Osteoarthritis, KneeNCT04857879
Implementation of GLA:D Program in West Virginians With Osteoarthritis of the Knee
A study testing GLA:D program (Good Life with osteoArthritis in Denmark) in people with Osteoarthritis, Knee, run by Marshall University at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 45 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- GLA:D program (Good Life with osteoArthritis in Denmark)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2021to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
School of Physical Therapy, Marshall University
Huntington, West Virginia, 25705
Saurabh P Mehta, PhD
About this study
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
This study will examine feasibility of implementing Good Life with Osteoarthritis in Denmark (GLA:D) program in West Virginians with osteoarthritis of the knee
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- GLA:D program (Good Life with osteoArthritis in Denmark)
- Keywords
- knee arthritis, Good Life with Osteoarthritis in Denmark, neuromuscular exercises
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLA:D program (Good Life with osteoArthritis in Denmark)Other
Also called Control intervention
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.
| Study group | Role | What they receive |
|---|---|---|
| Good Life with Osteoarthritis (GLA:D) Program | Experimental | 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. Receives: Other: GLA:D program (Good Life with osteoArthritis in Denmark) |
| Control intervention group | Active comparator | 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. Receives: Other: GLA:D program (Good Life with osteoArthritis in Denmark) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start6 Aug 2021
- Primary completionJun 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marshall University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University of Southern Denmark
- Responsible party
- Principal investigator, Saurabh, Marshall University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04857879
- Sponsor's protocol ID
- 1544552
- Status last verified
- Aug 2021
- First submitted
- 20 Apr 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04857879
- Acronym / sponsor ID
- 1544552
- Conditions
- Osteoarthritis, Knee
- Keywords
- knee arthritis, Good Life with Osteoarthritis in Denmark, neuromuscular exercises
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Marshall UniversityUniversity, hospital or other
- Collaborators
- University of Toronto, University of Southern Denmark
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Good Life with Osteoarthritis (GLA:D) Program | Experimental | Other: GLA:D program (Good Life with osteoArthritis in Denmark)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. |
| Control intervention group | Active comparator | Other: GLA:D program (Good Life with osteoArthritis in Denmark)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. |
Who may qualify
- Ages
- 45 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLA:D program (Good Life with osteoArthritis in Denmark)Also: Control interventionGLA: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. | Other | Control intervention group, Good Life with Osteoarthritis (GLA:D) Program |
Primary outcome
Change in Knee injury and Osteoarthritis Outcome Score (KOOS4) scores from baseline to 12-weeks later
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLA:D program (Good Life with osteoArthritis in Denmark) in people with Osteoarthritis, Knee, run by Marshall University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Saurabh P Mehta (3046965620, mehtas@marshall.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knee injury and Osteoarthritis Outcome Score (KOOS4) scores from baseline to 12-weeks later (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.