Effects of Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk

Study Overview
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Brief Summary
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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.

Official Title
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Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk: Impact of Training Intensity on Cardiorespiratory Fitness, Cardiometabolic Risk Profile and Exercise Adherence

Conditions
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Overweight and Obesity, Metabolic Syndrome

Intervention / Treatment
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* Other: Control
* Other: HIIT
* Other: MIIT-HR
* Other: MIIT-LT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment parallel-group, randomized-controlled study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control<br>Nutritional therapy / no exercise | Other: Control<br>* Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks<br>|
| Experimental: HIIT<br>High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy | Other: HIIT<br>* 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<br>|
| Experimental: MIIT-HR<br>Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy | Other: MIIT-HR<br>* 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<br>|
| Experimental: MIIT-LT<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aerobic exercise, Interval training, VO2max, Health Promotion, Inflammation, Body Composition