The Effect of Structured Information and Individually Adapted Exercise on Levels of Physical Activity Measured by Accelerometer in Patients With Knee or Hip Osteoarthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Lund University
Sponsor:
Collaborators:
Vastra Gotaland Region
The Swedish Rheumatism Ass
Information provided by (Responsible Party):
Carina Thorstensson, Göteborg University
ClinicalTrials.gov Identifier:
NCT02022566
First received: December 18, 2013
Last updated: December 27, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Osteoarthritis
Behavioral: A supported self management of osteoarthritis program

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: The Effect of Structured Information and Individually Adapted Exercise on Levels of Physical Activity Measured by Accelerometer in Patients With Knee or Hip Osteoarthritis - an Observational Study With Control Group.

Resource links provided by NLM:


Further study details as provided by Lund University:

Primary Outcome Measures:
  • Level of physical activity [ Time Frame: 12 month ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    EQ-5D health questionnaire

  • Physical activity [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    UCLA physical activity questionnaire

  • Pain [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Visual Analog Scale for Pain 0-100

  • Charnley score [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    An index of comorbid conditions affecting walking abilities. (A=Unilateral hip or knee problems, B=bilateral hip or knee problems or C=Walking disabilities of other reasons)


Estimated Enrollment: 150
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Supported self-management of osteoarthrits program Behavioral: A supported self management of osteoarthritis program
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients are coming on referral to Supported self management of osteoartrithis program from doctors and physical therapists from primary care clinics and specialist clinics.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Other serious disorders causing hip or knee pain (e.g. tumor, rheumatic arthritis, sequel hip fracture).
  2. Other symptoms more aggravating than the OA problem (e.g. chronic pain, fibromyalgia, cardio-respiratory dysfunction, spinal condition).
  3. Total joint replacement surgery within the past 12 months.
  4. Other surgery of knee or hip within the past 3 months.
  5. Unable to read and understand Swedish and follow verbal and visual instructions.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02022566

Contacts
Contact: Therese S Jönsson, PhD student 004670336721 therese.jonsson@med.lu.se
Contact: Carina A Thorstensson, associate Professor 0046760 509 737 carina.thorstensson@registercentrum.se

Locations
Sweden
Skånes universitets sjukhus Recruiting
Lund, Sweden, 22241
Contact: Leif Dahlberg, Professor       leif.dahlberg@med.lu.se   
Principal Investigator: Therese S Jönsson, PhD student         
Sponsors and Collaborators
Lund University
Vastra Gotaland Region
The Swedish Rheumatism Ass
Investigators
Principal Investigator: Carina A Thorstensson, Ass prof Göteborg University
  More Information

No publications provided

Responsible Party: Carina Thorstensson, associate Professor, Göteborg University
ClinicalTrials.gov Identifier: NCT02022566     History of Changes
Other Study ID Numbers: 747-08
Study First Received: December 18, 2013
Last Updated: December 27, 2013
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Lund University:
Osteoarthritis knee
Osteoarthritis hip
Physical activity
accelerometer

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on August 28, 2014