Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals
EKAM
Comparison of the Effects of Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals at Increased Cardiometabolic Risk
1 other identifier
interventional
100
1 country
1
Brief Summary
The main purpose of this study is to compare the effects of whole-body electromyostimulation versus a conventional low-volume strength-training program, each combined with an individualized, weight-reducing diet, on the cardiometabolic risk profile, muscle strength, body composition, inflammatory markers and subjective health outcomes in overweight individuals at increased cardiometabolic risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 10, 2017
CompletedStudy Start
First participant enrolled
November 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2020
CompletedOctober 17, 2018
October 1, 2018
2.9 years
September 27, 2017
October 15, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Metabolic Syndrome Z-Score (MetS-Z-Score)
MetS-Z-Score will be calculated from each individual's measures of waist circumference, mean arterial blood pressure, triglycerides, and HDL-cholesterol, based on equations specific to sex.
12 weeks (baseline to 12 week follow-up assessment)
Secondary Outcomes (8)
Muscle strength
12 weeks (baseline to 12 week follow-up assessment)
Body Composition
12 weeks (baseline to 12 week follow-up assessment)
Cardiorespiratory Fitness (CRF)
12 weeks (baseline to 12 week follow-up assessment)
Inflammation status
12 weeks (baseline to 12 week follow-up assessment)
Health-related quality of life
12 weeks (baseline to 12 week follow-up assessment)
- +3 more secondary outcomes
Study Arms (4)
Control
EXPERIMENTALNutritional therapy / no exercise
Standard Strength Training
EXPERIMENTALNutritional therapy combined with a Standard Strength Training program
Low-volume Strength Training
EXPERIMENTALNutritional therapy combined with a low-volume Strength Training program
Whole-body Electromyostimulation
EXPERIMENTALNutritional therapy combined with Whole-Body Electromyostimulation
Interventions
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with a standard strength training program: * 5 strength training exercises (chest, upper/lower back, abdominals, legs) * 3 sets per exercise * time-effort per session: \~90 min * 2 training sessions per week * duration of exercise intervention: 12 weeks
Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined a low-volume strength training program: * 5 strength training exercises (chest, upper/lower back, abdominals, legs) * 1 set per exercise * time-effort per session: \~20 min * 2 training sessions per week * duration of exercise intervention: 12 weeks
Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with WB-EMS: * time-effort per session: \~20 min * duration of exercise intervention: 12 weeks
Eligibility Criteria
You may qualify if:
- Body Mass Index \>25
- presence of at least 2 cardiometabolic risk factors
You may not qualify if:
- Healthy persons or patients under age
- Overweight persons without any additional cardiometabolic risk factors
- Pregnancy, Lactation
- Psychological disorders, epilepsy, sever neurological disorders
- Participation in other exercise- or nutrition studies within the last 6 months
- acute cardiovascular disease
- malignant disease
- Rheuma
- Intake of anabolic drugs,
- Skin injuries in the area of electrode placements
- Electronic implants (defibrillator, pacemaker)
- Persons in mental hospitals by order of authorities or jurisdiction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,
Erlangen, 91052, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dejan Reljic, Dr.
University Erlangen Nuremberg Medical School
- PRINCIPAL INVESTIGATOR
Yurdaguel Zopf, Prof.
University Erlangen Nuremberg Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2017
First Posted
October 10, 2017
Study Start
November 1, 2017
Primary Completion
September 30, 2020
Study Completion
September 30, 2020
Last Updated
October 17, 2018
Record last verified: 2018-10