Metabolic Syndrome, Overweight and Obesity
Conditions
Keywords
Aerobic exercise, Interval training, VO2max, Health Promotion, Inflammation, Body Composition
Brief summary
The main purpose of this study is to compare the impact of aerobic interval training intensity on exercise adherence and changes in cardiorespiratory fitness, cardiometabolic risk profile, body composition, inflammatory markers and subjective health outcomes after a 12-week intervention trial in overweight individuals at increased cardiometabolic risk.
Interventions
OTHERControl
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
OTHERHIIT
Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based high-intensity interval training (HIIT). HIIT: * 2 sessions per week * 5x1 min at 80-95% HRmax * time-effort per week: \ 30 min
OTHERMIIT-HR
Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of HRmax (MIIT-HR). MIIT-HR: * 2 sessions per week * 5x1 min at 65-79% HRmax * time-effort per week: \ 30 min
OTHERMIIT-LT
Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of lactate threshold (MIIT-LT). MIIT-LT: * 2 sessions per week * session 1: 2x4 min / session 2: 5x1 min, each at 105% LT * time-effort per week: \ 30 min
Sponsors
University of Erlangen-Nürnberg Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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).
Intervention model description
Parallel Assignment parallel-group, randomized-controlled study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Body Mass Index \>/=30 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiorespiratory Fitness (CRF) | 12 weeks (baseline to 12 week follow-up assessment) | CRF will be assessed by measuring Maximum Oxygen uptake (VO2max) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body Composition | 12 weeks (baseline to 12 week follow-up assessment) | Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA) |
| Insulin sensitivity | 12 weeks (baseline to 12 week follow-up assessment) | Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA) |
| Inflammation | 12 weeks (baseline to 12 week follow-up assessment) | Inflammation will be assessed by measuring levels of inflammatory blood markers |
| Metabolic Syndrome Z-Score (MetS-Z-Score) | 12 weeks (baseline to 12 week follow-up assessment) | 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. |
| Pain scores | 12 weeks (baseline to 12 week follow-up assessment) | Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ) |
| Perceived stress | 12 weeks (baseline to 12 week follow-up assessment) | Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ) |
| Subjective work ability | 12 weeks (baseline to 12 week follow-up assessment) | Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI) |
| Health-related quality of life | 12 weeks (baseline to 12 week follow-up assessment) | Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire |
Countries
Germany
Outcome results
None listed