Clinical trial NCT03710447: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Overweight and Obesity
Metabolic Syndrome
Keywords: Cardiometabolic Health
Cardiorespiratory Fitness
Muscular Strength
Body Composition
Inflammation
Aerobic Exercise
Resistance Exercise
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment parallel-group, randomized-controlled study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Metabolic Syndrome Z-Score (MetS-Z-Score).
timeFrame: 12 weeks
measure: Change in overall Physical Fitness Score (PFS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change in Body Composition
timeFrame: 12 weeks
measure: Change in HOMA-IR
timeFrame: 12 week
measure: Change Inflammation status
timeFrame: 12 weeks
measure: Change in Health-related quality of life
timeFrame: 12 weeks
measure: Change in Pain scores
timeFrame: 12 weeks
measure: Change in Perceived stress
timeFrame: 12 weeks
measure: Change Subjective work ability
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Friedrich-Alexander-University Erlangen-Nuremberg
Study officials:
affiliation: University Erlangen Nuremberg Medical School
name: Dejan Reljic, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Erlangen Nuremberg Medical School
name: Yurdaguel Zopf, Prof.
role: PRINCIPAL_INVESTIGATOR
References: