental | The patients is doing their individual exercise program in a group. Receives: Other: Exercise in a group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arthritis self-efficacy scale
Measure the patients self-efficacy
Measured: at baseline
One-leg rising from sitting to standing
measure the strength
Measured: at baseline
Grip Ability Test
Measure function of the hand
Measured: at baseline
QuickDash
Measure self-percieved function of the arm/hand
Measured: at baseline
Arthritis self-efficacy scale
Measure the patients self-efficacy
Measured: after 4 month
One leg rising from sitting to standing
measure the strength
Measured: after 4 month
Grip Ability Test
Measure function of the hand
Measured: after 4 month
QuickDash
Measure self-percieved function of the arm/hand
Measured: after 4 month
Secondary outcomes (12)
Bipedal rising from sitting to standing
Measure the strength
Measured: at baseline
One-legged jump
measure strength and balance
Measured: at baseline
Standing on one leg with eyes open and standing on one leg with eyes closed
Measure the balance
Measured: at baseline
Jamar
Measure the handstrength
Measured: at baseline
PinchGauge
Measure the fingers strength
Measured: at baseline
EQ5D
Measure self-percieved health
Measured: at baseline
Bipedal rising from sitting to standing
measure the strength
Measured: after 4 month
One-legged jump
measure strength and balance
Measured: after 4 month
Standing on one leg with eyes open and standing on one leg with eyes closed
measure the balance
Measured: after 4 month
Jamar
Measure the handstrength
Measured: after 4 month
PinchGauge
Measure the fingers strength
Measured: after 4 month
EQ5D
Measure self-percieved health
Measured: after 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2010 (estimated)
- Study startSep 2010
- Primary completionSep 2012 (estimated)
- Study completionSep 2012 (estimated)
Why it stopped: Investigator no longer at LU.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Malin Jönsson Lundgren, RPT, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119547
- Sponsor's protocol ID
- PEPOA-E
- Acronym
- PEPOA-E
- Status last verified
- Apr 2010
- First submitted
- 29 Apr 2010
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Including Exercise in an Education Program for Patients With Osteoarthritis in Primary Health Care
- ClinicalTrials.gov ID
- NCT01119547
- Acronym / sponsor ID
- PEPOA-E / PEPOA-E
- Conditions
- Osteoarthritis
- Keywords
- Musculoskeletal Diseases, Osteoarthritis, Joint Diseases, Arthritis, Rheumatic Diseases
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator no longer at LU.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2012 (estimated)
- Study completion
- Sep 2012 (estimated)
- First posted
- 7 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Home exercise | Experimental | Other: Home exerciseThe patients is training at home during 6 v. with an individual exercise program. |
| Exercise in group | Experimental | Other: Exercise in a groupThe patients is doing their individual exercise program in a group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of osteoarthritis
Key exclusion criteria (1 listed)
- Must be able to speak and understand swedish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise in a groupThe patient do their individual exercise program in a group. | Other | Exercise in group |
| Home exerciseThe patient exercise their individual program at home during 6 v. | Other | Home exercise |
Primary outcome
Arthritis self-efficacy scale
Time frame: at baseline
Measure the patients self-efficacy
One-leg rising from sitting to standing
Time frame: at baseline
measure the strength
Grip Ability Test
Time frame: at baseline
Measure function of the hand
QuickDash
Time frame: at baseline
Measure self-percieved function of the arm/hand
Arthritis self-efficacy scale
Time frame: after 4 month
Measure the patients self-efficacy
One leg rising from sitting to standing
Time frame: after 4 month
measure the strength
Grip Ability Test
Time frame: after 4 month
Measure function of the hand
QuickDash
Time frame: after 4 month
Measure self-percieved function of the arm/hand
12 secondary outcomes
Bipedal rising from sitting to standing
Time frame: at baseline
One-legged jump
Time frame: at baseline
Standing on one leg with eyes open and standing on one leg with eyes closed
Time frame: at baseline
Jamar
Time frame: at baseline
PinchGauge
Time frame: at baseline
EQ5D
Time frame: at baseline
Bipedal rising from sitting to standing
Time frame: after 4 month
One-legged jump
Time frame: after 4 month
Standing on one leg with eyes open and standing on one leg with eyes closed
Time frame: after 4 month
Jamar
Time frame: after 4 month
PinchGauge
Time frame: after 4 month
EQ5D
Time frame: after 4 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malin Jönsson Lundgren, RPT principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in a group and Home exercise in people with Osteoarthritis, run by Lund University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arthritis self-efficacy scale (time frame: at baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2018.