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Swedish PAP in Osteoarthritis - a RCT Study

Primary Purpose

Osteoarthritis, Sedentary

Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Physical activity on prescription
General advice
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Sedentary, Physical activity, Health related quality of life

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Uppsala UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Physical activity on prescription (PAP)

General advice

Arm Description

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 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.

Outcomes

Primary Outcome Measures

Physical activity level
Physical activity will be measured with an activity monitor (accelerometer).

Secondary Outcome Measures

Body composition
This will be measured with bio-impedance
Health related quality of Life , general
This will be measured with EQ-5D
Health related quality of Life, disease specific
HOOS, KOOS
Walking distance
This will be measured with six-minute walk test
Leg muscle strength and function
This will be measured with a standadised maximal step-up height test
Physical activity level
Physical activity will be assessed by a questionnaire.

Full Information

First Posted
March 6, 2015
Last Updated
June 16, 2017
Sponsor
Uppsala University
Collaborators
Region Gävleborg
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1. Study Identification

Unique Protocol Identification Number
NCT02387034
Brief Title
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

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Region Gävleborg

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Sedentary
Keywords
Osteoarthritis, Sedentary, Physical activity, Health related quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity on prescription (PAP)
Arm Type
Experimental
Arm Description
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.
Arm Title
General advice
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Physical activity on prescription
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
General advice
Intervention Description
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
Primary Outcome Measure Information:
Title
Physical activity level
Description
Physical activity will be measured with an activity monitor (accelerometer).
Time Frame
Change from baseline to 6, 12, 24 months
Secondary Outcome Measure Information:
Title
Body composition
Description
This will be measured with bio-impedance
Time Frame
Change from baseline to 6,12, 24 months
Title
Health related quality of Life , general
Description
This will be measured with EQ-5D
Time Frame
Change from baseline to 6,12,24 months
Title
Health related quality of Life, disease specific
Description
HOOS, KOOS
Time Frame
Change from baseline to 6,12,24 months
Title
Walking distance
Description
This will be measured with six-minute walk test
Time Frame
Change from baseline to 6,12,24 months
Title
Leg muscle strength and function
Description
This will be measured with a standadised maximal step-up height test
Time Frame
Change from baseline to 6,12,24 months
Title
Physical activity level
Description
Physical activity will be assessed by a questionnaire.
Time Frame
Change from baseline to 6,12,24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Margareta Emtner, PhD
Phone
+46907869887
Email
margareta.emtner@neuro.uu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Lena Kallings, Med Dr
Phone
+4682053824
Email
lena.kallings@gih.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell Karlsson, head
Organizational Affiliation
Primary health care in Gävle
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University
City
Uppsala
ZIP/Postal Code
75124
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margareta Emtner, PhD
Phone
+46184714761
Email
margareta.emtner@neuro.uu.se
First Name & Middle Initial & Last Name & Degree
Lena Kallings, PhD
Phone
+46812053824
Email
lena.kallings@gih.se
First Name & Middle Initial & Last Name & Degree
Regina Bendrik, PhD student

12. IPD Sharing Statement

Citations:
PubMed Identifier
33843297
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.
Results Reference
derived

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Swedish PAP in Osteoarthritis - a RCT Study

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