NCT02387034

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 12, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

7 years

First QC Date

March 6, 2015

Last Update Submit

June 16, 2017

Conditions

Keywords

OsteoarthritisSedentaryPhysical activityHealth related quality of life

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)

EXPERIMENTAL

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

General advice

OTHER

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

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.

Physical activity on prescription (PAP)

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

General advice

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Uppsala University

Uppsala, 75124, Sweden

RECRUITING

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.

MeSH Terms

Conditions

OsteoarthritisSedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Study Officials

  • Kjell Karlsson, head

    Primary health care in Gävle

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margareta Emtner, PhD

CONTACT

Lena Kallings, Med Dr

CONTACT

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

Locations