Clinical trial NCT03306069: Effects of Low-volume Aerobic Interval Training in Overweight Individuals at Increased Cardiometabolic Risk
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
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Metabolic Syndrome
Keywords: Aerobic exercise
Interval training
VO2max
Health Promotion
Inflammation
Body Composition
Lead sponsor: University of Erlangen-Nürnberg Medical School
Sponsor class: OTHER
First posted: 2017-10-10
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment parallel-group, randomized-controlled study
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Cardiorespiratory Fitness (CRF)
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
Secondary outcomes:
measure: Metabolic Syndrome Z-Score (MetS-Z-Score)
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
measure: Body Composition
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
measure: Insulin sensitivity
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
measure: Inflammation
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
measure: Health-related quality of life
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
measure: Pain scores
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
measure: Perceived stress
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
measure: Subjective work ability
timeFrame: 12 weeks (baseline to 12 week follow-up assessment)
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: Department of Medicine 1, Hector Center for Nutrition, Exercise and Sports,
Study officials:
affiliation: University Erlangen Nuremberg Medical School
name: Dejan Reljic, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University Erlangen Nuremberg Medical School
name: Yurdaguel Zopf, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.