Aerobic Vs Neuromuscular Exercise for Knee OA

NCT06170229 | Recruiting

• 1 other identifier: PT-2023-DK-3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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?

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (2)

• Maximal oxygen consumption (VO2max)

  Cardiopulmonary exercise test (CPET) on an ergometer bicycle for evaluation maximal oxygen consumption (VO2max) measured in ml/min/kg

  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.

  Baseline and Week 12

Secondary Outcomes (12)

• Maximal oxygen consumption (VO2max)

  Week 8 and week 26

• Knee pain

  Week 8 and week 26

• Body Mass

  Baseline, Week 12 and Week 26

• Blood Pressure

  Baseline, Week 12 and Week 26

• Triglyceride concentration

  Baseline, Week 12 and Week 26

Other Outcomes (21)

• Knee-related Quality of Life

  Baseline, week 8, week 12 and week 26

• Knee Symptoms

  Baseline, week 8, week 12 and week 26

• Knee Function in Sports and Recreational activities

  Baseline, week 8, week 12 and week 26

Study Arms (2)

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.

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.

Behavioral: NEMEX-e

Interventions

eHIIT BEHAVIORAL

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 High Intensity Interval Training (eHIIT)

NEMEX-e BEHAVIORAL

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).

Neuromuscular exercise and education program (NEMEX-e)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Frederiksberg University Hospital: lead

Study Sites (1)

The Parker Institute, Frederiksberg Hospital

Copenhagen, 2000, Denmark

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Marius Henriksen, PhD

CONTACT

+4538164160; marius.henriksen@regionh.dk

Cecilie Bartholdy

CONTACT

+4538164161; Cecilie.Roedgaard.Bartholdy@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 14, 2023
• Study Start: February 23, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 5, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

DK (1)