Comparative Effectiveness of High-intensity Aerobic Exercise and Biomechanical Neuromuscular Exercise for Treatment of Knee Osteoarthritis: a Randomised Open Label Trial

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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?

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

⁃ 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)

Locations
Other Locations
Denmark
The Parker Institute, Frederiksberg Hospital
RECRUITING
Copenhagen
Contact Information
Primary
Marius Henriksen, PhD
marius.henriksen@regionh.dk
+4538164160
Backup
Cecilie Bartholdy
Cecilie.Roedgaard.Bartholdy@regionh.dk
+4538164161
Time Frame
Start Date: 2024-02-23
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Active_comparator: 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.
Active_comparator: Neuromuscular exercise and education program (NEMEX-e)
2 educational sessions lasting 1 hour each. 8 weeks of supervised Neuromuscular Exercise 2 times/week.
Related Therapeutic Areas
Sponsors
Leads: Frederiksberg University Hospital

This content was sourced from clinicaltrials.gov