Nonresponders by the Session Order Factor

Sponsor

Cristian Alvarez (Other)

Overall Status

Completed

CT.gov ID

NCT04932642

Collaborator

Universidad de La Frontera (Other)

Enrollment

Location

Arms

16.2

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity Sports Physical Therapy	Behavioral: HIIT+RT experimental group Behavioral: RT+HIIT experimental group	N/A

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).

Study Design

Study Type:

Interventional

Actual Enrollment :

43 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Double (Participant, 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.

Primary Purpose:

Prevention

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

Actual Study Start Date :

Mar 1, 2019

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Jul 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: High-intensity interval training plus resistance training (HIIT+RT) The HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points. Second, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting the following different muscle groups: (1) forearm, (2) knee flexors and extensors, (3) trunk, (4) chest, (5) shoulder elevators, (6) horizontal shoulder flexors, (7) extensors, and finally (8) plantar flexors. These exercises were performed in three 3 sets of as many repetitions as possible in 60 seconds, followed by 60 to 120 seconds of passive recovery.	Behavioral: HIIT+RT experimental group Each experimental group will be compared with their another contrast order session group
Experimental: Resistance training plus High-intensity interval training (RT+HIIT) Firstly, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting the following different muscle groups: (1) forearm, (2) knee flexors and extensors, (3) trunk, (4) chest, (5) shoulder elevators, (6) horizontal shoulder flexors, (7) extensors, and finally (8) plantar flexors. These exercises were performed in three 3 sets of 60 seconds, followed by 60 to 120 seconds of passive recovery, as previously reported. Secondly, in the HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points.	Behavioral: RT+HIIT experimental group Each experimental group will be compared with their another contrast order session group

Arm

Intervention/Treatment

Experimental: High-intensity interval training plus resistance training (HIIT+RT)

The HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points. Second, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting the following different muscle groups: (1) forearm, (2) knee flexors and extensors, (3) trunk, (4) chest, (5) shoulder elevators, (6) horizontal shoulder flexors, (7) extensors, and finally (8) plantar flexors. These exercises were performed in three 3 sets of as many repetitions as possible in 60 seconds, followed by 60 to 120 seconds of passive recovery.

Behavioral: HIIT+RT experimental group

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

Experimental: Resistance training plus High-intensity interval training (RT+HIIT)

Firstly, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting the following different muscle groups: (1) forearm, (2) knee flexors and extensors, (3) trunk, (4) chest, (5) shoulder elevators, (6) horizontal shoulder flexors, (7) extensors, and finally (8) plantar flexors. These exercises were performed in three 3 sets of 60 seconds, followed by 60 to 120 seconds of passive recovery, as previously reported. Secondly, in the HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points.

Behavioral: RT+HIIT experimental group

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

Outcome Measures

Primary Outcome Measures

Fasting glucose [Baseline to 20-weeks of concurrent training]
Component of metabolic syndrome risk factors
Waist circumference [Baseline to 20-weeks of concurrent training]
Component of metabolic syndrome risk factors
Systolic blood pressure [Component of metabolic syndrome risk factors]
Component of metabolic syndrome risk factors
Diastolic blood pressure [Baseline to 20-weeks of concurrent training]
Component of metabolic syndrome risk factors
High-density lipoprotein cholesterol [Baseline to 20-weeks of concurrent training]
Component of metabolic syndrome risk factors
Triglycerides [Baseline to 20-weeks of concurrent training]
Component of metabolic syndrome risk factors

Secondary Outcome Measures

Body mass (kg) [Baseline to 20-weeks of concurrent training]
Anthropometry 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 training]
Anthropometry parameter related with health and intervention effects
Body fat percentage (%) [Baseline to 20-weeks of concurrent training]
Anthropometry parameter related with health and intervention effects
Body fat (kilograms) [Baseline to 20-weeks of concurrent training]
Anthropometry parameter related with health and intervention effects
Skeletal muscle mass (kg) [Baseline to 20-weeks of concurrent training]
Body 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 training]
Body composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Total cholesterol [Baseline to 20-weeks of concurrent training]
Metabolic parameter related with health and intervention effects
Low-density lipoprotein cholesterol [Baseline to 20-weeks of concurrent training]
Metabolic parameter related with health and intervention effects
Handgrip muscle strength (kg) [Baseline to 20-weeks of concurrent training]
Physical 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 test [Baseline to 20-weeks of concurrent training]
Physical fitness outcome related with health and intervention effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)