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Nonresponders by the Session Order Factor

The Effects of Two Different Orders of Concurrent Training on the Interindividual Variability of Health Markers of Metabolic Syndrome and Fitness in Severe/Morbidly Obesity Women. A Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04932642
Enrollment
43
Registered
2021-06-21
Start date
2019-03-01
Completion date
2020-07-06
Last updated
2021-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity, Sports Physical Therapy

Keywords

Morbid obesity, Exercise training, Metabolic syndrome, Concurrent training, Exercise order

Brief summary

Concurrent training (CT, characterised by the inclusion of two exercise modalities), is recognised to improve metabolic syndrome (MetS) markers, but little is known about order session effect on interindividual variability. The purpose of the present study was to describe the effects, and the interindividual variability, of 20 weeks of CT in different order at (i.e., high intensity interval training (HIIT) plus resistance training (RT), compared with another group doing RT plus HIIT) in women with severe/morbidly obesity at risk of MetS.

Detailed description

Morbid obesity, defined as a body mass index (BMI) of 40 kg/m2 (class III obesity), is a chronic disease with life-threatening cardiometabolic consequences such as elevated blood pressure (systolic \[SBP\] or diastolic BP \[DBP\]), fasting plasma glucose (FPG), triglycerides (Tg), and low high-density lipoprotein cholesterol (HDL-c), all summarised as metabolic syndrome (MetS). In this sense, exercise training as resistance training (RT), defined as any exercise that causes voluntary skeletal muscle contraction by using external weights such as dumbbells and metal bars, is a known non-pharmacotherapy strategy for improving muscle strength and functional capacity in obese patients undergoing bariatric surgery. Similarly, high-intensity interval training (HIIT), defined as several and brief bouts of high-intensity effort usually by cycling/running, interspersed by recovery periods ), has produced strong evidence for the improvement of cardiometabolic risk factors for type 2 diabetes mellitus, arterial hypertension, central arterial stiffness and, vascular function, and cardiorespiratory fitness. Thus, in individuals with morbid obesity, for example, exercise training has proven to be effective for inducing clinically significant weight loss (5-10%), and for the reduction of cardiovascular risk, following the standard recommendations for these cohorts prior to bariatric surgical. However, some inconsistencies have been described after CT, which are directly concerned with the 'order' (i.e. starting the CT session with MICT followed by RT, or vice versa) of the CT session. However, little is known about the interindividual variability of exercise training (IVET) in relation to different order sessions of CT in morbidly obese populations and health-related outcomes, such as MetS markers. Briefly, IVET means that some subjects achieve benefits after training, and are termed responders (Rs), while others exhibit a worsened or unchanged response, and that is commonly known termed as nonresponders (NRs).

Interventions

BEHAVIORALHIIT+RT experimental group

Each experimental group will be compared with their another contrast order session group

BEHAVIORALRT+HIIT experimental group

Each experimental group will be compared with their another contrast order session group

Sponsors

Universidad de La Frontera
CollaboratorOTHER
Cristian Alvarez
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)

Masking description

According to availability and the feasibility of the enrolment's requirements, patients will be allocated to aHIIT+RT group with morbid obesity, or to another exercise group of RT+HIIT with morbid obesity.

Intervention model description

We will compare a concurrent training group (HIIT+RT) with morbid obesity with another experimental group of concurrent training with morbid obesity, but with another exercise order (RT+HIIT).

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* being a candidate for bariatric surgery * aged between 18 and 60 years * tobe medically authorised * with a body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2 * with additional comorbidities (i.e. diabetes, hypertension, insulin resistance) controlled by pharmacotherapy

Exclusion criteria

* having physical limitations preventing the performance of exercise (e.g. restricting injuries of the musculoskeletal system) * having exercise-related dyspnoea or respiratory alterations * having chronic heart disease with any worsening in the last month * adhering to less than 80% of the total interventions (these results were excluded from the statistical analyses)

Design outcomes

Primary

MeasureTime frameDescription
Fasting glucoseBaseline to 20-weeks of concurrent trainingComponent of metabolic syndrome risk factors
Waist circumferenceBaseline to 20-weeks of concurrent trainingComponent of metabolic syndrome risk factors
Systolic blood pressureComponent of metabolic syndrome risk factorsComponent of metabolic syndrome risk factors
Diastolic blood pressureBaseline to 20-weeks of concurrent trainingComponent of metabolic syndrome risk factors
High-density lipoprotein cholesterolBaseline to 20-weeks of concurrent trainingComponent of metabolic syndrome risk factors
TriglyceridesBaseline to 20-weeks of concurrent trainingComponent of metabolic syndrome risk factors

Secondary

MeasureTime frameDescription
Body mass (kg)Baseline to 20-weeks of concurrent trainingAnthropometry parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Body mass index (height/m2)Baseline to 20-weeks of concurrent trainingAnthropometry parameter related with health and intervention effects
Body fat percentage (%)Baseline to 20-weeks of concurrent trainingAnthropometry parameter related with health and intervention effects
Body fat (kilograms)Baseline to 20-weeks of concurrent trainingAnthropometry parameter related with health and intervention effects
Skeletal muscle mass (kg)Baseline to 20-weeks of concurrent trainingBody composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Lean mass (kg)Baseline to 20-weeks of concurrent trainingBody composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Total cholesterolBaseline to 20-weeks of concurrent trainingMetabolic parameter related with health and intervention effects
Low-density lipoprotein cholesterolBaseline to 20-weeks of concurrent trainingMetabolic parameter related with health and intervention effects
Handgrip muscle strength (kg)Baseline to 20-weeks of concurrent trainingPhysical fitness outcome related with health and intervention effects. This outcome will be measure using a digital dynamometer (BaselineTM Hydraulic Hand Dynamometers, USA),
Six minutes walking testBaseline to 20-weeks of concurrent trainingPhysical fitness outcome related with health and intervention effects

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026