Changes in Physical Inactivity in Patients with Knee Oste... | NCT03125954

Studies
Changes in Physical Inactivity in Patients with Knee Osteoarthritis

NCT03125954

Sponsor

Frederiksberg University Hospital

Status

Completed

Last Update Posted

Feb 27, 2025Actual

Enrollment

38Actual

Phase

Not provided

Conditions

Knee Osteoarthritis

Interventions

standardized exercise treatment for knee OA in Denmark (GLAiD)

Countries

Denmark

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

Dec 2018

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

May 8, 2017Actual

Primary Completion Date

Jul 29, 2018Actual

Completion Date

Jul 29, 2018Actual

First Submitted Date

Mar 21, 2017

First Submission Date that Met QC Criteria

Apr 19, 2017

First Posted Date

Apr 24, 2017Actual

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

Feb 25, 2025

Last Update Posted Date

Feb 27, 2025Actual

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an objective cohort study using objective recording of physical activity (accelerometry) during and after the GLAiD intervention to investigate if a sedentary behavior change by participating in an 6-week physiotherapy-led exercise and education program (GLAiD) occurs. The GLAiD intervention is an education and exercise based intervention aiming at decreasing pain and improving function in patients with knee osteoarthritis.

The primary outcome is change in objective recorded physical activity between baseline and follow-up.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
standardized exercise treatment for knee OA in Denmark (GLAiD)	Other	objective measurement of physical activity before, during af after the GLAiD intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Objectively measured physical activity	accelerometer recorded physical activity	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Knee Injury and Osteoarthritis Outcome Score(KOOS)	KOOS questionnaire	baseline (day 1) and follow-up (after 6 weeks)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

≥40 years
Diagnosed with knee OA
Willing and able to complete study visits and procedures
Owner of a smartphone or tablet
Eligible for participation in the GLAID treatment
Speaks, reads and writes Danish language

Exclusion Criteria:

Any condition, which in the opinion of the Investigator, would put the subject at increased safety risk by participation, or otherwise make the subject unsuitable for this study.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with knee osteoarthritis refered to the GLAiD program

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Parker Institute		Copenhagen			Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33197825	Derived	Bartholdy C, Skou ST, Bliddal H, Henriksen M. Changes in physical inactivity during supervised educational and exercise therapy in patients with knee osteoarthritis: A prospective cohort study. Knee. 2020 Dec;27(6):1848-1856. doi: 10.1016/j.knee.2020.09.007. Epub 2020 Nov 13.

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