Nonresponders by the Session Order Factor

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04932642
• Other study ID #: RP08042020
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: July 6, 2020

Study information

• Verified date: June 2021
• Source: Universidad de Los Lagos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: July 6, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid
• Sports Physical Therapy

Intervention

Behavioral:
• HIIT+RT experimental group
Each experimental group will be compared with their another contrast order session group
• RT+HIIT experimental group
Each experimental group will be compared with their another contrast order session group

Locations

Country	Name	City	State
Chile	Cristian ALvarez	Osorno	Llanquihue

Sponsors (2)

Lead Sponsor	Collaborator
Cristian Alvarez	Universidad de la Frontera

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Primary	Waist circumference	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Primary	Systolic blood pressure	Component of metabolic syndrome risk factors	Component of metabolic syndrome risk factors
Primary	Diastolic blood pressure	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Primary	High-density lipoprotein cholesterol	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Primary	Triglycerides	Component of metabolic syndrome risk factors	Baseline to 20-weeks of concurrent training
Secondary	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
Secondary	Body mass index (height/m2)	Anthropometry parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Secondary	Body fat percentage (%)	Anthropometry parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Secondary	Body fat (kilograms)	Anthropometry parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Secondary	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
Secondary	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
Secondary	Total cholesterol	Metabolic parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Secondary	Low-density lipoprotein cholesterol	Metabolic parameter related with health and intervention effects	Baseline to 20-weeks of concurrent training
Secondary	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
Secondary	Six minutes walking test	Physical fitness outcome related with health and intervention effects	Baseline to 20-weeks of concurrent training