NCT05504629

Brief Summary

A quasi-experimental study developed in sedentary morbidly obese men and women (age 43.6±11.3 y; body mass index \[BMI\] ≥40 kg/m2) were assigned to a CT group of ET plus RT (ET+RT; n=19; BMI 47.8±16.7) or RT plus ET order group (RT+ET; n=17; BMI 43.0±8.0). Subjects of both groups received eight exercise sessions over four weeks. Systolic (SBP), diastolic (DBP), mean arterial pressure \[MAP\], heart rate at rest \[HR\], and pulse pressure \[PP\] measurements before and after 10 minutes postexercise. Secondary outcomes were other anthropometric, body composition, metabolic, and physical condition parameters. Using the ∆SBP reduction, and quartile categorization (Q) in 'high' (Rs: quartile 4), 'moderate' (MRs: quartile 3), 'low' (LRs: quartile 2), and 'nonresponders' (NRs: quartile 1) were reported.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 17, 2022

Completed
Last Updated

August 24, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

August 13, 2022

Last Update Submit

August 19, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Systolic blood pressure measured by a blood pressure cuff

    Change from Baseline in systolic blood pressure in the unit of (mmHg)

    From baseline to 10 minutes after exercise training

  • Diastolic blood pressure measured by a blood pressure cuff

    Change from Baseline in diastolic blood pressure in the unit of (mmHg)

    From baseline to 10 minutes after exercise training

  • Mean arterial pressure measured by a blood pressure cuff

    Change from Baseline in mean arterial blood pressure in the unit of (mmHg)

    From baseline to 10 minutes after exercise training

Secondary Outcomes (18)

  • Heart rate at rest measured by a cardiometer watch

    From baseline to 10 minutes after exercise training

  • Pulse pressure measured by a blood pressure cuff

    From baseline to 10 minutes after exercise training

  • Body mass measured by a scale

    From baseline to 10 minutes after exercise training

  • Body mass index calculated from weight plus height and elevated to square

    From baseline to 10 minutes after exercise training

  • Waist circumference measured by a flexible tape

    From baseline to 10 minutes after exercise training

  • +13 more secondary outcomes

Study Arms (2)

Endurance Training (ET) plus Resistance Training (RT)

EXPERIMENTAL

Concurrent training of Endurance Training plus Resistance Training order.

Behavioral: RT+ET

Resistance Training (RT) plus Endurance Training (ET)

ACTIVE COMPARATOR

Concurrent training of Resistance Training plus Endurance Training order.

Behavioral: Concurrent training order 1

Interventions

atag

Also known as: Exercise training
Resistance Training (RT) plus Endurance Training (ET)
RT+ETBEHAVIORAL

aetaer

Also known as: Concurrent training order 2
Endurance Training (ET) plus Resistance Training (RT)

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age \>18 and \<60 years
  • women or men
  • medical authorization for physical tests
  • body mass index (BMI) ≥40 kg/m2, or between 35 and 40 kg/m2 but with previously diagnosed of morbid obesity and candidate for bariatric surgery

You may not qualify if:

  • physical limitations to performing the physical test (e.g., restrictive injuries of the musculoskeletal system)
  • exercise-related dyspnoea or respiratory alterations
  • chronic heart disease diagnosed during the time of morbid obesity diagnosed and the starting of the exercise intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de La Frontera

Temuco, Chile

Location

Related Publications (3)

  • Delgado-Floody P, Izquierdo M, Ramirez-Velez R, Caamano-Navarrete F, Moris R, Jerez-Mayorga D, Andrade DC, Alvarez C. Effect of High-Intensity Interval Training on Body Composition, Cardiorespiratory Fitness, Blood Pressure, and Substrate Utilization During Exercise Among Prehypertensive and Hypertensive Patients With Excessive Adiposity. Front Physiol. 2020 Oct 19;11:558910. doi: 10.3389/fphys.2020.558910. eCollection 2020.

  • Delgado-Floody P, Soriano-Maldonado A, Rodriguez-Perez MA, Latorre-Roman PA, Martinez-Salazar C, Vargas CA, Caamano-Navarrete F, Jerez-Mayorga D, Alvarez C. The Effects of Two Different Concurrent Training Configurations on Markers of Metabolic Syndrome and Fitness in Women With Severe/Morbid Obesity: A Randomised Controlled Trial. Front Physiol. 2021 Sep 21;12:694798. doi: 10.3389/fphys.2021.694798. eCollection 2021.

  • Alvarez C, Ramirez-Campillo R, Ramirez-Velez R, Izquierdo M. Effects and prevalence of nonresponders after 12 weeks of high-intensity interval or resistance training in women with insulin resistance: a randomized trial. J Appl Physiol (1985). 2017 Apr 1;122(4):985-996. doi: 10.1152/japplphysiol.01037.2016. Epub 2017 Feb 2.

MeSH Terms

Conditions

Metabolic SyndromeObesity, Morbid

Interventions

Exercise

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Pedro Delgado Floody, PhD

    Universidad de La Frontera

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 13, 2022

First Posted

August 17, 2022

Study Start

March 5, 2019

Primary Completion

September 5, 2019

Study Completion

October 5, 2019

Last Updated

August 24, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations