EXercise as TReatment for osteoArthritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-18

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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Osteoarthritis (OA) is one of the most prevalent musculoskeletal diseases worldwide. In Denmark, it is estimated that approximately 900.000 people, or 1 out of 5 residents are suffering from OA in one or more joints. The annual socio-economic costs (treatment and loss of labour) as a direct consequence of OA in Denmark are estimated to 11.5 billion "Danish kroner" (DKK).

Osteoarthritis of the knee is the most frequently reported and disabling OA subgroup and is mainly reported in middle-aged adults (≥40 years) with an increasing prevalence with increasing age. Knee osteoarthritis is associated with knee pain, loss of lower limb muscle strength, activity limitations and reduced quality of life. Moreover, pain sensitization, i.e. increased responsiveness of nociceptive neurons, is another mechanism involved in pain and disability in knee-OA and may contribute to the frequently reported disparities between pain symptoms and radiographic signs of structural damage.

The current non-surgical treatment recommendations in Denmark as well as internationally include offering one or more of: Patient education, dietary advice, weight loss counselling and exercise. Exercise has proven to be a potent stimulus to improve function, and general quality of life in people with knee-OA. Moreover, exercise has been shown to reduce pain sensitization in knee-OA subjects with clinical signs of sensitization. However, there is still a paucity of information on the exact exercise mode for greatest beneficial effects in the knee-OA population.

Reduced lower limb muscle strength has repeatedly been suggested as one of the main working mechanisms behind knee-OA symptoms and quadriceps muscle strength is even suggested as a potential mediating factor in future knee joint space narrowing and longitudinal worsening of knee-joint pain. A recent systematic review revealed upper leg muscle strength along with joint proprioception to be two of the most potent mediating factors in symptomatic knee-OA.

In a randomized controlled trial (RCT) design, this study seeks to investigate potential added benefits of supplementing NEMEX and education with focused knee extensor strength training in patients with knee-OA. 90 patients deemed ineligible for knee replacement surgery will be recruited from the ambulatory setting at Naestved Hospital. By random allocation, patients will be recruited to either 12 weeks (twice weekly) of NEMEX and education + focused knee extensor strength training (intervention group) or 12 weeks (twice weekly) of NEMEX and education only (control group).

The main outcome is the change in KOOS-ADL from baseline to 12-week follow-up. Other outcomes include the remaining KOOS subscales, self-reported pain, health status, physical activity and patient satisfaction, knee extensor muscle power and knee extensor maximal contractile strength, pain sensitization, MRI assessed thigh muscle quality and physical function.

Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group, assessor- and patient blinded randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Study Groups

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NEMEX and education + strength training

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.

Group Type EXPERIMENTAL

NEMEX and education + strength training

Intervention Type OTHER

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

NEMEX and education

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.

Group Type ACTIVE_COMPARATOR

NEMEX and education

Intervention Type OTHER

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

Interventions

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NEMEX and education + strength training

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

Intervention Type OTHER

NEMEX and education

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

Intervention Type OTHER

Other Intervention Names

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GLA:D + strength training GLA:D

Eligibility Criteria

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Inclusion Criteria

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.

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No