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.

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis; Sedentary
• Intervention / Treatment: Behavioral: Physical activity on prescription; Other: General advice

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, 75124
    • Recruiting
    • Uppsala University
    • Contact: Margareta Emtner, PhD; Phone Number: +46184714761; Email: margareta.emtner@neuro.uu.se
    • Contact: Lena Kallings, PhD; Phone Number: +46812053824; Email: lena.kallings@gih.se
    • Principal Investigator: Regina Bendrik, PhD student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity on prescription (PAP); 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.	Behavioral: Physical activity on prescription; 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.
Other: General advice; Participants 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.	Other: General advice; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical activity level	Physical activity will be measured with an activity monitor (accelerometer).	Change from baseline to 6, 12, 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	This will be measured with bio-impedance	Change from baseline to 6,12, 24 months
Health related quality of Life , general	This will be measured with EQ-5D	Change from baseline to 6,12,24 months
Health related quality of Life, disease specific	HOOS, KOOS	Change from baseline to 6,12,24 months
Walking distance	This will be measured with six-minute walk test	Change from baseline to 6,12,24 months
Leg muscle strength and function	This will be measured with a standadised maximal step-up height test	Change from baseline to 6,12,24 months
Physical activity level	Physical activity will be assessed by a questionnaire.	Change from baseline to 6,12,24 months

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Region Gävleborg
• Investigators: Principal Investigator: Kjell Karlsson, head, Primary health care in Gävle

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): June 1, 2017
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: March 6, 2015
• First Submitted That Met QC Criteria: March 11, 2015
• First Posted (Estimate): March 12, 2015

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 16, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Osteoarthritis; Physical activity; Sedentary; Health related quality of life
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: GAVLE-2014-FAR