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

NCT ID: NCT03306056

Last Updated: 2018-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-01

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Overweight and Obesity Metabolic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

parallel-group, randomized-controlled study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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Control

Nutritional therapy / no exercise

Group Type EXPERIMENTAL

Control

Intervention Type OTHER

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

Standard Strength Training

Nutritional therapy combined with a Standard Strength Training program

Group Type EXPERIMENTAL

Standard Strength Training

Intervention Type OTHER

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

Nutritional therapy combined with a low-volume Strength Training program

Group Type EXPERIMENTAL

Low-volume Strength Training

Intervention Type OTHER

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

Nutritional therapy combined with Whole-Body Electromyostimulation

Group Type EXPERIMENTAL

Whole-Body Electromyostimulation (WB-EMS)

Intervention Type OTHER

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

Interventions

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Control

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dejan Reljic, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Yurdaguel Zopf, Prof.

Role: PRINCIPAL_INVESTIGATOR

University Erlangen Nuremberg Medical School

Locations

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

Erlangen, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Dejan Reljic, Dr.

Role: CONTACT

+49 9131 8545218

Yurdaguel Zopf, Prof.

Role: CONTACT

+49 9131 8545218

Facility Contacts

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Dejan Reljic, Dr.

Role: primary

+49 9131 8545218

Yurdaguel Zopf, Prof.

Role: backup

+49 9131 8545218

Other Identifiers

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EKAM-Study

Identifier Type: -

Identifier Source: org_study_id

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