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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02387034
Date of registration: 06/03/2015
Prospective Registration: No
Primary sponsor: Uppsala University
Public title: Swedish PAP in Osteoarthritis - a RCT Study
Scientific title: The Effect on Swedish Physical Activity on Prescription (PAP) in Patients in Primary Care With Osteoarthritis in Knee or Hip - a RCT-study.
Date of first enrolment: June 2010
Target sample size: 140
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02387034
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Sweden
Contacts
Name:     Kjell Karlsson, head
Address: 
Telephone:
Email:
Affiliation:  Primary health care in Gävle
Name:     Margareta Emtner, PhD
Address: 
Telephone: +46907869887
Email: margareta.emtner@neuro.uu.se
Affiliation: 
Name:     Margareta Emtner, PhD
Address: 
Telephone: +46184714761
Email: margareta.emtner@neuro.uu.se
Affiliation: 
Key inclusion & exclusion criteria

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.



Age minimum: 40 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Sedentary
Osteoarthritis
Intervention(s)
Other: General advice
Behavioral: Physical activity on prescription
Primary Outcome(s)
Physical activity level [Time Frame: Change from baseline to 6, 12, 24 months]
Secondary Outcome(s)
Health related quality of Life, disease specific [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]
Body composition [Time Frame: Change from baseline to 6,12, 24 months]
Physical activity level [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]
Walking distance [Time Frame: Change from baseline to 6,12,24 months]
Secondary ID(s)
GAVLE-2014-FAR
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Region Gävleborg
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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