Implementation of GLA:D Program in West Virginians With Osteoarthritis of the Knee

Not Applicable

• Conditions: Osteoarthritis, Knee

• Registration Number: NCT04857879
• Lead Sponsor: Marshall University

Brief Summary

This study will examine feasibility of implementing Good Life with Osteoarthritis in Denmark (GLA:D) program in West Virginians with osteoarthritis of the knee

Detailed Description

Using West Virginia (WV) as an implementation site, this study will examine the feasibility of process implementation and effectiveness of the Good Life with Osteoarthritis in Denmark (GLA:D) program in individuals with osteoarthritis of the knee (KOA). Specifically, the study will examine the feasibility and acceptability of the GLA:D program in individuals with KOA. This study will also assess the magnitude of changes in self-reported knee pain and functional impairments as well as physical performance in individuals who receive GLA:D compared to those who receive control interventions consisting of disease-specific education and exercises for KOA.

Study Timeline

• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-20
• Study First Posted: 2021-04-23
• Status Verified: 2021-08
• Study Start: 2021-08-06
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-09-05
• Primary Completion: 2022-06
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Between 45 to 90 years of age,
2. Osteoarthritis of the knee (KOA) (Kellgren and Lawrence grade 2, 3, or 4) confirmed by an orthopedic surgeon based on plain film radiographs and symptoms, and
3. Recommendation by an orthopedic surgeon to pursue conservative management of KOA.

Exclusion Criteria

1. Prior joint replacement surgery in the ipsilateral knee,
2. Known history of cognitive impairments or any neurodegenerative disease,
3. Any other neurological or musculoskeletal pathologies that have resulted in permanent mobility deficits or functional impairments,
4. Medical conditions that would preclude them from participating in exercise programs, and
5. Inability to read and comprehend English.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Knee injury and Osteoarthritis Outcome Score (KOOS4) scores from baseline to 12-weeks later	12-weeks	The KOOS4 is a variant of full length KOOS that has all subscales of full length KOOS (pain, symptoms, ADL, and QOL) except sports and recreation activities subscale. There are 9 items in the pain subscale, 7 items in the symptom subscale, 17 items in the ADL subscale, and 4 items in the QOL subscale. The items across these subscales are scored on the scale of 0 to 4 where 0 indicates no problem and 4 indicates an extreme problem. Each subscale has sufficient stability and dimensionality, and therefore the score for each subscale is calculated independently on 0-100 interval with 0 indicating an extreme problem and 100 indicating no problems.

Trial Locations

Locations (1)

School of Physical Therapy, Marshall University; 🇺🇸 Huntington, West Virginia, United States