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

Primary Purpose

Overweight and Obesity, Metabolic Syndrome

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Control

Standard Strength Training

Low-volume Strength Training

Whole-Body Electromyostimulation (WB-EMS)

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Exercise, Strength Training, Health Promotion, Inflammation, Body Composition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Control

Standard Strength Training

Low-volume Strength Training

Whole-body Electromyostimulation

Arm Description

Nutritional therapy / no exercise

Nutritional therapy combined with a Standard Strength Training program

Nutritional therapy combined with a low-volume Strength Training program

Nutritional therapy combined with Whole-Body Electromyostimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Body Composition

Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)

Cardiorespiratory Fitness (CRF)

CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)

Inflammation status

Inflammation will be assessed by measuring Levels of CRP and inflammatory cytokines and other inflammatory blood markers

Health-related quality of life

Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire

Pain scores

Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)

Perceived stress

Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)

Subjective work ability

Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)

Full Information

NCT ID

NCT03306056

First Posted

September 27, 2017

Last Updated

October 15, 2018

Sponsor

University of Erlangen-Nürnberg Medical School

1. Study Identification

Unique Protocol Identification Number

NCT03306056

Brief Title

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

Acronym

EKAM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2018

Overall Recruitment Status

Unknown status

Study Start Date

November 1, 2017 (Actual)

Primary Completion Date

September 30, 2020 (Anticipated)

Study Completion Date

September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overweight and Obesity, Metabolic Syndrome

Keywords

Exercise, Strength Training, Health Promotion, Inflammation, Body Composition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

parallel-group, randomized-controlled study

Masking

Outcomes Assessor

Masking Description

Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Control

Arm Type

Experimental

Arm Description

Nutritional therapy / no exercise

Arm Title

Standard Strength Training

Arm Type

Experimental

Arm Description

Nutritional therapy combined with a Standard Strength Training program

Arm Title

Low-volume Strength Training

Arm Type

Experimental

Arm Description

Nutritional therapy combined with a low-volume Strength Training program

Arm Title

Whole-body Electromyostimulation

Arm Type

Experimental

Arm Description

Nutritional therapy combined with Whole-Body Electromyostimulation

Intervention Type

Other

Intervention Name(s)

Control

Intervention Description

Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks

Intervention Type

Other

Intervention Name(s)

Standard Strength Training

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Low-volume Strength Training

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Whole-Body Electromyostimulation (WB-EMS)

Intervention Description

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

Primary Outcome Measure Information:

Title

Metabolic Syndrome Z-Score (MetS-Z-Score)

Description

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.

Time Frame