Main
|
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: |
|
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
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|