CClinicalTrials.gg
Status unknownNCT03306056EKAMUpdated Oct 17, 2018

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

An interventional study of Control and Standard Strength Training in Overweight and Obesity and Metabolic Syndrome, sponsored by University of Erlangen-Nürnberg Medical School. Status unknown at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.

Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight and Obesity
  • Metabolic Syndrome

Keywords

  • Exercise
  • Strength Training
  • Health Promotion
  • Inflammation
  • Body Composition
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Body Mass Index >25
  • presence of at least 2 cardiometabolic risk factors

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Control

    Nutritional therapy / no exercise

    Other: Control

  • Experimental
    Standard Strength Training

    Nutritional therapy combined with a Standard Strength Training program

    Other: Standard Strength Training

  • Experimental
    Low-volume Strength Training

    Nutritional therapy combined with a low-volume Strength Training program

    Other: Low-volume Strength Training

  • Experimental
    Whole-body Electromyostimulation

    Nutritional therapy combined with Whole-Body Electromyostimulation

    Other: Whole-Body Electromyostimulation (WB-EMS)

Interventions

  • OtherControl

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

  • OtherStandard 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

  • OtherLow-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

  • OtherWhole-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

05

What researchers measure

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.

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

Secondary outcomes

  1. 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)

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

  2. Body Composition

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

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

  3. Cardiorespiratory Fitness (CRF)

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

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

  4. Inflammation status

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

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

  5. Health-related quality of life

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

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

  6. Pain scores

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

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

  7. Perceived stress

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

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

  8. Subjective work ability

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

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

06

Study locations

1 of 1 sites recruiting
07

Registry details

Key details

Study ID
NCT03306056
Lead sponsor
University of Erlangen-Nürnberg Medical School
Responsible party
Sponsor
First posted
Oct 10, 2017
Start date
Nov 1, 2017
Primary completion
Sep 30, 2020 (estimated)
Completion
Sep 30, 2020 (estimated)
Last update
Oct 17, 2018

Study contacts

Dejan Reljic, Dr.
Contact
dejan.reljic@uk-erlangen.de
+49 9131 8545218
Yurdaguel Zopf, Prof.
Contact
yurdaguel.zopf@uk-erlangen.de
+49 9131 8545218
Dejan Reljic, Dr.
principal investigator · University Erlangen Nuremberg Medical School
Yurdaguel Zopf, Prof.
principal investigator · University Erlangen Nuremberg Medical School

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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