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

Not Applicable

Completed

• Conditions: Overweight and Obesity; Metabolic Syndrome
• Interventions: Other: HIIT; Other: MIIT-HR; Other: Control; Other: MIIT-LT

• Registration Number: NCT03306069
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-27
• Study First Submitted QC: 2017-10-09
• Study First Posted: 2017-10-10
• Study Start: 2017-11-01
• Primary Completion: 2020-02-15
• Study Completion: 2020-04-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HIIT	HIIT	High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy
MIIT-HR	MIIT-HR	Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy
Control	Control	Nutritional therapy / no exercise
MIIT-LT	MIIT-LT	Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding \~70-75% HRmax) combined with Nutritional therapy

Primary Outcome Measures

Name	Time	Method
Cardiorespiratory Fitness (CRF)	12 weeks (baseline to 12 week follow-up assessment)	CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)

Secondary Outcome Measures

Name	Time	Method
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.
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
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
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)

Trial Locations

Locations (1)

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,; 🇩🇪 Erlangen, Germany