NCT03125954

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

May 8, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2018

Completed
Last Updated

February 27, 2025

Status Verified

December 1, 2018

Enrollment Period

1.2 years

First QC Date

March 21, 2017

Last Update Submit

February 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Objectively measured physical activity

    accelerometer recorded physical activity

    6 weeks

Secondary Outcomes (1)

  • Knee Injury and Osteoarthritis Outcome Score(KOOS)

    baseline (day 1) and follow-up (after 6 weeks)

Interventions

objective measurement of physical activity before, during af after the GLAiD intervention

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient with knee osteoarthritis refered to the GLAiD program

You may qualify if:

  • ≥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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Parker Institute

Copenhagen, Denmark

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 21, 2017

First Posted

April 24, 2017

Study Start

May 8, 2017

Primary Completion

July 29, 2018

Study Completion

July 29, 2018

Last Updated

February 27, 2025

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations