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Trial record 14 of 95 for:    body | Recruiting, Not yet recruiting, Available Studies | "Metabolic Syndrome X"

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

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ClinicalTrials.gov Identifier: NCT03306069
Recruitment Status : Recruiting
First Posted : October 10, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel 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 : November 1, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


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
  • session 1: 2x4 min / session 2: 5x1 min, each at 85-95% 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
  • session 1: 2x4 min / session 2: 5x1 min, each at 65-75% 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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body Mass Index >25
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03306069


Contacts
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Contact: Dejan Reljic, Dr. +49 9131 8545218 dejan.reljic@uk-erlangen.de
Contact: Yurdaguel Zopf, Prof. +49 9131 8545218 yurdaguel.zopf@uk-erlangen.de

Locations
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Germany
Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports, Recruiting
Erlangen, Germany, 91052
Contact: Dejan Reljic, Dr.    +49 9131 8545218    dejan.reljic@uk-erlangen.de   
Contact: Yurdaguel Zopf, Prof.    +49 9131 8545218    yurdaguel.zopf@uk-erlangen.de   
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Investigators
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Principal Investigator: Dejan Reljic, Dr. University Erlangen Nuremberg Medical School
Principal Investigator: Yurdaguel Zopf, Prof. University Erlangen Nuremberg Medical School

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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT03306069     History of Changes
Other Study ID Numbers: BELITA-Study
First Posted: October 10, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

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

Keywords provided by University of Erlangen-Nürnberg Medical School:
Aerobic exercise
Interval training
VO2max
Health Promotion
Inflammation
Body Composition

Additional relevant MeSH terms:
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Overweight
Metabolic Syndrome
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases