The Effect of Medical Exercise Therapy on Pain, Function... | NCT02905747

Studies
The Effect of Medical Exercise Therapy on Pain, Function and Physical Activity in Patients With Knee Osteoarthritis

NCT02905747

Sponsor

Norwegian University of Science and Technology

Status

Completed

Last Update Posted

Mar 11, 2019Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Osteoarthritis, Knee

Interventions

Medical Exercise Therapy

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Dec 1, 2018Actual

Completion Date

Dec 1, 2018Actual

First Submitted Date

Sep 14, 2016

First Submission Date that Met QC Criteria

Sep 16, 2016

First Posted Date

Sep 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2019

Last Update Posted Date

Mar 11, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical Exercise Therapy	Experimental	Medical Exercise Therapy (MET) developed by Oddvar Holten	Behavioral: Medical Exercise Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Exercise Therapy	Behavioral	physiotherapy intervention with Medical exercise therapy (MET) during 3 months	Medical Exercise Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	visual analog scale	6 months
Activity level	Accelerometer	6 months
Function	30 second chair stand test	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Håvard Østerås, phd	Norwegian University of Science and Technology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NTNU		Trondheim			Norway

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30929225	Derived	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.

ID	Term
D020370	Osteoarthritis, Knee
D059352	Musculoskeletal Pain

ID	Term
D010003	Osteoarthritis
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases