Whole-body Electromyostimulation in Inpatient Rehabilitation

NCT03767088 | Completed

• 1 other identifier: UWittenHerdecke
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

Based on various studies, scientific evidence has proven the effectiveness of whole-body electromyostimulation (WB-EMS) on parameters such as increased physiological performance and body composition. As a pilot project, the aim of the study is to determine the effect of additional WB-EMS as part of the inpatient four-week rehabilitation of sarcopenic subjects.

Conditions

Sarcopenia

Keywords

WB-EMS; rehabilitation; sarcopenia

Outcome Measures

Primary Outcomes (3)

• (isometric) muscle strength of arms, legs and trunk (extenstion)

  isometric strength \[Nm\] (DIERs Myoline professional, DIERs International GmbH)

  4 weeks

• muscle function

  chair rise test \[repetitions; n\]

  4 weeks

• muscle function / submaximal performance test

  6 minute walking test \[distance; m\]

  4 weeks

Secondary Outcomes (16)

• muscle mass via multifrequency bioimpedance analysis

  4 weeks

• body fat via multifrequency bioimpedance analysis

  4 weeks

• blood-sample: triglycerides

  4 weeks

• blood-sample: high-density lipoprotein (HDL)

  4 weeks

• blood-sample: low-density lipoprotein (LDL)

  4 weeks

Study Arms (3)

WB-EMS

ACTIVE COMPARATOR

1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 8 muscle groups (legs, gluteal region, core, arms) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration

Device: WB-EMS

partial WB-EMS

ACTIVE COMPARATOR

1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session stimulation of 2 muscle groups (legs, gluteal region; lower extremities) while performing slight eccentric pronounced physiological movement patterns parameters: 85 Hz, 350ms, intermittent, 4 s load vs 4 s regeneration

Device: WB-EMS

control

SHAM COMPARATOR

active sham comparator: 1.5 sessions per week; in total: 6 training sessions training duration: 20 min per session performing slight eccentric pronounced physiological movement patterns

Other: (synchronized) Training program without WB-EMS

Interventions

WB-EMS DEVICE

whole body electromyostimulation

WB-EMS; partial WB-EMS

(synchronized) Training program without WB-EMS OTHER

20 min of pronounced eccentric movement patterns

control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• skeletal muscle index (SMI) \< 0,789 (men); \< 0,512 (women)
• A general state of good health
• Medically approved unrestricted sports participation as shown by diagnostic performance test
• Willingness to provide signed informed consent

You may not qualify if:

• Post-coronary artery bypass graft (ACVB) surgery in the last 3 months
• Condition after pacemaker and defibrillator implantation
• renal insufficiency from stage 3a
• epilepsy
• feverish diseases or infectious diseases
• Taking medicines the affect muscle metabolism
• severe neurological disorders
• Skin injuries in the area of electrodes

Sponsors & Collaborators

• Prof. Dr. Frank Mooren: lead

Study Sites (1)

Klinik Königsfeld der DRV

Ennepetal, North Rhine-Westphalia, 58256, Germany

Location

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Frank C Mooren, Prof

  Department of Rehabilitation Science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. (Lehrstuhl für Rehabilitationswissenschaften)

Model Details: prospective randomized controlled parallel group design

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 6, 2018
• Study Start: January 1, 2019
• Primary Completion: March 15, 2020
• Study Completion: March 15, 2020
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

DE (1)