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

Primary Purpose

Overweight and Obesity, Metabolic Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
HIIT + WB-EMS
WB-EMS + HIIT
HIIT + CST
CST + HIIT
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Cardiometabolic Health, Cardiorespiratory Fitness, Muscular Strength, Body Composition, Inflammation, Aerobic Exercise, Resistance Exercise

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
  • 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, Friedrich-Alexander-University Erlangen-NurembergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

HIIT + WB-EMS

WB-EMS + HIIT

HIIT + CST

CST + HIIT

Arm Description

High-intensity interval training (HIIT) combined with whole-body electromyostimulation (WB-EMS) Sequence of application: HIIT - WB-EMS

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

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

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

Outcomes

Primary Outcome Measures

Change in 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.
Change in overall Physical Fitness Score (PFS)
PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.

Secondary Outcome Measures

Change in Body Composition
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Change in HOMA-IR
Insulin resistance will be estimated using homeostasis model assessment index (HOMA)
Change Inflammation status
Inflammation will be assessed by measuring levels of inflammatory blood markers (CRP, inflammatory cytokines)
Change in Health-related quality of life
Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
Change in Pain scores
Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
Change in Perceived stress
Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
Change Subjective work ability
Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)

Full Information

First Posted
July 1, 2018
Last Updated
October 15, 2018
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03710447
Brief Title
Effects of Concurrent HIIT and WB-EMS Exercise on the Cardiometabolic Risk Profile in Obese Individuals
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2018 (Anticipated)
Primary Completion Date
October 30, 2021 (Anticipated)
Study Completion Date
October 30, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

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
Cardiometabolic Health, Cardiorespiratory Fitness, Muscular Strength, Body Composition, Inflammation, Aerobic Exercise, Resistance Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment 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
HIIT + WB-EMS
Arm Type
Experimental
Arm Description
High-intensity interval training (HIIT) combined with whole-body electromyostimulation (WB-EMS) Sequence of application: HIIT - WB-EMS
Arm Title
WB-EMS + HIIT
Arm Type
Experimental
Arm Description
Whole-body electromyostimulation (WB-EMS) combined with High-intensity interval training (HIIT) Sequence of application: WB-EMS - HIIT
Arm Title
HIIT + CST
Arm Type
Experimental
Arm Description
High-intensity interval training (HIIT) combined with conventional low-volume strength training (CST) Sequence of application: HIIT - CST
Arm Title
CST + HIIT
Arm Type
Experimental
Arm Description
Conventional low-volume strength training (CST) combined with high-intensity interval training (HIIT) Sequence of application: CST - HIIT
Intervention Type
Other
Intervention Name(s)
HIIT + WB-EMS
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
WB-EMS + HIIT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
HIIT + CST
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
CST + HIIT
Intervention Description
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 Measure Information:
Title
Change in 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
12 weeks
Title
Change in overall Physical Fitness Score (PFS)
Description
PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in Body Composition
Description
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Time Frame
12 weeks
Title
Change in HOMA-IR
Description
Insulin resistance will be estimated using homeostasis model assessment index (HOMA)
Time Frame
12 week
Title
Change Inflammation status
Description
Inflammation will be assessed by measuring levels of inflammatory blood markers (CRP, inflammatory cytokines)
Time Frame
12 weeks
Title
Change in Health-related quality of life
Description
Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
Time Frame
12 weeks
Title
Change in Pain scores
Description
Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
Time Frame
12 weeks
Title
Change in Perceived stress
Description
Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
Time Frame
12 weeks
Title
Change Subjective work ability
Description
Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dejan Reljic, Dr.
Phone
+49 9131 8545218
Email
dejan.reljic@uk-erlangen.de
First Name & Middle Initial & Last Name or Official Title & Degree
Yurdaguel Zopf, Prof.
Phone
+49 9131 8545218
Email
yurdaguel.zopf@uk-erlangen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan Reljic, Dr.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dejan Reljic, Dr.
Phone
+49 9131 8545218
Email
dejan.reljic@uk-erlangen.de
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof.
Phone
+49 9131 8545218
Email
yurdaguel.zopf@uk-erlangen.de

12. IPD Sharing Statement

Learn more about this trial

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

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