An interventional study of Control and HIIT in Overweight and Obesity and Metabolic Syndrome, sponsored by University of Erlangen-Nürnberg Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-14.
Sponsored by University of Erlangen-Nürnberg Medical School · Not applicable, Interventional, and Treatment
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 154 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →University of Erlangen-Nürnberg Medical School is the lead sponsor of 276 studies on the registry; 52 are open to participants now.
Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nutritional therapy / no exercise
Other: Control
High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy
Other: HIIT
Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy
Other: MIIT-HR
Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding \~70-75% HRmax) combined with Nutritional therapy
Other: MIIT-LT
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
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
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
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
Cardiorespiratory Fitness (CRF)
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
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.
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Body Composition
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Insulin sensitivity
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
Inflammation
Inflammation will be assessed by measuring levels of inflammatory blood markers
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 weeks (baseline to 12 week follow-up assessment)
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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University of Erlangen-Nürnberg Medical School →