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RecruitingNCT03949400Updated May 14, 2019

Effects of Exercise Therapy and Soft Brace on Knee Osteoarthritis

An observational study in Rehabilitation, Treatment Outcome and Pain, sponsored by University College of Northern Denmark. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-14.

Sponsored by University College of Northern Denmark · Observational

From the registry’s dates

  • Primary completion was expected by Apr 2020, 6 years 5 months ago, but the record still lists the study as recruiting.
  • Started Apr 2018; still recruiting 8 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
40
Ages
18 Years and older
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Rehabilitation
  • Treatment Outcome
  • Pain
  • Knee Brace
  • Outcome Assessment (Health Care)
  • Recovery of Function
  • Patient Reported Outcome Measures
  • Adults
  • Osteoarthritis, Knee
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's planned enrollment of 40 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

University College of Northern Denmark is the lead sponsor of 19 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

Not mentally able to reply to the questionnaire

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients diagnosed with knee OA

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

    Other: Exercise therapy and education.

Interventions

  • OtherExercise therapy and education.

    Exercise therapy and education, physiotherapy rehab at Aalborg Municipality

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 6+12 weeks follow-up

Secondary outcomes

  1. 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.

    Time frame: 6+12 weeks follow-up

  2. Self-perceived knee stability question

    Self-reported by the patients.

    Time frame: 6+12 weeks follow-up

  3. 40-meter walk test

    A test of walking speed over shirt distances and changing direction during walking

    Time frame: 6+12 weeks follow-up

Other outcomes

  1. 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.

    Time frame: 6+12 weeks follow-up

  2. Pain manikin

    Self-reported pain assessment by the patients.

    Time frame: 6+12 weeks follow up

  3. Likert scale

    Self-reported by the patients

    Time frame: 6+12 weeks follow-up

  4. Analgetic pain medication intake

    Self-reported by the patients.

    Time frame: 6+12 weeks follow-up

07

Study locations

1 of 1 sites recruiting
  • Aalborg Municipality, training unit west
    Aalborg, Nothern 9000, Denmark
    • Ina Lesager · Contact · +4531990452
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03949400
Lead sponsor
University College of Northern Denmark
Responsible party
Sponsor
First posted
May 14, 2019
Start date
Apr 24, 2018
Primary completion
Apr 24, 2020 (estimated)
Completion
May 20, 2029 (estimated)
Last update
May 14, 2019

Study contacts

Palle S Jensen, Adjunct
Contact
plj@ucn.dk
+4581719719
Steffan W Christensen, PhD
Contact
sec@ucn.dk
+4572691009
Dorte Drachmann
study director · Department of Physiotherapy, University College of Northern Denmark

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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