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

Osteoarthritis, Knee Clinical Trial

Official title:

A Pilot Randomized Controlled Trial to Assess the Implementation and Outcomes of Good Life With Osteoarthritis (GLA:D) Program in West Virginians Suffering From the Osteoarthritis of the Knee

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04857879
• Other study ID #: 1544552
• Status: Recruiting
• Phase: N/A
• Start date: August 6, 2021
• Est. completion date: July 2022

Study information

• Verified date: August 2021
• Source: Marshall University
• Contact: Saurabh P Mehta
• Phone: 3046965620
• Email: mehtas[@]marshall.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: July 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• GLA:D program (Good Life with osteoArthritis in Denmark)
GLA:D includes disease-specific education combined with neuromuscular exercises. Control interventions include disease-specific education combined with exercises to optimize movement and strength of the affected knee.

Locations

Country	Name	City	State
United States	School of Physical Therapy, Marshall University	Huntington	West Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Marshall University	University of Southern Denmark, University of Toronto

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Knee injury and Osteoarthritis Outcome Score (KOOS4) scores from baseline to 12-weeks later	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.	12-weeks