NCT02905747

Brief Summary

The aim of the project is to investigate effects of medical exercise therapy (MET) on patients with knee osteoarthritis. MET is a common physical therapy intervention, and the project aim to strengthen the evidence of this intervention. An experimental cohort design is chosen, and 20 participants will be followed for 6 months. Assessments will be clinical tests, questionnaires and accelerometer measurements before, during, and after a 3 month period of exercise (3 days per week) with a physical therapist. The project will answer if a 3 month physical therapy intervention using MET causes changes in pain level, function and activity level for patients with knee osteoarthritis. In addition, it will investigate whether a single global endurance workout for 30 minutes will have an effect on pain level for these patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

March 11, 2019

Status Verified

March 1, 2019

Enrollment Period

2.2 years

First QC Date

September 14, 2016

Last Update Submit

March 7, 2019

Conditions

Keywords

Exercise TherapyMusculoskeletal PainKnee osteoarthritisPhysical Therapy Modalities

Outcome Measures

Primary Outcomes (3)

  • pain

    visual analog scale

    6 months

  • Activity level

    Accelerometer

    6 months

  • Function

    30 second chair stand test

    6 months

Study Arms (1)

Medical Exercise Therapy

EXPERIMENTAL

Medical Exercise Therapy (MET) developed by Oddvar Holten

Behavioral: Medical Exercise Therapy

Interventions

physiotherapy intervention with Medical exercise therapy (MET) during 3 months

Medical Exercise Therapy

Eligibility Criteria

Age45 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • x-ray verified knee osteoarthritis (Kellegren \& Lawrence grade I-III)
  • Loss of function and withstanding pain \>3 months

You may not qualify if:

  • physical therapy treatment during the last 3 months
  • knee injury
  • inflammatory arthritis
  • symptoms from the hip joints greater than the knee pain
  • planned knee surgery the next 6 months
  • heart and lung disorders or other health issues affecting the ability to complete the intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTNU

Trondheim, Norway

Location

Related Publications (1)

  • Osteras H, Paulsberg F. The Effect of Medical Exercise Therapy on Pressure Sensitivity in Patients with Knee Osteoarthritis: A Cohort Pilot Study. Pain Ther. 2019 Jun;8(1):79-87. doi: 10.1007/s40122-019-0121-5. Epub 2019 Mar 30.

MeSH Terms

Conditions

Osteoarthritis, KneeMusculoskeletal Pain

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMuscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Håvard Østerås, phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

March 11, 2019

Record last verified: 2019-03

Locations