Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

Recruiting

• Conditions: Outcome Assessment (Health Care); Osteoarthritis, Knee; Rehabilitation; Recovery of Function; Treatment Outcome; Pain; Adults; Knee Brace; Patient Reported Outcome Measures
• Interventions: Other: Exercise therapy and education.

• Registration Number: NCT03949400
• Lead Sponsor: University College of Northern Denmark

Brief Summary

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).

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 Timeline

• Study Start: 2018-04-24
• Study First Submitted: 2018-10-02
• Status Verified: 2019-02
• Study First Submitted QC: 2019-05-10
• Last Update Submitted: 2019-05-10
• Study First Posted: 2019-05-14
• Last Update Posted: 2019-05-14
• Primary Completion: 2020-04-24
• Study Completion: 2029-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients diagnosed with knee OA	Exercise therapy and education.	Patients diagnosed with knee OA and assigned to undergo exercise therapy and education.

Primary Outcome Measures

Name	Time	Method
Pain - Numerical rating scale (NRS)	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.

Secondary Outcome Measures

Name	Time	Method
Y-balance test (YBT)	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.
Self-perceived knee stability question	6+12 weeks follow-up	Self-reported by the patients.
40-meter walk test	6+12 weeks follow-up	A test of walking speed over shirt distances and changing direction during walking

Trial Locations

Locations (1)

Aalborg Municipality, training unit west; 🇩🇰 Aalborg, Nothern, Denmark