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

NCT03306069 | Completed

• 1 other identifier: BELITA-Study
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight and Obesity; Metabolic Syndrome

Keywords

Aerobic exercise; Interval training; VO2max; Health Promotion; Inflammation; Body Composition

Outcome Measures

Primary Outcomes (1)

• Cardiorespiratory Fitness (CRF)

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

  12 weeks (baseline to 12 week follow-up assessment)

Secondary Outcomes (8)

• Metabolic Syndrome Z-Score (MetS-Z-Score)

  12 weeks (baseline to 12 week follow-up assessment)

• Body Composition

  12 weeks (baseline to 12 week follow-up assessment)

• Insulin sensitivity

  12 weeks (baseline to 12 week follow-up assessment)

• Inflammation

  12 weeks (baseline to 12 week follow-up assessment)

• Health-related quality of life

  12 weeks (baseline to 12 week follow-up assessment)

Study Arms (4)

Control

EXPERIMENTAL

Nutritional therapy / no exercise

Other: Control

HIIT

EXPERIMENTAL

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

Other: HIIT

MIIT-HR

EXPERIMENTAL

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

Other: MIIT-HR

MIIT-LT

EXPERIMENTAL

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

Interventions

Control OTHER

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

Control

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

HIIT

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-HR

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

MIIT-LT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index \>/=30
• presence of at least 2 cardiometabolic risk factors

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

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

Erlangen, 91052, Germany

Location

Related Publications (1)

• 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.

  PMID: 33160382 DERIVED

MeSH Terms

Conditions

Overweight; Obesity; Metabolic Syndrome; Inflammation

Condition Hierarchy (Ancestors)

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

Study Officials

• Dejan Reljic, Dr.

  University Erlangen Nuremberg Medical School

  PRINCIPAL INVESTIGATOR

• Yurdaguel Zopf, Prof.

  University Erlangen Nuremberg Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome Assessors involved in data analysis will not be aware of the arm to which the participants were allocated (single-blinded masking).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel Assignment parallel-group, randomized-controlled study

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: October 10, 2017
• Study Start: November 1, 2017
• Primary Completion: February 15, 2020
• Study Completion: April 15, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-09

Locations

DE (1)