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Trial record 23 of 32 for:    Recruiting, Not yet recruiting, Available Studies | obesity | stimulation

Effects of Concurrent HIIT and WB-EMS Exercise on the Cardiometabolic Risk Profile in Obese Individuals

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ClinicalTrials.gov Identifier: NCT03710447
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
The main purpose of this study is to compare the impact of concurrent high-intensity interval training (HIIT) and whole-body electromyostimulation exercise (WB-EMS) or low-volume conventional strength training (CST) on the cardiometabolic risk profile, overall physical fitness (cardiorespiratory fitness and muscular strength), body composition, inflammatory markers and subjective health outcomes after a 12-week intervention trial in overweight individuals at increased cardiometabolic risk. Furthermore, this study aims to investigate the influence of intra-session exercise order on all outcomes.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Metabolic Syndrome Other: HIIT + WB-EMS Other: WB-EMS + HIIT Other: HIIT + CST Other: CST + HIIT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment parallel-group, randomized-controlled study
Masking: Single (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).
Primary Purpose: Treatment
Official Title: Effects of Concurrent High-Intensity Interval Training and Whole-Body Electromyostimulation on the Cardiometabolic Risk Profile in Obese Individuals at Increased Risk for the Metabolic Syndrome
Estimated Study Start Date : October 15, 2018
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HIIT + WB-EMS
High-intensity interval training (HIIT) combined with whole-body electromyostimulation (WB-EMS) Sequence of application: HIIT - WB-EMS
Other: HIIT + WB-EMS

12-week supervised exercise program consisting of ergometer-based high-intensity interval training (HIIT) and whole-body electromyostimulation (WB-EMS).

HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. WB-EMS: Simulanteous stimulation of all major muscle groups with dedicated individual intensity.

2 exercise sessions per week. Order of application: HIIT - WB-EMS. Additionally, participants receive individualized nutritional counseling.


Experimental: WB-EMS + HIIT
Whole-body electromyostimulation (WB-EMS) combined with High-intensity interval training (HIIT) Sequence of application: WB-EMS - HIIT
Other: WB-EMS + HIIT

12-week supervised exercise program consisting of whole-body electromyostimulation (WB-EMS) and ergometer-based high-intensity interval training (HIIT).

WB-EMS: Simulanteous stimulation of all major muscle groups with dedicated individual intensity.

HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. 2 exercise sessions per week. Order of application: WB-EMS - HIIT. Additionally, participants receive individualized nutritional counseling.


Experimental: HIIT + CST
High-intensity interval training (HIIT) combined with conventional low-volume strength training (CST) Sequence of application: HIIT - CST
Other: HIIT + CST

12-week supervised exercise program consisting of ergometer-based high-intensity interval training (HIIT) and conventional low-volume strength training(CST).

HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. CST: Conventional 1-set strength training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum.

2 exercise sessions per week. Order of application: HIIT - CST. Additionally, participants receive individualized nutritional counseling.


Experimental: CST + HIIT
Conventional low-volume strength training (CST) combined with high-intensity interval training (HIIT) Sequence of application: CST - HIIT
Other: CST + HIIT

12-week supervised exercise program consisting of conventional low-volume strength training(CST) and ergometer-based high-intensity interval training (HIIT).

CST: Conventional 1-set strength training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum.

HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. 2 exercise sessions per week. Order of application: CST - HIIT. Additionally, participants receive individualized nutritional counseling.





Primary Outcome Measures :
  1. Change in Metabolic Syndrome Z-Score (MetS-Z-Score). [ Time Frame: 12 weeks ]
    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.

  2. Change in overall Physical Fitness Score (PFS) [ Time Frame: 12 weeks ]
    PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.


Secondary Outcome Measures :
  1. Change in Body Composition [ Time Frame: 12 weeks ]
    Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)

  2. Change in HOMA-IR [ Time Frame: 12 week ]
    Insulin resistance will be estimated using homeostasis model assessment index (HOMA)

  3. Change Inflammation status [ Time Frame: 12 weeks ]
    Inflammation will be assessed by measuring levels of inflammatory blood markers (CRP, inflammatory cytokines)

  4. Change in Health-related quality of life [ Time Frame: 12 weeks ]
    Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire

  5. Change in Pain scores [ Time Frame: 12 weeks ]
    Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)

  6. Change in Perceived stress [ Time Frame: 12 weeks ]
    Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)

  7. Change Subjective work ability [ Time Frame: 12 weeks ]
    Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • Electronic implants (defibrillator, pacemaker)
  • Persons in mental hospitals by order of authorities or jurisdiction

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03710447


Contacts
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Contact: Dejan Reljic, Dr. +49 9131 8545218 dejan.reljic@uk-erlangen.de
Contact: Yurdaguel Zopf, Prof. +49 9131 8545218 yurdaguel.zopf@uk-erlangen.de

Locations
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Germany
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg Recruiting
Erlangen, Germany, 91052
Contact: Dejan Reljic, Dr.    +49 9131 8545218    dejan.reljic@uk-erlangen.de   
Contact: Yurdaguel Zopf, Prof.    +49 9131 8545218    yurdaguel.zopf@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Dejan Reljic, Dr. University Erlangen Nuremberg Medical School
Principal Investigator: Yurdaguel Zopf, Prof. University Erlangen Nuremberg Medical School

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03710447     History of Changes
Other Study ID Numbers: COMBI-Study
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Cardiometabolic Health
Cardiorespiratory Fitness
Muscular Strength
Body Composition
Inflammation
Aerobic Exercise
Resistance Exercise
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Overweight
Disease
Pathologic Processes
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases