Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals

Metabolic Syndrome Clinical Trial

— EKAM  

Official title:

Comparison of the Effects of Whole-body Electromyostimulation Versus Conventional Low-volume Strength Training in Overweight Individuals at Increased Cardiometabolic Risk

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03306056
• Other study ID #: EKAM-Study
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2018
• Source: University of Erlangen-Nürnberg Medical School
• Contact: Dejan Reljic, Dr.
• Phone: +49 9131 8545218
• Email: dejan.reljic[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index >25

• presence of at least 2 cardiometabolic risk factors

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Overweight
• Overweight and Obesity

Intervention

Other:
• Control
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
• Standard Strength Training
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
• Low-volume Strength Training
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
• Whole-Body Electromyostimulation (WB-EMS)
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

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Muscle strength	Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices (Butterfly, Pull-down, Hyperextension, Abdominal Crunch, Leg-Press)	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Body Composition	Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Cardiorespiratory Fitness (CRF)	CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Inflammation status	Inflammation will be assessed by measuring Levels of CRP and inflammatory cytokines and other inflammatory blood markers	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Health-related quality of life	Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Pain scores	Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Perceived stress	Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Subjective work ability	Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)	12 weeks (baseline to 12 week follow-up assessment)