Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial)

NCT03796832 | Completed

• 3 other identifiers: B670201835057G013318NU1111-1225-9954
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) is a chronic degenerative joint disease and leading cause of musculoskeletal pain and disability worldwide. The high rates of knee replacement surgery worldwide emphasize the need for more effective non-surgical interventions to attenuate progressive disability. International scientific and professional societies also propose that therapies need to seek efficacious combinations of modalities with the ultimate aim to achieve longer-term, optimal and synergistic treatment effects. Exercise therapy, such as strengthening and aerobic exercise, is universally, and strongly, recommended as it demonstrates beneficial effects on clinical symptoms and is considered safe for all patients with knee OA. However, during activities as simple as walking, higher knee joint loads have been demonstrated in people with medial tibiofemoral OA, a common form of knee OA. Increased joint loading as such may elicit aggravated symptoms and accelerated joint structural decline over time. No convincing evidence exists to confirm exercise therapy effectively alters joint loading parameters during walking gait in people with knee OA. Notably, recent studies suggest that wearing appropriate footwear may help offload the joint in people with knee OA, a strategy that is also easily applicable at a wide population level. The purpose of this clinical study is to compare 9-month treatment consisting of exercise therapy and daily wear of one of two shoe classes (flat flexible shoes or stable supportive shoes), on symptom relief and joint structural damage in people with knee OA. In this study, we will randomly allocate eligible participants in one of two treatment arms. This means there will be an equal amount of participants in each group, and participants nor researchers will be able to choose in which group participants will end up in.Participants in both groups will enroll in a 9 month exercise program and will be provided a pair of one of the two shoe classes to wear daily. To ensure an unbiased appraisal of treatment effects, we will not disclose the study hypotheses to participants during the intervention period. The results of this study will help determine whether the addition of appropriate footwear to exercise therapy improves symptom relief and/or slows structural disease progression in people with knee OA.

Conditions

Knee Osteoarthritis

Keywords

Knee Osteoarthritis; Exercise Therapy; Shoes; Pain

Outcome Measures

Primary Outcomes (1)

• Change in severity of knee pain on walking

  Scored on an 11-point numeric rating scale for average knee pain on walking over the past week, with terminal descriptors of "0=no pain" to "10=worst pain imaginable".

  Measured at baseline, 13 and 37 weeks

Secondary Outcomes (11)

• Severity of intercondylar synovitis

  Measured at baseline, 13 and 37 weeks

• Severity of whole knee effusion

  Measured at baseline, 13 and 37 weeks

• Severity of bone marrow lesions

  Measured at baseline, 13 and 37 weeks

• Severity of physical dysfunction

  Measured at baseline, 13 and 37 weeks

• Severity of knee pain overall

  Measured at baseline, 13 and 37 weeks

Other Outcomes (18)

• Adherence to shoe usage

  Measured by pedometer at week 1, week 12, week 37, and by logbooks at month 1 , month 2, month 3, month 4, month 5, month 6, month 7, month 8, month 9

• Adherence to exercise therapy

  Measured at week 1, week 2, week 3, week 4, week 5, week 6, week 7, week 8, week 9, week 10, week 11, week 12 and month 4, month 5, month 6, month 7, month 8, month 9

• Adverse events, co-interventions including medication use

  Measured at baseline, 13 and 37 weeks

Study Arms (2)

Flat Flexible Shoes+Exercise Therapy

EXPERIMENTAL

This arm will wear Flat Flexible Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9).

Device: Flat Flexible Shoes; Other: Exercise Therapy

Stable Supportive Shoes+Exercise Therapy

ACTIVE COMPARATOR

This arm will wear Stable Supportive Shoes daily for the duration of 9 months combined with supervised facility-based and home-based exercise therapy (months 0-3) and unsupervised home-based exercise therapy (months 4-9).

Device: Stable Supportive Shoes; Other: Exercise Therapy

Interventions

Flat Flexible Shoes DEVICE

Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height \<15 mm, (ii) shoe pitch \<10 mm, (iii) absent arch support/motion control, (iv) minimal sole rigidity, (v) weight \<=200g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible.

Flat Flexible Shoes+Exercise Therapy

Stable Supportive Shoes DEVICE

Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height \>30 mm, (ii) shoe pitch \>10 mm, (iii) present arch support/motion control, (iv) sole rigidity, (v) weight \>300g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible.

Stable Supportive Shoes+Exercise Therapy

Exercise Therapy OTHER

The 3-month supervised exercise program will consist of one group session per week of approximately 30 minutes complemented with home-based exercises 3 times per week. Group sessions will consist of a 10-min warm-up followed by a circuit training of strengthening and/or neuromuscular exercises. Subsequently, during a 6-month unsupervised home exercise program, participants will perform strengthening exercises of the lower limb muscles 3 times weekly. Throughout the 9-month intervention, participants will be encouraged to maintain a daily routine of aerobic exercises, consisting of structured activity bouts of at least 10 minutes at a moderate intensity (grade 5-6 (out of 10, maximum exertion) on a Rate of Perceived Exertion scale), achieving at least 70 minutes of weekly physical activity at 3 months and 150 minutes at 9 months.

Flat Flexible Shoes+Exercise Therapy; Stable Supportive Shoes+Exercise Therapy

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic and radiographic diagnosis of knee OA as per the American College of Rheumatology criteria (ie, aged≥50, knee pain on most days and osteophytes)
• Radiographic evidence of medial OA (ie, Kellgren Lawrence(KL) grade ≥2, ≥grade 1 medial joint space narrowing (JSN) (scale 0-3)\> lateral JSN, using a standardized atlas)
• Average knee pain on walking over the past week of ≥4 on a 11-point numeric rating scale (NRS; "0=no pain" to "10=worst pain imaginable")
• Ability to walk unaided
• Willing to comply with therapy prescriptions
• Sufficient understanding of the Dutch language

You may not qualify if:

• Current and previous (3 months) participation in exercise therapy
• Current and previous (3 months) use of customised footwear, minimalist shoes, insoles, braces and unable/unwilling to abandon during the study
• Knee surgery in either knee and/or injections (corticosteroids, hyaluronic acid) in the study knee (most painful knee or right knee if both equally painful) in the past 6 months
• Current or recent (4 weeks) use of oral corticosteroids
• Knee replacement or high tibial osteotomy surgery in the past, or planned during the study
• Inflammatory arthropathies
• Other muscular, joint, neurological or metabolic conditions affecting lower limb function and/or precluding safe regular participation in exercise therapy and walking
• Body mass index (BMI) of \>36 kg/m2 (due to difficulties performing gait analysis and MRI)
• Foot/ankle pain/pathologies at either side, and worse than knee pain complaints
• Contra-indications for radiography \& MRI
• Use of supplements (eg, glucosamine, chondroitin, curcuma derivates) or pain medication (NSAIDs, paracetamol) or other disease modifying or anti-bone resorptive drugs if participants were not on a stable dose for ≥2 months prior to entering the trial

Sponsors & Collaborators

• University Ghent: lead
• Universiteit Antwerpen: collaborator

Study Sites (1)

Ghent University, Department of Rehabilitation Sciences

Ghent, 9000, Belgium

Location

Related Publications (1)

• Dainese P, Stautemas J, De Mits S, Wittoek R, Van Ginckel A, Huysse W, Demeyer H, Mahieu H, Calders P. Exercise and footwear in medial knee osteoarthritis: a randomized controlled trial comparing flat flexible footwear to stable supportive shoes. Rheumatol Adv Pract. 2024 Oct 30;8(4):rkae133. doi: 10.1093/rap/rkae133. eCollection 2024.

  PMID: 39669115 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Patrick Calders, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a mono-centre randomized controlled trial with a 1:1 allocation into the experimental treatment (exercise therapy and Flat Flexible Shoes) and comparator treatment (exercise therapy and Stable Supportive Shoes). Exercise therapy will consist of supervised facility- and home-based exercises for 3 months (primary time point) and unsupervised home-based exercises for a subsequent 6 months (secondary time point).

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: January 8, 2019
• Study Start: January 28, 2019
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)