Nonresponders by the Session Order Factor

NCT04932642 | Completed DMC

• 1 other identifier: RP08042020
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Sports Physical Therapy

Keywords

Morbid obesity; Exercise training; Metabolic syndrome; Concurrent training; Exercise order

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (10)

• Body mass (kg)

  Baseline to 20-weeks of concurrent training

• Body mass index (height/m2)

  Baseline to 20-weeks of concurrent training

• Body fat percentage (%)

  Baseline to 20-weeks of concurrent training

• Body fat (kilograms)

  Baseline to 20-weeks of concurrent training

• Skeletal muscle mass (kg)

  Baseline to 20-weeks of concurrent training

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

HIIT+RT experimental group BEHAVIORAL

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

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

RT+HIIT experimental group BEHAVIORAL

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

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Cristian Alvarez: lead
• Universidad de La Frontera: collaborator

Study Sites (1)

Cristian ALvarez

Osorno, Llanquihue, 5290000, Chile

Location

MeSH Terms

Conditions

Obesity, Morbid; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Cristian Alvarez, PhD

  Universidad de Los Lagos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 21, 2021
• Study Start: March 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: July 6, 2020
• Last Updated: June 21, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)