OsteoarthritisNCT02387034
Swedish PAP in Osteoarthritis - a RCT Study
A study testing Physical activity on prescription and General advice in people with Osteoarthritis and Sedentary, run by Uppsala University at 1 site in Sweden.
Trial summary
The purpose of this study is to determine whether an intervention with Physical activity on prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would result in effects on physical activity level, physical capacity and quality on life. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Sedentary
- What is being tested?
- Physical activity on prescription and General advice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2010to Dec 2020
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with clinically verified osteoarthritis in knee or hip
- Sedentary (physical activity level, less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity a week) includes
Who cannot join
- Severe pain in hip or knee when walking
- Other serious disorders causing problems when walking
- Back injury causing pain in the leg
- Cruciate ligament injury in the knee which causes severe dysfunction
- Severe menisci injury
- Total joint replacement in hip or knee
- Unable to understand Swedish and follow verbal visual instructions
- Study population: Patients who contact primary care center because of their hip or knee osteoarthritis and which is referred to the physical therapist. Seven health centers in Gävle include patients.
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University
Uppsala, 75124
Margareta Emtner, PhD, +46184714761, margareta.emtner@neuro.uu.se
Lena Kallings, PhD, +46812053824, lena.kallings@gih.se
About this study
Official title: The Effect on Swedish Physical Activity on Prescription (PAP) in Patients in Primary Care With Osteoarthritis in Knee or Hip - a RCT-study.
The purpose of this study is to determine whether an intervention with Physical activity on prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would result in effects on physical activity level, physical capacity and quality on life.
The hypothesis is that patients with osteoarthritis in hip or knee will increase their level of physical activity significantly more with a PAP intervention compared to patients who only get general advice about physical activity.
Read the detailed description
According to guidelines the recommended first-line management for people with osteoarthritis consist of exercise, information about osteoarthritis and if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in these patients. Therefore, it is important to have methods to increase physical activity levels in these patients. It is not explored whether an intervention with PAP may lead to increased physical activity in patients with knee or hip osteoarthritis. The study will be a prospective, randomized, single-blind intervention study including 140 patients (70 patients/group). Patients will in a parallel design be randomized to intervention or control group. Both groups receive oral and written information about osteoarthritis and if necessary, advice on weight loss. The intervention group receives Swedish Physical activity on prescription. It is a patient-centered counselling about physical activity related to the disease. The counselling results in an individualized written prescription on physical activity including specific modes on physical activity. After three weeks, three months and six months they are offered a follow up which could be by telephone or personal meeting. During the follow up they discuss who the physical activity works out and plan new goals. The control group will receive an intervention with general advice about being active three times a week and do strength training functional during the day. Patients in the control group see the physiotherapist once.
- Conditions
- Osteoarthritis, Sedentary
- Being tested
- Physical activity on prescription, General advice
- Keywords
- Osteoarthritis, Sedentary, Physical activity, Health related quality of life
- Medical subject headings
- Osteoarthritis, Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity on prescriptionBehavioural
Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and a patient-centered counselling about physical activity related to the disease. It leads to a Swedish Physical activity on prescription (PAP). It is an individualized written prescription on physical activity and includes specific mode of physical activity. The patient is contacted by telephone or visit the physiotherapist after three weeks, three months and six months.
General adviceOther
Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and receive an intervention with general advice about physical activity
| Study group | Role | What they receive |
|---|---|---|
| Physical activity on prescription (PAP) | Experimental | Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and a patient-centered counselling about physical activity related to the disease. It leads to a Swedish Physical activity on prescription (PAP). It is an individualized written prescription on physical activity and includes specific mode of physical activity. The patient is contacted by telephone or visit the physiotherapist after three weeks, three months and six months. Receives: Behavioral: Physical activity on prescription |
| General advice | Other | Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and receive an intervention with general advice about being active with cardiovascular exercise such as walking, cycling or otherwise in 30 minutes three times a week and do strength training functional during the day such as walk in stairs and getting up from a chair without hand support. Receives: Other: General advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity level
Physical activity will be measured with an activity monitor (accelerometer).
Measured: Change from baseline to 6, 12, 24 months
Secondary outcomes (6)
Body composition
This will be measured with bio-impedance
Measured: Change from baseline to 6,12, 24 months
Health related quality of Life , general
This will be measured with EQ-5D
Measured: Change from baseline to 6,12,24 months
Health related quality of Life, disease specific
HOOS, KOOS
Measured: Change from baseline to 6,12,24 months
Walking distance
This will be measured with six-minute walk test
Measured: Change from baseline to 6,12,24 months
Leg muscle strength and function
This will be measured with a standadised maximal step-up height test
Measured: Change from baseline to 6,12,24 months
Physical activity level
Physical activity will be assessed by a questionnaire.
Measured: Change from baseline to 6,12,24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2015 (estimated)
- Study startJun 2010
- Primary completionJun 2017 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Gävleborg
- Responsible party
- Principal investigator, Margareta Emtner, Uppsala University
- Investigators
- Kjell Karlsson, head, Principal investigator, Primary health care in Gävle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387034
- Sponsor's protocol ID
- GAVLE-2014-FAR
- Status last verified
- Jun 2017
- First submitted
- 6 Mar 2015
- Last updated
- 20 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Bendrik R, Kallings LV, Broms K, Kunanusornchai W, Emtner M. Physical activity on prescription in patients with hip or knee osteoarthritis: A randomized controlled trial. Clin Rehabil. 2021 Oct;35(10):1465-1477. doi: 10.1177/02692155211008807. Epub 2021 Apr 11.
PubMed 33843297
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect on Swedish Physical Activity on Prescription (PAP) in Patients in Primary Care With Osteoarthritis in Knee or Hip - a RCT-study.
- ClinicalTrials.gov ID
- NCT02387034
- Acronym / sponsor ID
- GAVLE-2014-FAR
- Conditions
- Osteoarthritis, Sedentary
- Keywords
- Osteoarthritis, Sedentary, Physical activity, Health related quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Region Gävleborg
- Study start
- Jun 2010
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 12 Mar 2015 (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 determine whether an intervention with Physical activity on prescription (PAP) to individuals in primary care with knee or hip osteoarthritis would result in effects on physical activity level, physical capacity and quality on life.
The hypothesis is that patients with osteoarthritis in hip or knee will increase their level of physical activity significantly more with a PAP intervention compared to patients who only get general advice about physical activity.
Detailed description
According to guidelines the recommended first-line management for people with osteoarthritis consist of exercise, information about osteoarthritis and if necessary, weight reduction. It is well documented that exercise has a positive effect on pain and physical function in these patients. Therefore, it is important to have methods to increase physical activity levels in these patients. It is not explored whether an intervention with PAP may lead to increased physical activity in patients with knee or hip osteoarthritis. The study will be a prospective, randomized, single-blind intervention study including 140 patients (70 patients/group). Patients will in a parallel design be randomized to intervention or control group. Both groups receive oral and written information about osteoarthritis and if necessary, advice on weight loss. The intervention group receives Swedish Physical activity on prescription. It is a patient-centered counselling about physical activity related to the disease. The counselling results in an individualized written prescription on physical activity including specific modes on physical activity. After three weeks, three months and six months they are offered a follow up which could be by telephone or personal meeting. During the follow up they discuss who the physical activity works out and plan new goals. The control group will receive an intervention with general advice about being active three times a week and do strength training functional during the day. Patients in the control group see the physiotherapist once.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity on prescription (PAP) | Experimental | Behavioral: Physical activity on prescriptionParticipants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and a patient-centered counselling about physical activity related to the disease. It leads to a Swedish Physical activity on prescription (PAP). It is an individualized written prescription on physical activity and includes specific mode of physical activity. The patient is contacted by telephone or visit the physiotherapist after three weeks, three months and six months. |
| General advice | Other | Other: General adviceParticipants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and receive an intervention with general advice about being active with cardiovascular exercise such as walking, cycling or otherwise in 30 minutes three times a week and do strength training functional during the day such as walk in stairs and getting up from a chair without hand support. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with clinically verified osteoarthritis in knee or hip
- Sedentary (physical activity level, less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity a week) includes
Key exclusion criteria (8 listed)
- Severe pain in hip or knee when walking
- Other serious disorders causing problems when walking
- Back injury causing pain in the leg
- Cruciate ligament injury in the knee which causes severe dysfunction
- Severe menisci injury
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 |
|---|---|---|
| Physical activity on prescriptionParticipants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and a patient-centered counselling about physical activity related to the disease. It leads to a Swedish Physical activity on prescription (PAP). It is an individualized written prescription on physical activity and includes specific mode of physical activity. The patient is contacted by telephone or visit the physiotherapist after three weeks, three months and six months. | Behavioural | Physical activity on prescription (PAP) |
| General adviceParticipants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and receive an intervention with general advice about physical activity | Other | General advice |
Primary outcome
Physical activity level
Time frame: Change from baseline to 6, 12, 24 months
Physical activity will be measured with an activity monitor (accelerometer).
6 secondary outcomes
Body composition
Time frame: Change from baseline to 6,12, 24 months
Health related quality of Life , general
Time frame: Change from baseline to 6,12,24 months
Health related quality of Life, disease specific
Time frame: Change from baseline to 6,12,24 months
Walking distance
Time frame: Change from baseline to 6,12,24 months
Leg muscle strength and function
Time frame: Change from baseline to 6,12,24 months
Physical activity level
Time frame: Change from baseline to 6,12,24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2017.
- Derived from this study: PubMed 33843297Bendrik R, Kallings LV, Broms K, Kunanusornchai W, Emtner M. Physical activity on prescription in patients with hip or knee osteoarthritis: A randomized controlled trial. Clin Rehabil. 2021 Oct;35(10):1465-1477. doi: 10.1177/02692155211008807. Epub 2021 Apr 11.
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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.
Kjell Karlsson, head principal investigator
Primary health care in Gävle
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity on prescription and General advice in people with Osteoarthritis and Sedentary, run by Uppsala 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 8 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: status not confirmed, as of the sponsor's last update on 20 Jun 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Margareta Emtner, PhD (+46907869887, margareta.emtner@neuro.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity level (time frame: Change from baseline to 6, 12, 24 months). 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 NCT02387034, 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 20 Jun 2017.