Clinical trial NCT02387034: Swedish PAP in Osteoarthritis - a RCT 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Sedentary
Keywords: Osteoarthritis
Sedentary
Physical activity
Health related quality of life
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Region Gävleborg
First posted: 2015-03-12
Enrollment: 140
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Physical activity level
timeFrame: Change from baseline to 6, 12, 24 months
Secondary outcomes:
measure: Body composition
timeFrame: Change from baseline to 6,12, 24 months
measure: Health related quality of Life , general
timeFrame: Change from baseline to 6,12,24 months
measure: Health related quality of Life, disease specific
timeFrame: Change from baseline to 6,12,24 months
measure: Walking distance
timeFrame: Change from baseline to 6,12,24 months
measure: Leg muscle strength and function
timeFrame: Change from baseline to 6,12,24 months
measure: Physical activity level
timeFrame: Change from baseline to 6,12,24 months
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Primary health care in Gävle
name: Kjell Karlsson, head
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.