NCT02022566

Brief Summary

Physical activity level is measured at baseline and after 3 and 12 months after structured information and individually adapted exercise for patients with osteoarthritis in hip or knee. The hypothesis of this study is that a supported self management of osteoarthritis program will increase the level of physical activity in patients with osteoarthritis in hip or knee. The second hypothesis is that patients with osteoarthritis in knee will increase their level of physical activity more than patients with osteoarthritis in hip.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
317

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

December 18, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 30, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

March 3, 2022

Completed
Last Updated

March 3, 2022

Status Verified

December 1, 2021

Enrollment Period

5.7 years

First QC Date

December 18, 2013

Results QC Date

March 25, 2019

Last Update Submit

December 13, 2021

Conditions

Osteoarthritis

Keywords

Osteoarthritis kneeOsteoarthritis hipPhysical activityaccelerometer

Outcome Measures

Primary Outcomes (3)

  • Level of Physical Activity/Sedentary Time

    The level of physical activity will be monitored by a GT1M Actigraph which is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from the morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip. The account of minutes in sedentary time will be calculated and the average of minutes in one week will be used.

    Baseline, 3 months and 12 months

  • Level of Physical Activity/Low Activity

    Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.

    baseline, 3 months and12 months

  • Level of Physical Activity/Moderate-vigorous Activity

    Level of physical activity will be monitored by an accelerometer at baseline and at 3 and 12 months after the supported self-management of osteoarthritis program using an accelerometer. The GT1M Actigraph is a small uniaxial accelerometer that measures vertical acceleration and deceleration. Accelerometer output is an activity "count" which is the weighted sum of the number of accelerations measured over a period (e.g. in this case 10 seconds). Participants will be instructed to wear the accelerometer from morning, and continuously (except for water activities) until going to bed at night, for seven consecutive days. The accelerometer will be attached to a belt to wear around the waist with accelerometer placement on the right hip.

    baseline, 3 month and 12 month

Secondary Outcomes (3)

  • Health Realted Quality of Life

    baseline, 3 months and 12 months

  • Visual Analog Scale for Pain

    baseline, 3 months and 12 months

  • Arthritis Self-efficacy Scale/Pain (ASES)

    baseline, 3 months and 12 months

Study Arms (2)

Supported self-management of osteoarthrits program

EXPERIMENTAL

Treatment with an supported self-management program for osteoarthritis.

Behavioral: A supported self management of osteoarthritis program

Control group

NO INTERVENTION

No intervention

Interventions

A supported self management of osteoarthritis programBEHAVIORAL

Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.

Supported self-management of osteoarthrits program

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 75 years old.
  • Patients with clinically verified OA, coming to see a physical therapist for the Supported self-management of osteoarthritis program.

You may not qualify if:

  • Other serious disorders causing hip or knee pain (e.g. tumor, rheumatic arthritis, sequel hip fracture).
  • Other symptoms more aggravating than the OA problem (e.g. chronic pain, fibromyalgia, cardio-respiratory dysfunction, spinal condition).
  • Total joint replacement surgery within the past 12 months.
  • Other surgery of knee or hip within the past 3 months.
  • Unable to read and understand Swedish and follow verbal and visual instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skånes universitets sjukhus

Lund, 22241, Sweden

Location

Related Publications (1)

  • Jonsson T, Ekvall Hansson E, Thorstensson CA, Eek F, Bergman P, Dahlberg LE. The effect of education and supervised exercise on physical activity, pain, quality of life and self-efficacy - an intervention study with a reference group. BMC Musculoskelet Disord. 2018 Jun 21;19(1):198. doi: 10.1186/s12891-018-2098-3.

    PMID: 30037339DERIVED

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, KneeOsteoarthritis, HipMotor Activity

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesBehavior

Results Point of Contact

Title
Physical therapist Therese Jönsson
Organization
Lunds university
therese.jonsson@med.lu.se
0046703360721

Study Officials

  • Carina A Thorstensson, Ass prof

    Göteborg University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2013

First Posted

December 30, 2013

Study Start

April 1, 2009

Primary Completion

December 1, 2014

Study Completion

June 1, 2018

Last Updated

March 3, 2022

Results First Posted

March 3, 2022

Record last verified: 2021-12

Locations

SE(1)