Knee OsteoarthritisCANONCT06170229
Aerobic vs Neuromuscular Exercise for Knee OA
A study testing eHIIT and NEMEX-e in people with Knee Osteoarthritis, run by Frederiksberg University Hospital at 1 site in Denmark.
Trial summary
The study aims to compare the effects of an education and High Intensity Interval Training program (eHIIT) with the widely used Neuromuscular Exercise and education program (NEMEX-e) on knee OA symptoms and risk factors for cardiovascular disease in people with knee OA and at least one risk factor for developement of… 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?
- eHIIT and NEMEX-e
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Feb 2024to 12 Jun 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18- years
- Diagnosis of tibiofemoral knee OA according to the American College of Rheumatology criteria
- Radiographically confirmed diagnosis of tibiofemoral OA based on radiographs not older than 6 months.
- Average knee pain level ≥ 4 (0=No pain and 10=Worst pain) over the past week (7 days)
- At least one of following risk factors for development of cardiovascular disease:
- Body mass index ≥ 30 kg/m2
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- Hypertension (or in treatment of): Systolic ≥ 135 and/or diastolic ≥ 85 mm Hg
- Elevated HbA1c (or in treatment of): ≥ 130.7 mg/dL (44 mmol/mol)
- Elevated Triglycerides (or in treatment of): ≥ 150 mg/dL (1.7 mmol/L)
- Elevated Cholesterol (or in treatment of) (Low density lipides, LDL): LDL ≥ 54 mg/dL (3.0 mmol/L)
Who cannot join
- Contraindication to exercise (e.g., resting systolic blood pressure > 200 or diastolic blood pressure > 115, acute or reoccurring chest pain)
- Unstable body weight the last 3 months (gain/loss outside +/- 5 kg)
- Planned weight loss (non-pharmacological, pharmacological, and surgical) during study participation
- Known current cancer
- Major cardiovascular event within the last 5 years
- Insulin dependent type 1 or type 2 diabetes
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- Psoriatic, rheumatoid, or gouty arthritis disease
- Generalized pain syndromes such as fibromyalgia
- Lumbar or cervical nerve root compression syndromes
- Scheduled surgery during study participation
- Treatment with biological medication
- Impairments that prevent performance in high intensity aerobic exercise
- Current or planned participation in other health research intervention studies
- Pregnant/considering pregnancy
- Any other condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as a large knee joint effusion, uncontrolled diabetes/hypertension, psychiatric or cognitive disorders, language barriers, or opiate dependency.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effectiveness of High-intensity Aerobic Exercise and Biomechanical Neuromuscular Exercise for Treatment of Knee Osteoarthritis: A Randomised Open Label Trial
The study aims to compare the effects of an education and High Intensity Interval Training program (eHIIT) with the widely used Neuromuscular Exercise and education program (NEMEX-e) on knee OA symptoms and risk factors for cardiovascular disease in people with knee OA and at least one risk factor for developement of cardiovascular disease. The main research questions the study aims to answer are:
- Is the eHIIT program better than the NEMEX-e program for reducing the risk of cardiovascular disease?
- Are the two programs equally good at providing improvement in knee symptoms?
- Conditions
- Knee Osteoarthritis
- Being tested
- eHIIT, NEMEX-e
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eHIITBehavioural
Education and High intensity Interval Training (Aerobic Exercise)
The focus of the one educational session is rationale for aerobic exercise, expected physiological effects of aerobic exercise, diet when performing an exercise program, how the knee accommodates to exercise (including potential experience of muscle soreness and how that is different from joint pain), and management of potential knee OA symptom flares.
HIIT is an aerobic exercise form. The eHITT protocol consist of eight 2-minute intervals of high intensity training (with the goal to train at a heart rate of at least 80% of HRmax) followed by 2 minutes of moderate training intensity (with the goal to train at a heart rate of at least 60% of HRmax).
There will be several types of exercise modalities for aerobic exercise available (treadmills, cross-trainers, row- and cycle ergometers) and participants may choose whichever they prefer.
NEMEX-eBehavioural
Education and Neuromuscular Exercise
The focus of the two educational sessions is on providing knowledge of OA and treatment options to the participants, with a special focus on knee OA, diet, and exercise and its benefits. Furthermore, advice about self-management is given.
The exercises are based on neuromuscular principles to improve sensorimotor control and achieve compensatory functional stability. Sensorimotor control is the ability to coordinate muscle activity and maintain functional stability during movement allowing for joint stability during physical activity. Various positions (sitting, lying, standing) are used to achieve the desired postural activity. The overall goal is to obtain muscle control and stability in situations resembling daily life and/or more strenuous activities. The focus is on achieving good quality of the performance in each exercise with appropriate postural orientation (e.g., joint positioned appropriately in relation to each other).
| Study group | Role | What they receive |
|---|---|---|
| Education and High Intensity Interval Training (eHIIT) | Active comparator | 1 educational session lasting 1 hour. 12 weeks of supervised High Intensity Interval Training (HIIT) 3 times/week. Receives: Behavioral: eHIIT |
| Neuromuscular exercise and education program (NEMEX-e) | Active comparator | 2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week. Receives: Behavioral: NEMEX-e |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal oxygen consumption (VO2max)
Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg
Measured: Baseline and Week 12
Knee pain
The Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale (KOOS-pain), a disease-specific patient-reported instrument designed to assess knee pain in patients with knee osteoarthritis.
The KOOS-pain subscale is scored on a 0-100 scale with 100 indicating no pain and 0 indicating extreme pain.
Measured: Baseline and Week 12
Secondary outcomes (12)
Maximal oxygen consumption (VO2max)
Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg
Measured: Week 8 and week 26
Knee pain
The Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale (KOOS-pain), a disease-specific patient-reported instrument designed to assess knee pain in patients with knee osteoarthritis.
The KOOS-pain subscale is scored on a 0-100 scale with 100 indicating no pain and 0 indicating extreme pain.
Measured: Week 8 and week 26
Body Mass
Body mass measured in kilograms using a scale
Measured: Baseline, Week 12 and Week 26
Blood Pressure
Systolic and Diastolic blood pressure
Measured: Baseline, Week 12 and Week 26
Triglyceride concentration
From a blood sample
Measured: Baseline, Week 12 and Week 26
Low Density Lipids (LDL) concentration
From a blood sample
Measured: Baseline, Week 12 and Week 26
Cholesterol concentration
From a blood sample
Measured: Baseline, Week 12 and Week 26
Glucose concentration
From a blood sample
Measured: Baseline, Week 12 and Week 26
HbA1c concentration
From a blood sample
Measured: Baseline, Week 12 and Week 26
Patient Global Assessment of disease Impact
Patient-reported degree of patient's perceived impact of their knee OA on their overall life will be obtained using a 100 mm analogue scale (VAS) with anchors: 0=" No impact" and 100 = "Worst imaginable impact".
Measured: Baseline, week 8, week 12 and week 26
Physical Functioning
The Knee injury and Osteoarthritis Outcome Score (KOOS) function subscale (KOOS-function), a disease-specific patient-reported instrument designed to assess physical functioning in patients with knee osteoarthritis.
The KOOS-function subscale is scored on a 0-100 scale with 100 indicating no functional impairments and 0 indicating extreme functional impairments.
Measured: Baseline, week 8, week 12 and week 26
Health related quality of Life and physical and mental well-being (Short Form 12 (SF-12))
The 12-item short form health questionnaire (SF-12) is a measure of physical and mental health.
The physical health component is scored between 0-72. The mental health component is scored between 0-70. For both components 0 mean a worse outcome.
Measured: Baseline, week 8, week 12 and week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start23 Feb 2024
- Primary completion16 Mar 2026
- Study completion12 Jun 2026
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frederiksberg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marius Henriksen, Frederiksberg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06170229
- Sponsor's protocol ID
- PT-2023-DK-3
- Acronym
- CANO
- Status last verified
- Jun 2026
- First submitted
- 28 Nov 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of High-intensity Aerobic Exercise and Biomechanical Neuromuscular Exercise for Treatment of Knee Osteoarthritis: A Randomised Open Label Trial
- ClinicalTrials.gov ID
- NCT06170229
- Acronym / sponsor ID
- CANO / PT-2023-DK-3
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Frederiksberg University HospitalUniversity, hospital or other
- Study start
- 23 Feb 2024 (actual)
- Primary completion
- 16 Mar 2026 (actual)
- Study completion
- 12 Jun 2026 (actual)
- First posted
- 14 Dec 2023 (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.
The study aims to compare the effects of an education and High Intensity Interval Training program (eHIIT) with the widely used Neuromuscular Exercise and education program (NEMEX-e) on knee OA symptoms and risk factors for cardiovascular disease in people with knee OA and at least one risk factor for developement of cardiovascular disease. The main research questions the study aims to answer are:
- Is the eHIIT program better than the NEMEX-e program for reducing the risk of cardiovascular disease?
- Are the two programs equally good at providing improvement in knee symptoms?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education and High Intensity Interval Training (eHIIT) | Active comparator | Behavioral: eHIIT1 educational session lasting 1 hour. 12 weeks of supervised High Intensity Interval Training (HIIT) 3 times/week. |
| Neuromuscular exercise and education program (NEMEX-e) | Active comparator | Behavioral: NEMEX-e2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18- years
- Diagnosis of tibiofemoral knee OA according to the American College of Rheumatology criteria
- Radiographically confirmed diagnosis of tibiofemoral OA based on radiographs not older than 6 months.
- Average knee pain level ≥ 4 (0=No pain and 10=Worst pain) over the past week (7 days)
- At least one of following risk factors for development of cardiovascular disease:
Key exclusion criteria (15 listed)
- Contraindication to exercise (e.g., resting systolic blood pressure > 200 or diastolic blood pressure > 115, acute or reoccurring chest pain)
- Unstable body weight the last 3 months (gain/loss outside +/- 5 kg)
- Planned weight loss (non-pharmacological, pharmacological, and surgical) during study participation
- Known current cancer
- Major cardiovascular event within the last 5 years
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 |
|---|---|---|
| eHIITEducation and High intensity Interval Training (Aerobic Exercise) The focus of the one educational session is rationale for aerobic exercise, expected physiological effects of aerobic exercise, diet when performing an exercise program, how the knee accommodates to exercise (including potential experience of muscle soreness and how that is different from joint pain), and management of potential knee OA symptom flares. HIIT is an aerobic exercise form. The eHITT protocol consist of eight 2-minute intervals of high intensity training (with the goal to train at a heart rate of at least 80% of HRmax) followed by 2 minutes of moderate training intensity (with the goal to train at a heart rate of at least 60% of HRmax). There will be several types of exercise modalities for aerobic exercise available (treadmills, cross-trainers, row- and cycle ergometers) and participants may choose whichever they prefer. | Behavioural | Education and High Intensity Interval Training (eHIIT) |
| NEMEX-eEducation and Neuromuscular Exercise The focus of the two educational sessions is on providing knowledge of OA and treatment options to the participants, with a special focus on knee OA, diet, and exercise and its benefits. Furthermore, advice about self-management is given. The exercises are based on neuromuscular principles to improve sensorimotor control and achieve compensatory functional stability. Sensorimotor control is the ability to coordinate muscle activity and maintain functional stability during movement allowing for joint stability during physical activity. Various positions (sitting, lying, standing) are used to achieve the desired postural activity. The overall goal is to obtain muscle control and stability in situations resembling daily life and/or more strenuous activities. The focus is on achieving good quality of the performance in each exercise with appropriate postural orientation (e.g., joint positioned appropriately in relation to each other). | Behavioural | Neuromuscular exercise and education program (NEMEX-e) |
Primary outcome
Maximal oxygen consumption (VO2max)
Time frame: Baseline and Week 12
Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg
Knee pain
Time frame: Baseline and Week 12
The Knee injury and Osteoarthritis Outcome Score (KOOS) pain subscale (KOOS-pain), a disease-specific patient-reported instrument designed to assess knee pain in patients with knee osteoarthritis. The KOOS-pain subscale is scored on a 0-100 scale with 100 indicating no pain and 0 indicating extreme pain.
12 secondary outcomes
Maximal oxygen consumption (VO2max)
Time frame: Week 8 and week 26
Knee pain
Time frame: Week 8 and week 26
Body Mass
Time frame: Baseline, Week 12 and Week 26
Blood Pressure
Time frame: Baseline, Week 12 and Week 26
Triglyceride concentration
Time frame: Baseline, Week 12 and Week 26
Low Density Lipids (LDL) concentration
Time frame: Baseline, Week 12 and Week 26
Cholesterol concentration
Time frame: Baseline, Week 12 and Week 26
Glucose concentration
Time frame: Baseline, Week 12 and Week 26
HbA1c concentration
Time frame: Baseline, Week 12 and Week 26
Patient Global Assessment of disease Impact
Time frame: Baseline, week 8, week 12 and week 26
Physical Functioning
Time frame: Baseline, week 8, week 12 and week 26
Health related quality of Life and physical and mental well-being (Short Form 12 (SF-12))
Time frame: Baseline, week 8, week 12 and week 26
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 16 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eHIIT and NEMEX-e in people with Knee Osteoarthritis, run by Frederiksberg University Hospital at 1 site 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 10 inclusion and 15 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 16 Jun 2026. 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 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?
Maximal oxygen consumption (VO2max) (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. 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 16 Jun 2026; AzTrials last refreshed its copy on 3 Nov 2026.