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Nonresponders by the Session Order Factor

Primary Purpose

Morbid Obesity, Sports Physical Therapy

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
HIIT+RT experimental group
RT+HIIT experimental group
Sponsored by
Cristian Alvarez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity focused on measuring Morbid obesity, Exercise training, Metabolic syndrome, Concurrent training, Exercise order

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • Cristian ALvarez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Fasting glucose
Component of metabolic syndrome risk factors
Waist circumference
Component of metabolic syndrome risk factors
Systolic blood pressure
Component of metabolic syndrome risk factors
Diastolic blood pressure
Component of metabolic syndrome risk factors
High-density lipoprotein cholesterol
Component of metabolic syndrome risk factors
Triglycerides
Component of metabolic syndrome risk factors

Secondary Outcome Measures

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).
Body mass index (height/m2)
Anthropometry parameter related with health and intervention effects
Body fat percentage (%)
Anthropometry parameter related with health and intervention effects
Body fat (kilograms)
Anthropometry parameter related with health and intervention effects
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).
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).
Total cholesterol
Metabolic parameter related with health and intervention effects
Low-density lipoprotein cholesterol
Metabolic parameter related with health and intervention effects
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),
Six minutes walking test
Physical fitness outcome related with health and intervention effects

Full Information

First Posted
June 2, 2021
Last Updated
June 12, 2021
Sponsor
Cristian Alvarez
Collaborators
Universidad de La Frontera
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1. Study Identification

Unique Protocol Identification Number
NCT04932642
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
July 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristian Alvarez
Collaborators
Universidad de La Frontera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Sports Physical Therapy
Keywords
Morbid obesity, Exercise training, Metabolic syndrome, Concurrent training, Exercise order

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-intensity interval training plus resistance training (HIIT+RT)
Arm Type
Experimental
Arm Description
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.
Arm Title
Resistance training plus High-intensity interval training (RT+HIIT)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
HIIT+RT experimental group
Intervention Description
Each experimental group will be compared with their another contrast order session group
Intervention Type
Behavioral
Intervention Name(s)
RT+HIIT experimental group
Intervention Description
Each experimental group will be compared with their another contrast order session group
Primary Outcome Measure Information:
Title
Fasting glucose
Description
Component of metabolic syndrome risk factors
Time Frame
Baseline to 20-weeks of concurrent training
Title
Waist circumference
Description
Component of metabolic syndrome risk factors
Time Frame
Baseline to 20-weeks of concurrent training
Title
Systolic blood pressure
Description
Component of metabolic syndrome risk factors
Time Frame
Component of metabolic syndrome risk factors
Title
Diastolic blood pressure
Description
Component of metabolic syndrome risk factors
Time Frame
Baseline to 20-weeks of concurrent training
Title
High-density lipoprotein cholesterol
Description
Component of metabolic syndrome risk factors
Time Frame
Baseline to 20-weeks of concurrent training
Title
Triglycerides
Description
Component of metabolic syndrome risk factors
Time Frame
Baseline to 20-weeks of concurrent training
Secondary Outcome Measure Information:
Title
Body mass (kg)
Description
Anthropometry parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Time Frame
Baseline to 20-weeks of concurrent training
Title
Body mass index (height/m2)
Description
Anthropometry parameter related with health and intervention effects
Time Frame
Baseline to 20-weeks of concurrent training
Title
Body fat percentage (%)
Description
Anthropometry parameter related with health and intervention effects
Time Frame
Baseline to 20-weeks of concurrent training
Title
Body fat (kilograms)
Description
Anthropometry parameter related with health and intervention effects
Time Frame
Baseline to 20-weeks of concurrent training
Title
Skeletal muscle mass (kg)
Description
Body composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Time Frame
Baseline to 20-weeks of concurrent training
Title
Lean mass (kg)
Description
Body composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Time Frame
Baseline to 20-weeks of concurrent training
Title
Total cholesterol
Description
Metabolic parameter related with health and intervention effects
Time Frame
Baseline to 20-weeks of concurrent training
Title
Low-density lipoprotein cholesterol
Description
Metabolic parameter related with health and intervention effects
Time Frame
Baseline to 20-weeks of concurrent training
Title
Handgrip muscle strength (kg)
Description
Physical fitness outcome related with health and intervention effects. This outcome will be measure using a digital dynamometer (BaselineTM Hydraulic Hand Dynamometers, USA),
Time Frame
Baseline to 20-weeks of concurrent training
Title
Six minutes walking test
Description
Physical fitness outcome related with health and intervention effects
Time Frame
Baseline to 20-weeks of concurrent training

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian Alvarez, PhD
Organizational Affiliation
Universidad de Los Lagos
Official's Role
Study Director
Facility Information:
Facility Name
Cristian ALvarez
City
Osorno
State/Province
Llanquihue
ZIP/Postal Code
5290000
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The participant's information will be available by e-mail according to with researcher's requirements.

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Nonresponders by the Session Order Factor

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