Nonresponders by the Session Order Factor

NCT ID: NCT04932642

Last Updated: 2021-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-07-06

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).

Conditions

Morbid Obesity; Sports Physical Therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

HIIT+RT experimental group

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

RT+HIIT experimental group

Intervention Type: BEHAVIORAL

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

Interventions

HIIT+RT experimental group

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

Intervention Type: BEHAVIORAL

RT+HIIT experimental group

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de La Frontera

OTHER

Sponsor Role: collaborator

Cristian Alvarez

OTHER

Sponsor Role: lead

Responsible Party

Cristian Alvarez

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Cristian Alvarez, PhD

Role: STUDY_DIRECTOR

Universidad de Los Lagos

Locations

Cristian ALvarez

Osorno, Llanquihue, Chile

Countries

Chile

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

RP08042020

Identifier Type: -

Identifier Source: org_study_id