The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
Primary Purpose
Osteoarthritis, Knee
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Medical Exercise Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Exercise Therapy, Musculoskeletal Pain, Knee osteoarthritis, Physical Therapy Modalities
Eligibility Criteria
Inclusion Criteria:
- x-ray verified knee osteoarthritis (Kellegren & Lawrence grade I-III)
- Loss of function and withstanding pain >3 months
Exclusion Criteria:
- 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
Sites / Locations
- NTNU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Medical Exercise Therapy
Arm Description
Medical Exercise Therapy (MET) developed by Oddvar Holten
Outcomes
Primary Outcome Measures
pain
visual analog scale
Activity level
Accelerometer
Function
30 second chair stand test
Secondary Outcome Measures
Full Information
NCT ID
NCT02905747
First Posted
September 14, 2016
Last Updated
March 7, 2019
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT02905747
Brief Title
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
Official Title
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (Actual)
Primary Completion Date
December 1, 2018 (Actual)
Study Completion Date
December 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Exercise Therapy, Musculoskeletal Pain, Knee osteoarthritis, Physical Therapy Modalities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Medical Exercise Therapy
Arm Type
Experimental
Arm Description
Medical Exercise Therapy (MET) developed by Oddvar Holten
Intervention Type
Behavioral
Intervention Name(s)
Medical Exercise Therapy
Intervention Description
physiotherapy intervention with Medical exercise therapy (MET) during 3 months
Primary Outcome Measure Information:
Title
pain
Description
visual analog scale
Time Frame
6 months
Title
Activity level
Description
Accelerometer
Time Frame
6 months
Title
Function
Description
30 second chair stand test
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
x-ray verified knee osteoarthritis (Kellegren & Lawrence grade I-III)
Loss of function and withstanding pain >3 months
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Håvard Østerås, phd
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
NTNU
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30929225
Citation
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.
Results Reference
derived
Learn more about this trial
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis
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