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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; Sports Physical Therapy
• Intervention / Treatment: Behavioral: HIIT+RT experimental group; Behavioral: RT+HIIT experimental group

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 Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Llanquihue
    • Osorno, Llanquihue, Chile, 5290000
      • Cristian ALvarez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Waist circumference	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Systolic blood pressure	Component of metabolic syndrome risk factors	Component of metabolic syndrome risk factors
Diastolic blood pressure	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
High-density lipoprotein cholesterol	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Triglycerides	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass (kg)	Anthropometry parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).	Baseline to 20-weeks of concurrent training
Body mass index (height/m2)	Anthropometry parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Body fat percentage (%)	Anthropometry parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Body fat (kilograms)	Anthropometry parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Skeletal muscle mass (kg)	Body composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).	Baseline to 20-weeks of concurrent training
Lean mass (kg)	Body composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).	Baseline to 20-weeks of concurrent training
Total cholesterol	Metabolic parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Low-density lipoprotein cholesterol	Metabolic parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Handgrip muscle strength (kg)	Physical fitness outcome related with health and intervention effects. This outcome will be measure using a digital dynamometer (BaselineTM Hydraulic Hand Dynamometers, USA),	Baseline to 20-weeks of concurrent training
Six minutes walking test	Physical fitness outcome related with health and intervention effects	Baseline to 20-weeks of concurrent training

Collaborators and Investigators

• Sponsor: Cristian Alvarez
• Collaborators: Universidad de La Frontera
• Investigators: Study Director: Cristian ALvarez, PhD, Universidad de Los Lagos

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): July 6, 2020

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 12, 2021
• First Posted (Actual): June 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 21, 2021
• Last Update Submitted That Met QC Criteria: June 12, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Concurrent training; Exercise training; Morbid obesity; Exercise order
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: RP08042020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participant's information will be available by e-mail according to with researcher's requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No