Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

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

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

• 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

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

How is the study designed?

Number of groups / cohorts

1

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)	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)	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	Self-reported by the patients.	6+12 weeks follow-up
40-meter walk test	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)	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	Self-reported pain assessment by the patients.	6+12 weeks follow up
Likert scale	Self-reported by the patients	6+12 weeks follow-up
Analgetic pain medication intake	Self-reported by the patients.	6+12 weeks follow-up

Collaborators and Investigators

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

Study record dates

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: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• 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