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

Primary Purpose

Overweight and Obesity, Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Control
HIIT
MIIT-HR
MIIT-LT
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overweight and Obesity focused on measuring Aerobic exercise, Interval training, VO2max, Health Promotion, Inflammation, Body Composition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Control

HIIT

MIIT-HR

MIIT-LT

Arm Description

Nutritional therapy / no exercise

High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy

Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy

Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding ~70-75% HRmax) combined with Nutritional therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Body Composition
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Insulin sensitivity
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Inflammation
Inflammation will be assessed by measuring levels of inflammatory blood markers
Health-related quality of life
Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
Pain scores
Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
Perceived stress
Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
Subjective work ability
Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)

Full Information

First Posted
September 27, 2017
Last Updated
September 10, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT03306069
Brief Title
Effects of Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight and Obesity, Metabolic Syndrome
Keywords
Aerobic exercise, Interval training, VO2max, Health Promotion, Inflammation, Body Composition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment parallel-group, randomized-controlled study
Masking
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).
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Experimental
Arm Description
Nutritional therapy / no exercise
Arm Title
HIIT
Arm Type
Experimental
Arm Description
High-intensity interval training (HIIT) at 90% heart rate maximum (HRmax) combined with Nutritional therapy
Arm Title
MIIT-HR
Arm Type
Experimental
Arm Description
Heart rate based moderate-intensity interval training (MIIT-HR) at 70% heart rate maximum (HRmax) combined with Nutritional therapy
Arm Title
MIIT-LT
Arm Type
Experimental
Arm Description
Lactate threshold based moderate-intensity interval training (MIIT-LT) at 105% of lactate threshold (corresponding ~70-75% HRmax) combined with Nutritional therapy
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
Intervention Type
Other
Intervention Name(s)
HIIT
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
MIIT-HR
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
MIIT-LT
Intervention Description
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 Outcome Measure Information:
Title
Cardiorespiratory Fitness (CRF)
Description
CRF will be assessed by measuring Maximum Oxygen uptake (VO2max)
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Secondary Outcome Measure Information:
Title
Metabolic Syndrome Z-Score (MetS-Z-Score)
Description
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.
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Title
Body Composition
Description
Muscle mass, fat mass and body water will be measured by Bioelectrical Impedance Analysis (BIA)
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Title
Insulin sensitivity
Description
Insulin sensitivity will be estimated using homeostasis model assessment index (HOMA)
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Title
Inflammation
Description
Inflammation will be assessed by measuring levels of inflammatory blood markers
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Title
Health-related quality of life
Description
Health-related quality of life will be assessed by using the standardized and validated EQ-5D-5L Questionnaire
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Title
Pain scores
Description
Pain scores will be assessed by using the standardized and validated Chronic Pain Grade Questionnaire (CPGQ)
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Title
Perceived stress
Description
Perceived stress will be assessed by using the standardized and validated Perceived Stress Questionnaire (PSQ)
Time Frame
12 weeks (baseline to 12 week follow-up assessment)
Title
Subjective work ability
Description
Subjective work ability will be assessed by using the standardized and validated Work Ability Index Questionnaire (WAI)
Time Frame
12 weeks (baseline to 12 week follow-up assessment)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dejan Reljic, Dr.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yurdaguel Zopf, Prof.
Organizational Affiliation
University Erlangen Nuremberg Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,
City
Erlangen
ZIP/Postal Code
91052
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33160382
Citation
Reljic D, Frenk F, Herrmann HJ, Neurath MF, Zopf Y. Low-volume high-intensity interval training improves cardiometabolic health, work ability and well-being in severely obese individuals: a randomized-controlled trial sub-study. J Transl Med. 2020 Nov 7;18(1):419. doi: 10.1186/s12967-020-02592-6.
Results Reference
derived

Learn more about this trial

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

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