Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

May 10, 2019 updated by: University College of Northern Denmark
The primary aim of the study is to investigate the effects of supervised exercise therapy and education on the immediate response to using a soft knee brace in patients with knee osteoarthritis (OA).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study type: observational Estimated enrollment: 40 participants Observational model: cohort Time perspective: prospective

Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire

Patients are tested with and without the brace before starting the exercise therapy and education program and re-tested with and without the brace after completing the treatment program (6 weeks) and again at 12 weeks.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Palle S Jensen, Adjunct
  • Phone Number: +4581719719
  • Email: plj@ucn.dk

Study Contact Backup

  • Name: Steffan W Christensen, PhD
  • Phone Number: +4572691009
  • Email: sec@ucn.dk

Study Locations

  • Denmark
    • Nothern
      • Aalborg, Nothern, Denmark, 9000
        • Recruiting
        • Aalborg Municipality, training unit west
        • Contact:
          • Ina Lesager
          • Phone Number: +4531990452

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with knee OA and assigned to undergo exercise therapy and education

Description

Inclusion Criteria:

Assigned for exercise and education due to knee osteoarthrosis Age 18 years or older at the time of recruitment Able to read and understand Danish

Exclusion Criteria:

Not mentally able to reply to the questionnaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients diagnosed with knee OA
Patients diagnosed with knee OA and assigned to undergo exercise therapy and education.
Other: Exercise therapy and education.
Exercise therapy and education, physiotherapy rehab at Aalborg Municipality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain - Numerical rating scale (NRS)
Time Frame: 6+12 weeks follow-up
NRS is the most common pain scale for quantification pain. The respondent selects a whole number on a scale from 0-10, that best reflects the intensity of his/her pain. 0 being no pain, 10 being the worst pain imaginable.
6+12 weeks follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Y-balance test (YBT)
Time Frame: 6+12 weeks follow-up
The YBT test is a test commonly used in clinical practice to investigate functional balance. The YBT is based on the Star Excursion Balance Test and it has been thoroughly researched. Measured with and without the soft knee brace at baseline, after the treatment program and at 12weeks.
6+12 weeks follow-up
Self-perceived knee stability question
Time Frame: 6+12 weeks follow-up
Self-reported by the patients.
6+12 weeks follow-up
40-meter walk test
Time Frame: 6+12 weeks follow-up
A test of walking speed over shirt distances and changing direction during walking
6+12 weeks follow-up

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knee injury and Osteoarthritis Outcome Score (KOOS) (continous)
Time Frame: 6+12 weeks follow-up
An instrument to assess the patient's opinion about their knee and associated problems. KOOS has been evaluated and compared to other instruments in several studies. Measured at baseline, after the treatment program and at 12weeks.
6+12 weeks follow-up
Pain manikin
Time Frame: 6+12 weeks follow up
Self-reported pain assessment by the patients.
6+12 weeks follow up
Likert scale
Time Frame: 6+12 weeks follow-up
Self-reported by the patients
6+12 weeks follow-up
Analgetic pain medication intake
Time Frame: 6+12 weeks follow-up
Self-reported by the patients.
6+12 weeks follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College of Northern Denmark

Investigators

  • Study Director: Dorte Drachmann, Department of Physiotherapy, University College of Northern Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2018

Primary Completion (Anticipated)

April 24, 2020

Study Completion (Anticipated)

May 20, 2029

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

May 10, 2019

First Posted (Actual)

May 14, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2019

Last Update Submitted That Met QC Criteria

May 10, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOU-UU-2018-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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