Implementation of GLA:D Program in West Virginians With Osteoarthritis of the Knee
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
1 other identifier
interventional
24
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2021
1 active site
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
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
April 23, 2021
CompletedStudy Start
First participant enrolled
August 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedSeptember 5, 2021
August 1, 2021
10 months
April 20, 2021
August 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Good Life with Osteoarthritis (GLA:D) Program
EXPERIMENTALParticipants 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.
Control intervention group
ACTIVE COMPARATORParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Marshall Universitylead
- University of Torontocollaborator
- University of Southern Denmarkcollaborator
Study Sites (1)
School of Physical Therapy, Marshall University
Huntington, West Virginia, 25705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, School of Physical Therapy
Study Record Dates
First Submitted
April 20, 2021
First Posted
April 23, 2021
Study Start
August 6, 2021
Primary Completion
June 1, 2022
Study Completion
July 1, 2022
Last Updated
September 5, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share