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Swedish PAP in Osteoarthritis - a RCT Study

The Effect on Swedish Physical Activity on Prescription (PAP) in Patients in Primary Care With Osteoarthritis in Knee or Hip - a RCT-study.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02387034
Enrollment
140
Registered
2015-03-12
Start date
2010-06-30
Completion date
2020-12-31
Last updated
2017-06-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Sedentary

Keywords

Osteoarthritis, Sedentary, Physical activity, Health related quality of life

Brief 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. 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.

Interventions

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.

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

Sponsors

Region Gävleborg
CollaboratorOTHER
Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients with clinically verified osteoarthritis in knee or hip 2. Sedentary (physical activity level, less than 150 minutes of moderate-intensity or less than 75 minutes of vigorous-intensity a week) includes

Exclusion criteria

1. Severe pain in hip or knee when walking 2. Other serious disorders causing problems when walking 3. Back injury causing pain in the leg 4. Cruciate ligament injury in the knee which causes severe dysfunction 5. Severe menisci injury 6. Total joint replacement in hip or knee 7. 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.

Design outcomes

Primary

MeasureTime frameDescription
Physical activity levelChange from baseline to 6, 12, 24 monthsPhysical activity will be measured with an activity monitor (accelerometer).

Secondary

MeasureTime frameDescription
Health related quality of Life , generalChange from baseline to 6,12,24 monthsThis will be measured with EQ-5D
Health related quality of Life, disease specificChange from baseline to 6,12,24 monthsHOOS, KOOS
Body compositionChange from baseline to 6,12, 24 monthsThis will be measured with bio-impedance
Leg muscle strength and functionChange from baseline to 6,12,24 monthsThis will be measured with a standadised maximal step-up height test
Physical activity levelChange from baseline to 6,12,24 monthsPhysical activity will be assessed by a questionnaire.
Walking distanceChange from baseline to 6,12,24 monthsThis will be measured with six-minute walk test

Countries

Sweden

Contacts

Primary ContactMargareta Emtner, PhD
margareta.emtner@neuro.uu.se+46907869887
Backup ContactLena Kallings, Med Dr
lena.kallings@gih.se+4682053824

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026