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.
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 6, 2015
CompletedFirst Posted
Study publicly available on registry
March 12, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 20, 2017
June 1, 2017
7 years
March 6, 2015
June 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Physical activity level
Physical activity will be measured with an activity monitor (accelerometer).
Change from baseline to 6, 12, 24 months
Secondary Outcomes (6)
Body composition
Change from baseline to 6,12, 24 months
Health related quality of Life , general
Change from baseline to 6,12,24 months
Health related quality of Life, disease specific
Change from baseline to 6,12,24 months
Walking distance
Change from baseline to 6,12,24 months
Leg muscle strength and function
Change from baseline to 6,12,24 months
- +1 more secondary outcomes
Study Arms (2)
Physical activity on prescription (PAP)
EXPERIMENTALParticipants 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
OTHERParticipants 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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Uppsala Universitylead
- Region Gävleborgcollaborator
Study Sites (1)
Uppsala University
Uppsala, 75124, Sweden
Related Publications (1)
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.
PMID: 33843297DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kjell Karlsson, head
Primary health care in Gävle
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoiciate Professor
Study Record Dates
First Submitted
March 6, 2015
First Posted
March 12, 2015
Study Start
June 1, 2010
Primary Completion
June 1, 2017
Study Completion
December 1, 2020
Last Updated
June 20, 2017
Record last verified: 2017-06