Knee OsteoarthritisNCT04437134
On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
An observational study of Knee Osteoarthritis, run by Slagelse Hospital at 4 sites in Denmark.
Trial summary
Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many on-site health care services are unavailable. This study seeks to investigate the relative effectiveness of an alternative on-line delivery model of exercise and education compared to on-site delivery in patients with knee… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- On-line exercise and education and On-site exercise and education
- How many people
- 3,789 participants
- Where
- 4 sitesDenmark
- Study dates
- 12 Jun 2020to 14 Jun 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients included into this study are adults, reporting knee OA symptoms as their main source of pain. Both study groups (on-line and on-site exercise and education) are comprised of patients with symptomatically verified (all) and radiographically verified (most) knee OA. On-line exercise and education: Patients referred for assessment in secondary care due to knee OA symptoms. On-site exercise and education: Patients with knee OA symptoms referred to a physiotherapist either by their general practitioner, by an orthopedic surgeon, or by self-referral.
Who may be able to join
- Knee OA symptoms resulting in contact with the health care system
Who cannot join
- Another reason than OA for the problems; includes tumour or inflammatory joint disease
- Other symptoms that are more pronounced than the OA symptoms; i.e. chronic, generalised pain or fibromyalgia.
- In addition, for the on-line study group:
- Previous participation in similar exercise and education programs (i.e. the on-site version)
- Lack of necessary equipment or skills to administer on-line participation
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Department of Orthopedic Surgery, Næstved-Slagelse-Ringsted Hospitals
Næstved, Region Sjælland, 4700
Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals
Næstved, Region Sjælland, 4700
University of Southern Denmark
Odense, Region Southern Denmark, 5230
Department of Physiotherapy and Occupational Therapy, Næstved-Slagelse-Ringsted Hospitals
Slagelse, Region Sjælland, 4200
About this study
Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many on-site health care services are unavailable. This study seeks to investigate the relative effectiveness of an alternative on-line delivery model of exercise and education compared to on-site delivery in patients with knee osteoarthritis.
Read the detailed description
Due to the extraordinary events of the 2020 COVID-19 pandemic, finding alternative delivery-models of treatment has come to the forefront of public health services worldwide. Consequently, on-line treatment is rapidly becoming an integral part of public health service. For patients with knee osteoarthritis (OA), where non-pharmacological and non-surgical treatment is considered first-line treatment, on-line delivered exercise has already shown promise and may be a viable treatment option, especially when traditional on-site exercise delivery models are unavailable. However, further studies are needed to clarify the relative effectiveness of on-line exercise and education when compared to on-site exercise and education programs.
This study aims to evaluate the effects of on-line exercise and education in knee OA compared to a cohort of similar knee OA patients completing the same exercise and education program through on-site delivery.
This study includes two cohorts of knee OA patients receiving the same exercise and education program through different delivery models (on-line vs. on-site). The on-line cohort is a new treatment delivery initiative, born out of the COVID-19 enforced shutdown of all non-critical on-site health care. The on-site cohort is comprised of knee OA patients from a patient registry, collecting outcome data as part of the exercise and education program.
The exercise and education program is called Good Life with osteoArthritis in Denmark (GLA:D), and consists of two to three disease-specific educational sessions and 12 neuromuscular exercise sessions (NEMEX-TJR). GLA:D originates from Denmark and has currently been implemented in Australia, Canada, China, Switzerland and New Zealand.
This study will primarily compare outcomes of pain, function and quality of life between the two different treatment delivery models and will provide important insights in effectiveness of alternative delivery models of recommended first-line care for patients with knee OA.
- Conditions
- Knee Osteoarthritis
- Being tested
- On-line exercise and education, On-site exercise and education
- Keywords
- Knee, Osteoarthritis, Exercise, Education, On-line, Pain, Function, Quality of Life
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
On-line exercise and educationOther
Exercise:
Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. Patients are instructed in how to use alternative equipment at home for each exercise if necessary prior to the first on-line exercise session.
Education:
Patients attend two to three on-line educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.
On-site exercise and educationOther
Exercise:
Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. The exercise sessions are delivered at physiotherapy clinics in Denmark.
Education:
Patients attend two to three on-site educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment.
| Study group | Role | What they receive |
|---|---|---|
| On-line exercise and education | Exercise (12 sessions) and education (2-3 sessions) delivered on-line. Patients attend both the exercise and educational sessions by logging on to virtual rooms using links sent out by e-mail. The sessions are led and supervised by GLA:D certified physiotherapists. Receives: Other: On-line exercise and education | |
| On-site exercise and education | Exercise (12 sessions) and education (2-3 sessions) delivered on-site. Patients attend both the exercise and educational sessions at physiotherapy clinics in Denmark. The sessions are led and supervised by GLA:D certified physiotherapists. Receives: Other: On-site exercise and education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee impact summary
Summary score from the Knee injury and Osteoarthritis Outcome Score, short version (KOOS 12). The summary score is calculated as the average score from the KOOS 12 subscales pain, function and quality of life (QOL), ranging from 0 (worst) to 100 (best).
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Secondary outcomes (7)
Fast-paced walking ability
Fast-paced walking ability is recorded by the physiotherapists and evaluated using the 40-m fast-paced walk test.
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
Chair-stand ability
Chair-stand ability is recorded by the physiotherapists and evaluated using the 30-s chair-stand test.
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
Self-reported function
Patients self-report of function during daily life using the subscale function from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Self-reported pain
Patients self-report of pain using the subscale pain from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Self-reported quality of life
Patients self-report of quality of life using the subscale quality of life from the KOOS 12 questionnaire with scores ranging from 0 (worst) to 100 (best).
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Pain intensity
Mean pain intensity during the last week in the most affected knee is evaluated on a 100 mm visual analogue scale (VAS) with terminal descriptors of 'no pain' (0 mm) and 'maximum pain' (100 mm).
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Physical activity and exercise
Patients self-report of time spent (frequency and duration) on structured physical activity and exercise.
Measured: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start12 Jun 2020
- Primary completion10 Jul 2021
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 3,789 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Slagelse Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Zealand
- Responsible party
- Principal investigator, Pætur Mikal Holm, Slagelse Hospital
- Investigators
- Pætur M Holm, PhD, Principal investigator, Department of Physiotherapy and Occupational TherapySøren T Skou, Professor, Study chair, Department of Physiotherapy and occupational Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437134
- Sponsor's protocol ID
- SlagelseH
- Other IDs
- J.nr. 20-000013
- Status last verified
- Apr 2023
- First submitted
- 7 Jun 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- On-line Neuromuscular Exercise and Education for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04437134
- Acronym / sponsor ID
- SlagelseH
- Conditions
- Knee Osteoarthritis
- Keywords
- Knee, Osteoarthritis, Exercise, Education, On-line, Pain, Function, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,789 participants (actual)
- Lead sponsor
- Slagelse HospitalUniversity, hospital or other
- Collaborators
- Region Zealand
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 10 Jul 2021 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 18 Jun 2020 (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.
Due to enforced social distancing as a direct consequence of the COVID-19 pandemic, many on-site health care services are unavailable. This study seeks to investigate the relative effectiveness of an alternative on-line delivery model of exercise and education compared to on-site delivery in patients with knee osteoarthritis.
Detailed description
Due to the extraordinary events of the 2020 COVID-19 pandemic, finding alternative delivery-models of treatment has come to the forefront of public health services worldwide. Consequently, on-line treatment is rapidly becoming an integral part of public health service. For patients with knee osteoarthritis (OA), where non-pharmacological and non-surgical treatment is considered first-line treatment, on-line delivered exercise has already shown promise and may be a viable treatment option, especially when traditional on-site exercise delivery models are unavailable. However, further studies are needed to clarify the relative effectiveness of on-line exercise and education when compared to on-site exercise and education programs.
This study aims to evaluate the effects of on-line exercise and education in knee OA compared to a cohort of similar knee OA patients completing the same exercise and education program through on-site delivery.
This study includes two cohorts of knee OA patients receiving the same exercise and education program through different delivery models (on-line vs. on-site). The on-line cohort is a new treatment delivery initiative, born out of the COVID-19 enforced shutdown of all non-critical on-site health care. The on-site cohort is comprised of knee OA patients from a patient registry, collecting outcome data as part of the exercise and education program.
The exercise and education program is called Good Life with osteoArthritis in Denmark (GLA:D), and consists of two to three disease-specific educational sessions and 12 neuromuscular exercise sessions (NEMEX-TJR). GLA:D originates from Denmark and has currently been implemented in Australia, Canada, China, Switzerland and New Zealand.
This study will primarily compare outcomes of pain, function and quality of life between the two different treatment delivery models and will provide important insights in effectiveness of alternative delivery models of recommended first-line care for patients with knee OA.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-line exercise and education | – | Other: On-line exercise and educationExercise (12 sessions) and education (2-3 sessions) delivered on-line. Patients attend both the exercise and educational sessions by logging on to virtual rooms using links sent out by e-mail. The sessions are led and supervised by GLA:D certified physiotherapists. |
| On-site exercise and education | – | Other: On-site exercise and educationExercise (12 sessions) and education (2-3 sessions) delivered on-site. Patients attend both the exercise and educational sessions at physiotherapy clinics in Denmark. The sessions are led and supervised by GLA:D certified physiotherapists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients included into this study are adults, reporting knee OA symptoms as their main source of pain. Both study groups (on-line and on-site exercise and education) are comprised of patients with symptomatically verified (all) and radiographically verified (most) knee OA. On-line exercise and education: Patients referred for assessment in secondary care due to knee OA symptoms. On-site exercise and education: Patients with knee OA symptoms referred to a physiotherapist either by their general practitioner, by an orthopedic surgeon, or by self-referral.
Key inclusion criteria (1 listed)
- Knee OA symptoms resulting in contact with the health care system
Key exclusion criteria (5 listed)
- Another reason than OA for the problems; includes tumour or inflammatory joint disease
- Other symptoms that are more pronounced than the OA symptoms; i.e. chronic, generalised pain or fibromyalgia.
- Previous participation in similar exercise and education programs (i.e. the on-site version)
- Lack of necessary equipment or skills to administer on-line participation
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 |
|---|---|---|
| On-line exercise and educationExercise: Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. Patients are instructed in how to use alternative equipment at home for each exercise if necessary prior to the first on-line exercise session. Education: Patients attend two to three on-line educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment. | Other | On-line exercise and education |
| On-site exercise and educationExercise: Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. The exercise sessions are delivered at physiotherapy clinics in Denmark. Education: Patients attend two to three on-site educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment. | Other | On-site exercise and education |
Primary outcome
Knee impact summary
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Summary score from the Knee injury and Osteoarthritis Outcome Score, short version (KOOS 12). The summary score is calculated as the average score from the KOOS 12 subscales pain, function and quality of life (QOL), ranging from 0 (worst) to 100 (best).
7 secondary outcomes
Fast-paced walking ability
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
Chair-stand ability
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months)
Self-reported function
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Self-reported pain
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Self-reported quality of life
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Pain intensity
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Physical activity and exercise
Time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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.
Pætur M Holm, PhD principal investigator
Department of Physiotherapy and Occupational Therapy
Søren T Skou, Professor study chair
Department of Physiotherapy and occupational Therapy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by Slagelse Hospital at 4 sites in Denmark.
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 1 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: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee impact summary (time frame: Primary follow-up point: Change from baseline to completion of GLA:D program (an average of three months). Secondary follow-up point: 12 months). 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 12 Apr 2023.