Skip to main content
OpenTrials
Completed

NCT Number: NCT03306069

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Overweight and Obesity Body Weight Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,

Erlangen, 91052, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Control

Other

Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks

HIIT

Other

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

Other

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

Other

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

Primary outcomes

  1. Cardiorespiratory Fitness (CRF)

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

    CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)

Secondary outcomes

  1. 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.

  2. 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)

  3. Insulin sensitivity

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

    Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)

  4. Inflammation

    Time frame: 12 weeks (baseline to 12 week follow-up assessment)

    Inflammation will be assessed by measuring levels of inflammatory blood markers

  5. 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

  6. 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)

  7. 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)

  8. 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)

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Registry information

Official study 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

Acronym: BELITA

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 10, 2017
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.