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

Sponsor

University of Erlangen-Nürnberg Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT03306069

Collaborator

(none)

154

Enrollment

Location

Arms

29.4

Actual Duration (Months)

5.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight and Obesity Metabolic Syndrome	Other: Control Other: HIIT Other: MIIT-HR Other: MIIT-LT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

154 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel Assignment parallel-group, randomized-controlled studyParallel Assignment parallel-group, randomized-controlled study

Masking:

Single (Outcomes Assessor)

Masking Description:

Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 1, 2017

Actual Primary Completion Date :

Feb 15, 2020

Actual Study Completion Date :

Apr 15, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,	Erlangen		Germany	91052

Sponsors and Collaborators

University of Erlangen-Nürnberg Medical School

Investigators

Principal Investigator: Dejan Reljic, Dr., University Erlangen Nuremberg Medical School
Principal Investigator: Yurdaguel Zopf, Prof., University Erlangen Nuremberg Medical School