Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
150 participants
INTERVENTIONAL
2024-02-23
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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?
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EXercise as TReatment for osteoArthritis
NCT03215602
Neuromuscular Training Program in Patients With Knee OA (Osteoarthritis)
NCT06270329
Effects of Exercise and Education in Patients With Chronic Pain After Total Knee Replacement
NCT03886259
Progressive Resistance Training Compared to Neuromuscular Exercise in Patients With Hip Osteoarthritis
NCT04714047
The Effect of Telerehabilitation-Based Exercise and Training on Outcome Measures in Patients With Knee Osteoarthritis
NCT05209893
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Education and High Intensity Interval Training (eHIIT)
1 educational session lasting 1 hour. 12 weeks of supervised High Intensity Interval Training (HIIT) 3 times/week.
eHIIT
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.
Neuromuscular exercise and education program (NEMEX-e)
2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week.
NEMEX-e
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).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
eHIIT
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-e
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).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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)
Exclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Frederiksberg University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marius Henriksen
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Parker Institute, Frederiksberg Hospital
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Marius Henriksen, PhD
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PT-2023-DK-3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.