Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial)

NACompletedINTERVENTIONAL
Enrollment

97

Participants

Timeline

Start Date

January 28, 2019

Primary Completion Date

June 1, 2022

Study Completion Date

June 1, 2022

Conditions
Knee Osteoarthritis
Interventions
DEVICE

Flat Flexible Shoes

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.

DEVICE

Stable Supportive Shoes

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.

OTHER

Exercise Therapy

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.

Trial Locations (1)

9000

Ghent University, Department of Rehabilitation Sciences, Ghent

All Listed Sponsors
collaborator

Universiteit Antwerpen

OTHER

lead

University Ghent

OTHER

NCT03796832 - Footwear and Exercise for Knee Osteoarthritis (FiREwORK Trial) | Biotech Hunter | Biotech Hunter