Clinical trial NCT04932642: Nonresponders by the Session Order Factor
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Sports Physical Therapy
Keywords: Morbid obesity
Exercise training
Metabolic syndrome
Concurrent training
Exercise order
Lead sponsor: Universidad de Los Lagos
Sponsor class: OTHER
Collaborators: name: Universidad de La Frontera
First posted: 2021-06-21
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: PREVENTION

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Fasting glucose
timeFrame: Baseline to 20-weeks of concurrent training
measure: Waist circumference
timeFrame: Baseline to 20-weeks of concurrent training
measure: Systolic blood pressure
timeFrame: Component of metabolic syndrome risk factors
measure: Diastolic blood pressure
timeFrame: Baseline to 20-weeks of concurrent training
measure: High-density lipoprotein cholesterol
timeFrame: Baseline to 20-weeks of concurrent training
measure: Triglycerides
timeFrame: Baseline to 20-weeks of concurrent training
Secondary outcomes:
measure: Body mass (kg)
timeFrame: Baseline to 20-weeks of concurrent training
measure: Body mass index (height/m2)
timeFrame: Baseline to 20-weeks of concurrent training
measure: Body fat percentage (%)
timeFrame: Baseline to 20-weeks of concurrent training
measure: Body fat (kilograms)
timeFrame: Baseline to 20-weeks of concurrent training
measure: Skeletal muscle mass (kg)
timeFrame: Baseline to 20-weeks of concurrent training
measure: Lean mass (kg)
timeFrame: Baseline to 20-weeks of concurrent training
measure: Total cholesterol
timeFrame: Baseline to 20-weeks of concurrent training
measure: Low-density lipoprotein cholesterol
timeFrame: Baseline to 20-weeks of concurrent training
measure: Handgrip muscle strength (kg)
timeFrame: Baseline to 20-weeks of concurrent training
measure: Six minutes walking test
timeFrame: Baseline to 20-weeks of concurrent training
Other outcomes:
Locations:
city: Osorno
country: Chile
facility: Cristian ALvarez
state: Llanquihue
Study officials:
affiliation: Universidad de Los Lagos
name: Cristian Alvarez, PhD
role: STUDY_DIRECTOR
References: