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

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

GLA:D program (Good Life with osteoArthritis in Denmark)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring knee arthritis, Good Life with Osteoarthritis in Denmark, neuromuscular exercises

Eligibility Criteria

45 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Between 45 to 90 years of age,
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
Recommendation by an orthopedic surgeon to pursue conservative management of KOA.

Exclusion Criteria:

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

Sites / Locations

School of Physical Therapy, Marshall UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Good Life with Osteoarthritis (GLA:D) Program

Control intervention group

Arm Description

Participants will attend 2 sessions aimed at providing disease-specific education followed by 12 sessions of neuromuscular exercises, each 1 hour in length, delivered twice a week over 6 weeks.

Participants allocated to the control intervention will receive disease-specific education and training to learn home exercises in a 1-hour group session. They will receive a booster session 4-weeks after the first session.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04857879

First Posted

April 20, 2021

Last Updated

August 30, 2021

Sponsor

Marshall University

Collaborators

University of Toronto, University of Southern Denmark

1. Study Identification

Unique Protocol Identification Number

NCT04857879

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Unknown status

Study Start Date

August 6, 2021 (Actual)

Primary Completion Date

June 2022 (Anticipated)

Study Completion Date

July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Marshall University

Collaborators

University of Toronto, University of Southern Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

knee arthritis, Good Life with Osteoarthritis in Denmark, neuromuscular exercises

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Good Life with Osteoarthritis (GLA:D) Program

Arm Type

Experimental

Arm Description

Participants will attend 2 sessions aimed at providing disease-specific education followed by 12 sessions of neuromuscular exercises, each 1 hour in length, delivered twice a week over 6 weeks.

Arm Title

Control intervention group

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

GLA:D program (Good Life with osteoArthritis in Denmark)

Other Intervention Name(s)

Control intervention

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Knee injury and Osteoarthritis Outcome Score (KOOS4) scores from baseline to 12-weeks later

Description

Time Frame

12-weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Between 45 to 90 years of age, 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 Recommendation by an orthopedic surgeon to pursue conservative management of KOA. Exclusion Criteria: Prior joint replacement surgery in the ipsilateral knee, Known history of cognitive impairments or any neurodegenerative disease, Any other neurological or musculoskeletal pathologies that have resulted in permanent mobility deficits or functional impairments, Medical conditions that would preclude them from participating in exercise programs, and Inability to read and comprehend English.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Saurabh P Mehta

Phone

3046965620

mehtas@marshall.edu

Facility Information:

Facility Name

School of Physical Therapy, Marshall University

City

Huntington

State/Province

West Virginia

ZIP/Postal Code

25705

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Saurabh P Mehta, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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