An interventional study of eHIIT and NEMEX-e in Knee Osteoarthritis, sponsored by Frederiksberg University Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by Frederiksberg University Hospital · Not applicable, Interventional, and Treatment
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:
3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.
This study's enrollment of 150 is above the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Frederiksberg University Hospital is the lead sponsor of 40 studies on the registry; 1 is open to participants now.
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At least one of following risk factors for development of cardiovascular disease:
Exclusion Criteria:
1 educational session lasting 1 hour. 12 weeks of supervised High Intensity Interval Training (HIIT) 3 times/week.
Behavioral: eHIIT
2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week.
Behavioral: NEMEX-e
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.
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).
Maximal oxygen consumption (VO2max)
Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg
Time frame: 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.
Time frame: Baseline and Week 12
Maximal oxygen consumption (VO2max)
Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg
Time frame: 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.
Time frame: Week 8 and week 26
Body Mass
Body mass measured in kilograms using a scale
Time frame: Baseline, Week 12 and Week 26
Blood Pressure
Systolic and Diastolic blood pressure
Time frame: Baseline, Week 12 and Week 26
Triglyceride concentration
From a blood sample
Time frame: Baseline, Week 12 and Week 26
Low Density Lipids (LDL) concentration
From a blood sample
Time frame: Baseline, Week 12 and Week 26
Cholesterol concentration
From a blood sample
Time frame: Baseline, Week 12 and Week 26
Glucose concentration
From a blood sample
Time frame: Baseline, Week 12 and Week 26
HbA1c concentration
From a blood sample
Time frame: 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".
Time frame: 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.
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))
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.
Time frame: Baseline, week 8, week 12 and week 26
Knee-related Quality of Life
The Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale (KOOS-QoL), a disease-specific patient-reported instrument designed to assess knee-related quality of life in patients with knee osteoarthritis. The KOOS-QoL subscale is scored on a 0-100 scale with 100 indicating best possible knee-related quality of life and 0 indicating worst possible knee-related quality of life.
Time frame: Baseline, week 8, week 12 and week 26
Knee Symptoms
The Knee injury and Osteoarthritis Outcome Score (KOOS) symptoms subscale (KOOS-symptoms), a disease-specific patient-reported instrument designed to knee symptoms in patients with knee osteoarthritis. KOOS-symptom is scored on a 0-100 scale with indicating no symptoms and 0 indicating worst possible symptoms.
Time frame: Baseline, week 8, week 12 and week 26
Knee Function in Sports and Recreational activities
The Knee injury and Osteoarthritis Outcome Score (KOOS) Sports and Recreation subscale (KOOS-Sports/Recreation), a disease-specific patient-reported instrument designed to knee symptoms in patients with knee osteoarthritis. KOOS-Sports/Recreation is scored on a 0-100 scale with indicating no symptoms and 0 indicating worst possible symptoms.
Time frame: Baseline, week 8, week 12 and week 26
The World Health Organisation - Five Well-Being Index (WHO-5)
Patient reported mental well-being will be obtained with the The World Health Organisation 5-Well-Being Index consisting of five questions each scored on a 0 to 5 scale. Raw score: 0 represents worst possible well-being and 25 represents best possible well-being. Percentage score: 0 represents worst possible well-being and 100 represents best possible well-being.
Time frame: Baseline, week 8, week 12 and week 26
OMERACT-OARSI treatment responder criteria
A classification of patients as a positive responder based on the Outcome Measures in Rheumatology (OMERACT) and Osteoarthritis Research Society International (OARSI) (OMERACT-OARSI) responder criteria that classifies patients according to improvements in pain (co-primary outcome),function (secondary outcome) and patient global assessment (secondary outcome). Each participant is classified as either a "responder" or a "non-responder" at each of the post-baseline follow-ups.
Time frame: Baseline, week 8, week 12 and week 26
Sleep quality using the global Single-item sleep quality scale (SQS)
Sleep quality will be obtained with the global Single-item sleep quality scale (SQS). SQS is scored on 0-10 scale with 0 representing worst possible sleep quality and 10 representing best possible sleep quality.
Time frame: Baseline, week 8, week 12 and week 26
Nightly pain
Self-reported pain during the night is obtained on a 0-2 scale with 0=No nightly pain, 1=pain at movement or in certain positions, and 2=Pain even without movement.
Time frame: Baseline, week 8, week 12 and week 26
Maximal aerobic capacity (VO2 peak) during a cardiopulmonary exercise test
A cardiopulmonary exercise test will be used to assess maximal aerobic capacity (VO2peak) measured in ml/min/kg.
Time frame: Baseline, week 8, week 12 and week 26
Maximum work during a cardiopulmonary exercise test
The maximal work during the cardiopulmonary exercise test measured in Watts (W)
Time frame: Baseline, week 8, week 12 and week 26
Respiratory exchange ratio (RER) during a cardiopulmonary exercise test
The respiratory exchange ratio (RER) during the cardiopulmonary exercise test is calculated as the ratio of carbon-dioxide production (VCO2) and oxygen consumption (VO2)
Time frame: Baseline, week 8, week 12 and week 26
Maximal hear rate during a cardiopulmonary exercise test
The maximal heart rate during a cardiopulmonary exercise test is recorded as beats/min.
Time frame: Baseline, week 8, week 12 and week 26
Lean body mass from a dual x-ray absorptiometry scan
Dual x-ray absorptiometry (DXA) will be used to assess lean body mass
Time frame: Baseline, Week 12 and Week 26
Total fat mass from a dual x-ray absorptiometry scan
Dual x-ray absorptiometry (DXA) will be used to assess total fat mass.
Time frame: Baseline, Week 12 and Week 26
Bone mineral density from a dual x-ray absorptiometry scan
Dual x-ray absorptiometry (DXA) will be used to assess bone density.
Time frame: Baseline, Week 12 and Week 26
Hip and waist circumstance
The measurements are recorded in cm and measured during a clinical examination using a measurement tape and standardized procedures
Time frame: Baseline, Week 12 and Week 26
Leg extensor power
Muscle power (force × velocity) of the lower limb of the target knee will be assessed using the Nottingham power rig. In a seated position, the participants will be instructed to push with a single leg against a plate at maximal effort/force.
Time frame: Baseline, Week 12 and Week 26
Analgesics usage
The participants' use of over-the-counter paracetamol and ibuprofen will be recorded during an interview with an investigator.
Time frame: Baseline, Week 12 and Week 26
Pressure pain sensitivity
A hand-held pressure algometer will used to assess pressure pain thresholds (PPTs). Pressure will be applied at a rate of approximately 30 kilopascal per second (kPa/s), with a 1 cm2 probe. All participants are instructed to push a button when they feel that the pressure becomes just barely painful. PPTs from the medial tibiofemoral joint space on the target knee and the contralateral elbow will be assessed
Time frame: Baseline, Week 12 and Week 26
C-reactive protein concentration
From a blood sample
Time frame: Baseline, Week 12 and Week 26
Interleukin 6 (IL6) concentration
From a blood sample
Time frame: Baseline, Week 12 and Week 26
Seismocardiography - estimate of maximal oxygen consumption (VO2max) during rest.
Seismocardiography (SCG) is a technique for non-invasive evaluation of cardiac activity through the measurement of precordial vibrations using an accelerometer. SCG is performed by mounting a 3-axis accelerometer on the skin covering the sternum with double adhesive tape. The measurement is performed with the participant lying in the supine position after 5 minutes of rest. The 3-dimensional accelerations are recorded and used together with age, sex, body weight and height in an algorithm to estimate cardiorespiratory function (VO2max) at rest. NOTE: This outcome is added to the protocol after recruitment was started and will therefore only be measured on a subset of participants (participants enrolled after August 15, 2024).
Time frame: Baseline, Week 12 and Week 26
Plan to share: Yes
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
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Frederiksberg University Hospital