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

Metabolic Syndrome Clinical Trial

— BELITA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306069
• Other study ID #: BELITA-Study
• Status: Completed
• Phase: N/A
• Start date: November 1, 2017
• Est. completion date: April 15, 2020

Study information

• Verified date: September 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: April 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Overweight
• Overweight and Obesity

Intervention

Other:
• Control
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
• HIIT
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
• MIIT-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
• MIIT-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

Locations

Country	Name	City	State
Germany	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiorespiratory Fitness (CRF)	CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)	12 weeks (baseline to 12 week follow-up assessment)
Secondary	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)
Secondary	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)
Secondary	Insulin sensitivity	Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)	12 weeks (baseline to 12 week follow-up assessment)
Secondary	Inflammation	Inflammation will be assessed by measuring levels of inflammatory blood markers	12 weeks (baseline to 12 week follow-up assessment)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)