NCT03710447

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

October 15, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 18, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2021

Completed
Last Updated

October 18, 2018

Status Verified

October 1, 2018

Enrollment Period

3 years

First QC Date

July 1, 2018

Last Update Submit

October 15, 2018

Conditions

Keywords

Cardiometabolic HealthCardiorespiratory FitnessMuscular StrengthBody CompositionInflammationAerobic ExerciseResistance Exercise

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks

  • Change in overall Physical Fitness Score (PFS)

    PFS is calculated from VO2max and 1 Repmax values of 5 major muscle Groups.

    12 weeks

Secondary Outcomes (7)

  • Change in Body Composition

    12 weeks

  • Change in HOMA-IR

    12 week

  • Change Inflammation status

    12 weeks

  • Change in Health-related quality of life

    12 weeks

  • Change in Pain scores

    12 weeks

  • +2 more secondary outcomes

Study Arms (4)

HIIT + WB-EMS

EXPERIMENTAL

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

Other: HIIT + WB-EMS

WB-EMS + HIIT

EXPERIMENTAL

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

Other: WB-EMS + HIIT

HIIT + CST

EXPERIMENTAL

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

Other: HIIT + CST

CST + HIIT

EXPERIMENTAL

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

Other: CST + HIIT

Interventions

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.

HIIT + WB-EMS

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.

WB-EMS + HIIT

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.

HIIT + CST

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.

CST + HIIT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg

Erlangen, 91052, Germany

RECRUITING

MeSH Terms

Conditions

OverweightObesityMetabolic SyndromeInflammation

Interventions

galactosylceramide sulfotransferase

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesPathologic Processes

Study Officials

  • Dejan Reljic, Dr.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR
  • Yurdaguel Zopf, Prof.

    University Erlangen Nuremberg Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment parallel-group, randomized-controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2018

First Posted

October 18, 2018

Study Start

October 15, 2018

Primary Completion

October 30, 2021

Study Completion

October 30, 2021

Last Updated

October 18, 2018

Record last verified: 2018-10

Locations