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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Experimental | Nutritional therapy / no exercise |
|
| HIIT | Experimental | High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy |
|
| MIIT-HR | Experimental | Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy |
|
| MIIT-LT | Experimental | Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding ~70-75% HRmax) combined with Nutritional therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Other | Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cardiorespiratory Fitness (CRF) | CRF will be assessed by measuring Maximum Oxygen uptake (VO2max) | 12 weeks (baseline to 12 week follow-up assessment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 (baseline to 12 week follow-up assessment) |
| Body Composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dejan Reljic, Dr. | University Erlangen Nuremberg Medical School | Principal Investigator |
| Yurdaguel Zopf, Prof. | University Erlangen Nuremberg Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, | Erlangen | 91052 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33160382 | Derived | Reljic D, Frenk F, Herrmann HJ, Neurath MF, Zopf Y. Low-volume high-intensity interval training improves cardiometabolic health, work ability and well-being in severely obese individuals: a randomized-controlled trial sub-study. J Transl Med. 2020 Nov 7;18(1):419. doi: 10.1186/s12967-020-02592-6. |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D024821 | Metabolic Syndrome |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Parallel Assignment parallel-group, randomized-controlled study
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Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).
| HIIT | Other | 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:
|
|
| MIIT-HR | Other | 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:
|
|
| MIIT-LT | Other | 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:
|
|
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA) |
| 12 weeks (baseline to 12 week follow-up assessment) |
| Insulin sensitivity | Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA) | 12 weeks (baseline to 12 week follow-up assessment) |
| Inflammation | Inflammation will be assessed by measuring levels of inflammatory blood markers | 12 weeks (baseline to 12 week follow-up assessment) |
| Health-related quality of life | Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire | 12 weeks (baseline to 12 week follow-up assessment) |
| Pain scores | Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ) | 12 weeks (baseline to 12 week follow-up assessment) |
| Perceived stress | Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ) | 12 weeks (baseline to 12 week follow-up assessment) |
| Subjective work ability | Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI) | 12 weeks (baseline to 12 week follow-up assessment) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D010335 | Pathologic Processes |