OsteoarthritisNCT02022566
Effect of Structured Info and Adapted Exercise in OA
A study testing A supported self management of osteoarthritis program in people with Osteoarthritis, run by Lund University at 1 site in Sweden.
Trial summary
Physical activity level is measured at baseline and after 3 and 12 months after structured information and individually adapted exercise for patients with osteoarthritis in hip or knee. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- A supported self management of osteoarthritis program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 317 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2009to Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years old.
- Patients with clinically verified OA, coming to see a physical therapist for the Supported self-management of osteoarthritis program.
Who cannot join
- Other serious disorders causing hip or knee pain (e.g. tumor, rheumatic arthritis, sequel hip fracture).
- Other symptoms more aggravating than the OA problem (e.g. chronic pain, fibromyalgia, cardio-respiratory dysfunction, spinal condition).
- Total joint replacement surgery within the past 12 months.
- Other surgery of knee or hip within the past 3 months.
- Unable to read and understand Swedish and follow verbal and visual instructions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Structured Information and Individually Adapted Exercise on Levels of Physical Activity Measured by Accelerometer in Patients With Knee or Hip Osteoarthritis - an Observational Study With Control Group.
Physical activity level is measured at baseline and after 3 and 12 months after structured information and individually adapted exercise for patients with osteoarthritis in hip or knee.
The hypothesis of this study is that a supported self management of osteoarthritis program will increase the level of physical activity in patients with osteoarthritis in hip or knee. The second hypothesis is that patients with osteoarthritis in knee will increase their level of physical activity more than patients with osteoarthritis in hip.
Read the detailed description
Osteoarthritis (OA) is one of our most common chronic joint disorders. The World Health Organization (WHO) has estimated that every second woman and every fourth man over the age of 60 suffer some form of OA. OA is most common in hands, knee, hip and back. OA is a rheumatic disorder which affects the whole joint and may start as early as in the age of 30. The main symptoms are pain, stiffness and decreased quality of life.
The primary goals of OA management are to reduce the symptoms. Patient education and exercises are recommended as basic treatment according to national as well as international guidelines.
It is known that the level of physical activity decreases with age and that woman are less physical active than men. A study of healthy women older than 56 years showed that the level of activity decreased by 10 minutes per year, for every five year increase in age. OA is more common in women and is an irreversible disease, which means that the proportion of older women with osteoarthritis is large.
In addition OA is the most common cause of inactivity among the elderly and many fear that activity will further damage the joints. Inactivity is a large risk factor for poor physical and psychological health as well as premature death. Level of physical activity in people with OA has mainly been evaluated by self-assessment questionnaires. People with hip OA are more active than people with knee OA and the correlation between the degree of radiographic changes and physical activity is weak. Only 30% with early OA of the knee in the age group 35-65 years meet the recommendations for physical activity performed at least 30 minutes per day of moderate intensity, five days per week, measured by an accelerometer.
The primary aim of this study is to determine the effects of structured information and individually adapted exercises, delivered as a supported self-management osteoarthritis program, on overall levels of physical activity of moderate and vigorous intensity in patients with hip or knee OA. The secondary aim is to compare the level of physical activity in patients with hip and knee OA.
Supported self-management program for patients with osteoarthritis has been studied before and it's shown that it improves the quality of life, the physical function and decrease pain. No studies have investigated the effect of supported self-management on the level of physical activity.
This is an observational study with control group. Assessments are made at baseline and at 3 and 12 month after the supported self-management course.
The self-management program comprise three theoretical sessions, each of about 90 minutes, led by a physical therapist and held as group sessions with about 10 participants in each group. On the third session an osteoarthritis communicator participates. That is a person with osteoarthritis who communicate the lifestyle changes he/she have done to live a good life with OA. After the theoretical part the patients are offered an individually adapted exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist twice per week for 6 weeks. Patients are also encouraged to find one or two exercises to perform continuously as home exercises. During the program home exercise and other alternatives as changing activity, using walking sticks, pain management ect are introduced in order to maintain the level of physical activity over an extended period of time. The importance of being physically active for a long time is accentuated in all aspects of the patient education. The primary aim of the supported self-management program is to increase the level of physical activity and empower patients to manage their disease, avoid illness and live a good life despite osteoarthritis.
Physical activity is measured with an accelerometer at baseline, 3 month and 12 month. We will also study the correlation between objectivity measured physical activity with physical activity questionnaire (UCLA), quality of life (EQ-5D), pain (VAS 0-100) and comorbidity.
All subjects in our study are also registered in a Swedish national quality register called Better management of patients with osteoarthritis (BOA). Some of the data used in the present study are collected from the register.
- Conditions
- Osteoarthritis
- Being tested
- A supported self management of osteoarthritis program
- Keywords
- Osteoarthritis knee, Osteoarthritis hip, Physical activity, accelerometer
- Medical subject headings
- Osteoarthritis, Osteoarthritis, Knee, Osteoarthritis, Hip, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A supported self management of osteoarthritis programBehavioural
Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Supported self-management of osteoarthrits program | Experimental | Treatment with an supported self-management program for osteoarthritis. Receives: Behavioral: A supported self management of osteoarthritis program |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of Physical Activity/Sedentary Time
The level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.
Measured: Baseline, 3 months and 12 months
Level of Physical Activity/Low Activity
Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).
Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.
Measured: baseline, 3 months and12 months
Level of Physical Activity/Moderate-vigorous Activity
Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds).
Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.
Measured: baseline, 3 month and 12 month
Secondary outcomes (3)
Health Realted Quality of Life
To evaluate the health-related quality of life the EQ-5D-3L has been used. In this study, we have used the index of EQ-5D-3L with a British tariff. This scale is between (i.e., minimal value -0.594 (worst health), maximal value 1.00 (best health).
Measured: baseline, 3 months and 12 months
Visual Analog Scale for Pain
Visual Analog Scale for Pain has been used to evaluate pain. This is a scale from 0-100 mm there higher scores indicating higher intensity of pain. We have asked for the average pain the last month.
Measured: baseline, 3 months and 12 months
Arthritis Self-efficacy Scale/Pain (ASES)
The Arthritis Self-Efficacy Scale (ASES) is a widely used self-report measure of beliefs reflecting confidence in one's capacity to function despite pain and control pain or other symptoms of arthritis. ASES is scored on a 10-point Likert scale ranging from 10 (very uncertain=worst) to 100 (very certain=best).
Measured: baseline, 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startApr 2009
- Primary completionDec 2014
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- None (open label)
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region, The Swedish Rheumatism Ass
- Responsible party
- Sponsor
- Investigators
- Carina A Thorstensson, Ass prof, Principal investigator, Göteborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022566
- Sponsor's protocol ID
- 747-08
- Status last verified
- Dec 2021
- First submitted
- 18 Dec 2013
- Last updated
- 3 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Jonsson T, Ekvall Hansson E, Thorstensson CA, Eek F, Bergman P, Dahlberg LE. The effect of education and supervised exercise on physical activity, pain, quality of life and self-efficacy - an intervention study with a reference group. BMC Musculoskelet Disord. 2018 Jun 21;19(1):198. doi: 10.1186/s12891-018-2098-3.
PubMed 30037339
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Structured Information and Individually Adapted Exercise on Levels of Physical Activity Measured by Accelerometer in Patients With Knee or Hip Osteoarthritis - an Observational Study With Control Group.
- ClinicalTrials.gov ID
- NCT02022566
- Acronym / sponsor ID
- 747-08
- Conditions
- Osteoarthritis
- Keywords
- Osteoarthritis knee, Osteoarthritis hip, Physical activity, accelerometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region, The Swedish Rheumatism Ass
- Study start
- Apr 2009 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Posted 3 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Physical activity level is measured at baseline and after 3 and 12 months after structured information and individually adapted exercise for patients with osteoarthritis in hip or knee.
The hypothesis of this study is that a supported self management of osteoarthritis program will increase the level of physical activity in patients with osteoarthritis in hip or knee. The second hypothesis is that patients with osteoarthritis in knee will increase their level of physical activity more than patients with osteoarthritis in hip.
Detailed description
Osteoarthritis (OA) is one of our most common chronic joint disorders. The World Health Organization (WHO) has estimated that every second woman and every fourth man over the age of 60 suffer some form of OA. OA is most common in hands, knee, hip and back. OA is a rheumatic disorder which affects the whole joint and may start as early as in the age of 30. The main symptoms are pain, stiffness and decreased quality of life.
The primary goals of OA management are to reduce the symptoms. Patient education and exercises are recommended as basic treatment according to national as well as international guidelines.
It is known that the level of physical activity decreases with age and that woman are less physical active than men. A study of healthy women older than 56 years showed that the level of activity decreased by 10 minutes per year, for every five year increase in age. OA is more common in women and is an irreversible disease, which means that the proportion of older women with osteoarthritis is large.
In addition OA is the most common cause of inactivity among the elderly and many fear that activity will further damage the joints. Inactivity is a large risk factor for poor physical and psychological health as well as premature death. Level of physical activity in people with OA has mainly been evaluated by self-assessment questionnaires. People with hip OA are more active than people with knee OA and the correlation between the degree of radiographic changes and physical activity is weak. Only 30% with early OA of the knee in the age group 35-65 years meet the recommendations for physical activity performed at least 30 minutes per day of moderate intensity, five days per week, measured by an accelerometer.
The primary aim of this study is to determine the effects of structured information and individually adapted exercises, delivered as a supported self-management osteoarthritis program, on overall levels of physical activity of moderate and vigorous intensity in patients with hip or knee OA. The secondary aim is to compare the level of physical activity in patients with hip and knee OA.
Supported self-management program for patients with osteoarthritis has been studied before and it's shown that it improves the quality of life, the physical function and decrease pain. No studies have investigated the effect of supported self-management on the level of physical activity.
This is an observational study with control group. Assessments are made at baseline and at 3 and 12 month after the supported self-management course.
The self-management program comprise three theoretical sessions, each of about 90 minutes, led by a physical therapist and held as group sessions with about 10 participants in each group. On the third session an osteoarthritis communicator participates. That is a person with osteoarthritis who communicate the lifestyle changes he/she have done to live a good life with OA. After the theoretical part the patients are offered an individually adapted exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist twice per week for 6 weeks. Patients are also encouraged to find one or two exercises to perform continuously as home exercises. During the program home exercise and other alternatives as changing activity, using walking sticks, pain management ect are introduced in order to maintain the level of physical activity over an extended period of time. The importance of being physically active for a long time is accentuated in all aspects of the patient education. The primary aim of the supported self-management program is to increase the level of physical activity and empower patients to manage their disease, avoid illness and live a good life despite osteoarthritis.
Physical activity is measured with an accelerometer at baseline, 3 month and 12 month. We will also study the correlation between objectivity measured physical activity with physical activity questionnaire (UCLA), quality of life (EQ-5D), pain (VAS 0-100) and comorbidity.
All subjects in our study are also registered in a Swedish national quality register called Better management of patients with osteoarthritis (BOA). Some of the data used in the present study are collected from the register.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supported self-management of osteoarthrits program | Experimental | Behavioral: A supported self management of osteoarthritis programTreatment with an supported self-management program for osteoarthritis. |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age between 18 and 75 years old.
- Patients with clinically verified OA, coming to see a physical therapist for the Supported self-management of osteoarthritis program.
Key exclusion criteria (5 listed)
- Other serious disorders causing hip or knee pain (e.g. tumor, rheumatic arthritis, sequel hip fracture).
- Other symptoms more aggravating than the OA problem (e.g. chronic pain, fibromyalgia, cardio-respiratory dysfunction, spinal condition).
- Total joint replacement surgery within the past 12 months.
- Other surgery of knee or hip within the past 3 months.
- Unable to read and understand Swedish and follow verbal and visual instructions.
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 |
|---|---|---|
| A supported self management of osteoarthritis programThree theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks. | Behavioural | Supported self-management of osteoarthrits program |
Primary outcome
Level of Physical Activity/Sedentary Time
Time frame: Baseline, 3 months and 12 months
The level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.
Level of Physical Activity/Low Activity
Time frame: baseline, 3 months and12 months
Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.
Level of Physical Activity/Moderate-vigorous Activity
Time frame: baseline, 3 month and 12 month
Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.
3 secondary outcomes
Health Realted Quality of Life
Time frame: baseline, 3 months and 12 months
Visual Analog Scale for Pain
Time frame: baseline, 3 months and 12 months
Arthritis Self-efficacy Scale/Pain (ASES)
Time frame: baseline, 3 months and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30037339Jonsson T, Ekvall Hansson E, Thorstensson CA, Eek F, Bergman P, Dahlberg LE. The effect of education and supervised exercise on physical activity, pain, quality of life and self-efficacy - an intervention study with a reference group. BMC Musculoskelet Disord. 2018 Jun 21;19(1):198. doi: 10.1186/s12891-018-2098-3.
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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.
Carina A Thorstensson, Ass prof principal investigator
Göteborg 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 A supported self management of osteoarthritis program 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 Mar 2022. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Level of Physical Activity/Sedentary Time (time frame: Baseline, 3 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022566, which also lists 1 linked publication.
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 3 Mar 2022.