EMSOAT
Whole-body Electromyostimulation for the Treatment of Knee Osteoarthritis (EMSOAT) in Overweight People - a Randomized Controlled Trial
Sponsor study identifier
interventional
72
1 country
1
Study Start
June 1, 2022
Actual (reported)Primary Completion
October 31, 2023
Actual (reported)Study Completion
April 1, 2024
Actual (reported)The aim of the present study is to evaluate the effects of WB-EMS application in overweight women and men with knee osteoarthritis, with special consideration of sustainability. In this randomised controlled trial 72 overweight patients with knee osteoarthritis aged 40-70 years will be included and randomly assigned to two groups (WB-EMS vs. control group (CG)). The intervention group will perform six WB-EMS sessions/month of 20 min for 6 months. An intermittent low frequency WB-EMS-protocol with an impulse phase of 6s, followed by an impulse break of 4s will be applied. The control group will undergo a tailored physiotherapy program of 6 sessions defined as usual care. In addition, both groups will complete a self-management training programme for osteoarthritis of 6 sessions over 12 weeks.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 1, 2024
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 1, 2022
Actual (reported)January 2, 2023
Actual (reported)January 5, 2023
Actual (reported)October 31, 2023
Actual (reported)April 1, 2024
Actual (reported)Knee pain
Changes in pain of the knee joint as determined by the Knee Injury and Osteoarthritis Outcome Score (KOOS) in the WB-EMS- compared to changes in the control group.KOOS score for "knee pain" vary from 1 (never/no pain) to 5 (always/very severe pain)
baseline to 6 month follow up
Self rated symptoms
baseline to 6-month follow-up
Knee stiffness
baseline to 6-month follow-up
Function in daily living
baseline to 6-month follow-up
Function in sports and recreational activities
baseline to 6-month follow-up
Quality of Life
baseline to 6-month follow-up
Drop-out rate
baseline to 6-month follow-up
Attendance rate
baseline to 6-month follow-up
WB-EMS application
Standardised physiotherapy (six sessions)
Consistently supervised, video-guided WB-EMS application 1.5 times per week for 28 weeks. Bipolar electric current with a frequency of 85Hz, an impulse-width of 350 µs will be used in an interval approach with 6 sec of EMS stimulation with a direct impulse boost and 4 sec of rest. Low intensity movements or exercises in a standing position were performed during the 6 s stimulation period.
Six standardised physiotherapy sessions (20 min each)
Institute of Medical Physics University of Erlangen-Nurnberg
Erlangen, 91052, Germany
Kemmler W, Kleinoder H, Frohlich M. Editorial: Whole-body electromyostimulation: A training technology to improve health and performance in humans? volume II. Front Physiol. 2022 Aug 5;13:972011. doi: 10.3389/fphys.2022.972011. eCollection 2022. No abstract available.
Bloeckl J, Raps S, Weineck M, Kob R, Bertsch T, Kemmler W, Schoene D. Feasibility and Safety of Whole-Body Electromyostimulation in Frail Older People-A Pilot Trial. Front Physiol. 2022 Jun 24;13:856681. doi: 10.3389/fphys.2022.856681. eCollection 2022.
Stephanie Kast, MSc
Institute of Radiology, University Hospital-Nürnberg
72 participants (actual enrollment reported by the registry).
First Submitted
January 2, 2023
First Posted
January 5, 2023
Study Start
June 1, 2022
Actual (reported)Evaluate Efficacy and Safety of X0002 in Treatment of Knee Osteoarthritis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Kemmler W, Shojaa M, Steele J, Berger J, Frohlich M, Schoene D, von Stengel S, Kleinoder H, Kohl M. Efficacy of Whole-Body Electromyostimulation (WB-EMS) on Body Composition and Muscle Strength in Non-athletic Adults. A Systematic Review and Meta-Analysis. Front Physiol. 2021 Feb 26;12:640657. doi: 10.3389/fphys.2021.640657. eCollection 2021.
Primary Completion
October 31, 2023
Actual (reported)Study Completion
April 1, 2024
Actual (reported)Last Updated
May 8, 2024
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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