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

September 10, 2020 updated by: University of Erlangen-Nürnberg Medical School

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiorespiratory Fitness (CRF)
Time Frame: 12 weeks (baseline to 12 week follow-up assessment)
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)
Time Frame: 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.
12 weeks (baseline to 12 week follow-up assessment)
Body Composition
Time Frame: 12 weeks (baseline to 12 week follow-up assessment)
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
12 weeks (baseline to 12 week follow-up assessment)
Health-related quality of life
Time Frame: 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
12 weeks (baseline to 12 week follow-up assessment)
Pain scores
Time Frame: 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)
12 weeks (baseline to 12 week follow-up assessment)
Perceived stress
Time Frame: 12 weeks (baseline to 12 week follow-up assessment)
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
Time Frame: 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)
12 weeks (baseline to 12 week follow-up assessment)
Insulin sensitivity
Time Frame: 12 weeks (baseline to 12 week follow-up assessment)
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
12 weeks (baseline to 12 week follow-up assessment)
Inflammation
Time Frame: 12 weeks (baseline to 12 week follow-up assessment)
Inflammation will be assessed by measuring levels of inflammatory blood markers
12 weeks (baseline to 12 week follow-up assessment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2017

Primary Completion (ACTUAL)

February 15, 2020

Study Completion (ACTUAL)

April 15, 2020

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

October 9, 2017

First Posted (ACTUAL)

October 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2020

Last Update Submitted That Met QC Criteria

September 10, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BELITA-Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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