EXercise as TReatment for osteoArthritis

NCT03215602 | Completed DMC

• 1 other identifier: SJ-517
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) of the knee is a chronic musculoskeletal disease, and a major cause of pain and disability worldwide. Exercise has previously demonstrated good effect in alleviating OA symptoms. However, optimal exercise modes in OA are currently unknown. This study seeks to evaluate the effects of supplementary focused, knee extensor strength training in addition to neuromuscular exercise (NEMEX) and education in people with OA of the knee as performed in Good Life with osteoArthritis in Denmark (GLA:D ᵀᴹ). Through a randomized design, study participants will either be allocated to 12 weeks (twice weekly) of NEMEX and education or 12 weeks (twice weekly) of NEMEX and education and focused, knee extensor strength training. The primary outcome measurement for this study is the Knee injury and Osteoarthritis Outcome Score, subscale Activities of Daily Living (KOOS-ADL), which is a self-reported questionnaire on daily life activities. Other outcomes include parameters of maximal muscle strength and muscle power, muscle imaging, physical function, pain and self-reported health status.

Conditions

Knee Osteoarthritis

Keywords

knee; osteoarthritis; exercise; quadriceps; strength; activities of daily living; treatment outcome

Outcome Measures

Primary Outcomes (1)

• Knee injury and Osteoarthritis Outcome Score (KOOS) - subscale Activities of daily living (ADL)

  KOOS is a validated and extensively used self-reported outcome measure for people with knee OA. KOOS consists of five subscales, of which the subscale KOOS-ADL will be the primary outcome for this study. KOOS-ADL consists of 17 questions, which are answered on a 4-point likert scale (0=no problems, 4=extreme problems). KOOS-ADL has demonstrated a test-retest reliability (ICC) of 0.84-0.94 as well as demonstrating responsiveness to change following physical therapy in knee osteoarthritis.

  Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.

Secondary Outcomes (5)

• Muscle power (watt/kg. bodyweight)

  Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: Baseline to 6 weeks.

• Functional performance (40 m walk & stair-climbs)

  Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: 6 weeks.

• Pain medication

  Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.

• KOOS (remaining four subscales)

  Primary endpoint: Change from baseline to 12 weeks. Secondary endpoints: 6 weeks & 12 months.

• AE (adverse events) & Serious Adverse Events (SAE)

  Primary endpoint: From baseline to 12 weeks.. Secondary endpoint: 12 months.

Other Outcomes (14)

• Pain sensitization

  Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: 6 weeks.

• MRI derived muscle quality assessment

  Primary endpoint: Change from baseline to 12 weeks.

• Knee extensor isokinetic dynamometry

  Primary endpoint: Change from baseline to 12 weeks. Secondary endpoint: 6 weeks.

Study Arms (2)

NEMEX and education + strength training

EXPERIMENTAL

Participants will undergo 12 weeks of twice weekly exercise. Each exercise session will last for 70-90 min. and will consist of 1 hour of specific exercises to optimize sensorimotor control and achieve compensatory functional stability performed in a multiple-joint weight-bearing specific manner. The final part of the session will consist of focused knee extensor strength training performed in gym machines (knee extension \& leg-press) in a combination of low-load fatiguing exercises (knee-extension) followed by high-load exercises (leg-press). Additionally, participants will receive 2 educational sessions, which include disease- and exercise specific counseling.

Other: NEMEX and education + strength training

NEMEX and education

ACTIVE COMPARATOR

Participants will undergo 12 weeks of twice weekly exercise. Each exercise session will last for approximately 60 min. and will consist of 1 hour of specific exercises to optimize sensorimotor control and achieve compensatory functional stability performed in a multiple-joint weight-bearing specific manner. Additionally, participants will receive 2 educational sessions, which include disease- and exercise specific counseling.

Other: NEMEX and education

Interventions

NEMEX and education + strength training OTHER

Optimizing sensorimotor control and achieving functional stability. Increasing knee extensor muscle strength. Teaching everyday disease management.

Also known as: GLA:D + strength training

NEMEX and education + strength training

NEMEX and education OTHER

Optimizing sensorimotor control and achieving functional stability. Teaching everyday disease management.

Also known as: GLA:D

NEMEX and education

Eligibility Criteria

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

You may qualify if:

• Patients with symptomatic and radiographically confirmed knee-OA who are found not eligible for knee replacement surgery by an orthopaedic surgeon in secondary health care.

You may not qualify if:

• Kellgren \& Lawrence score of \<2 on radiography
• Less than "mild" symptoms (mean score \>75 in 0-100 KOOS-ADL)
• Medication: Morphine for pain other than knee-joint pain
• Previous ipsilateral knee arthroplasty
• Rheumatoid arthritis
• Inability to comply with the protocol
• Inadequacy in written and spoken Danish

Sponsors & Collaborators

• Slagelse Hospital: lead
• The Danish Rheumatism Association: collaborator
• Region Zealand: collaborator
• Naestved Hospital: collaborator
• University of Southern Denmark: collaborator

Study Sites (1)

Department of planned Orthopaedic Surgery, Naestved Hospital

Næstved, Region Sjælland, 4700, Denmark

Location

Related Publications (3)

• Holm PM, Kemnitz J, Bandholm T, Wernbom M, Schroder HM, Skou ST. Muscle Function Tests as Supportive Outcome Measures for Performance-Based and Self-Reported Physical Function in Patients With Knee Osteoarthritis: Exploratory Analysis of Baseline Data From a Randomized Trial. J Strength Cond Res. 2022 Sep 1;36(9):2635-2642. doi: 10.1519/JSC.0000000000003840. Epub 2020 Oct 5.

  PMID: 33021580 DERIVED

• Holm PM, Nyberg M, Wernbom M, Schroder HM, Skou ST. Intrarater Reliability and Agreement of Recommended Performance-Based Tests and Common Muscle Function Tests in Knee Osteoarthritis. J Geriatr Phys Ther. 2021 Jul-Sep 01;44(3):144-152. doi: 10.1519/JPT.0000000000000266.

  PMID: 32304510 DERIVED

• Holm PM, Schroder HM, Wernbom M, Skou ST. Low-dose strength training in addition to neuromuscular exercise and education in patients with knee osteoarthritis in secondary care - a randomized controlled trial. Osteoarthritis Cartilage. 2020 Jun;28(6):744-754. doi: 10.1016/j.joca.2020.02.839. Epub 2020 Mar 13.

  PMID: 32179197 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis; Motor Activity

Interventions

Educational Status; Resistance Training

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Pætur M Holm, PT, MSc

  University of Southern Denmark and Department of Physiotherapy and Occupational Therapy, Naestved-Slagelse-Ringsted Hospitals.

  PRINCIPAL INVESTIGATOR

• Søren T Skou, PT, PhD

  University of Southern Denmark and Naestved-Slagelse-Ringsted Hospitals.

  STUDY CHAIR

• Henrik M Schøder, MD

  Naestved Hospital

  STUDY CHAIR

• Mathias Wernbom, PT, PhD

  Göteborg University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One blinded outcome assessor (physiotherapists) will perform measurements of muscle strength, functional capacity and pain sensitization. The MRI scans will be performed by blinded radiologists. Patients in both groups will be blinded for parallel group assignments. Statistical analysis will be performed by a blinded statistician and a blinded interpretation of the results will be performed before breaking the randomization code.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD fellow

Model Details: Parallel group, assessor- and patient blinded randomized controlled trial

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 12, 2017
• Study Start: July 18, 2017
• Primary Completion: March 8, 2019
• Study Completion: March 31, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-09

Locations

DK (1)