Clinical trial NCT05504629: Interindividual Postexercise Hypotension Response in Morbid Obesity
Official title: Characterizing The Interindividual Postexercise Hypotension Response For Two Order of Concurrent Training In Patients With Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Morbid Obesity
Lead sponsor: Universidad Nacional Andres Bello
Sponsor class: OTHER
Collaborators: name: Universidad de La Frontera
First posted: 2022-08-17
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Detailed description: Independent of the order (i.e., ET+RT, or RT+ET), each CT session had two sections; RT and ET, which were applied two days per week, during 8 sessions (4 weeks), and where the blood pressure changes were measured only in four opportunities (i.e., once a week in sessions 2, 4, 6, and 8). Thus, the CT included in each session 3 stages; a) callisthenics exercises, b) main exercise (ET+RT or RT+ET), and c) cool down exercises.

Before the starting, the participants were involved in the maximum strength capacity estimated using a submaximal test based on the Brzycki's equation: weight \[1.0278-(0.0278\*repetitions)\] that does not change based on the sex, age of the population, or the exercise modality that is performed (Mayhew et al., 2004). After this procedure, there were applied 4 familiarization sessions that consisted in; session 1: 'knowledge of all measurements', 'knowledge of exercise-machine manipulation', and 'instructions during the exercise program', session 2: 'exercising during cycling', 'weights, and metal bars', session 3: 'applying a few of exercises of RT in 2 to 3 sets of exercises, to know the configuration of each exercise (i.e., ET and RT regimes itself), and session 4: 'applying the 50 to 70% of their CT program' corresponding to a normal session compound. In the 'calisthenic stage', each subject developed 10 minute warm-up with continuous walking, joint mobility and flexibility exercises. In the 'main part' of the session, and independent of the CT order group (ET+RT or RT+ET), the ET section consisted of continuous cycling using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile) for 20 minutes. The intensity of the ET exercise was regulated through the previously used modified Borg scale from 1 to 10 rating of perceived exertion (Gillen et al., 2013) and the participants worked at a level between 5 to 7 points (i.e., moderate-intensity), considering the original 6 to 20 points scale (Borg, 1998), being the subjects regularly controlled to not exceed this intensity restriction. On the other hand, the RT section included 8 to 12 muscle strength exercises of circuit training with 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 one set in a continuous concentric/eccentric voluntary contraction as possible for 60 seconds, followed by 60 to 90 seconds of passive recovery, where each participant was changed to another exercise. The RT section was of 25 minutes in duration time.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Systolic blood pressure measured by a blood pressure cuff
timeFrame: From baseline to 10 minutes after exercise training
measure: Diastolic blood pressure measured by a blood pressure cuff
timeFrame: From baseline to 10 minutes after exercise training
measure: Mean arterial pressure measured by a blood pressure cuff
timeFrame: From baseline to 10 minutes after exercise training
Secondary outcomes:
measure: Heart rate at rest measured by a cardiometer watch
timeFrame: From baseline to 10 minutes after exercise training
measure: Pulse pressure measured by a blood pressure cuff
timeFrame: From baseline to 10 minutes after exercise training
measure: Body mass measured by a scale
timeFrame: From baseline to 10 minutes after exercise training
measure: Body mass index calculated from weight plus height and elevated to square
timeFrame: From baseline to 10 minutes after exercise training
measure: Waist circumference measured by a flexible tape
timeFrame: From baseline to 10 minutes after exercise training
measure: Body fat percentage measured by a digital bioimpedanciometer scale
timeFrame: From baseline to 10 minutes after exercise training
measure: Lean mass measured by a digital bioimpedanciometer scale
timeFrame: From baseline to 10 minutes after exercise training
measure: Skeletal muscle mass measured by a digital bioimpedanciometer scale
timeFrame: From baseline to 10 minutes after exercise training
measure: Bone mass measured by a digital bioimpedanciometer scale
timeFrame: From baseline to 10 minutes after exercise training
measure: Basal metabolic rate measured by a digital bioimpedanciometer scale
timeFrame: From baseline to 10 minutes after exercise training
measure: Fasting plasma glucose measured by blood sample in fasting state
timeFrame: From baseline to 10 minutes after exercise training
measure: Total cholesterol measured by blood sample in fasting state
timeFrame: From baseline to 10 minutes after exercise training
measure: Low density lipids measured by blood sample in fasting state
timeFrame: From baseline to 10 minutes after exercise training
measure: High density lipids measured by blood sample in fasting state
timeFrame: From baseline to 10 minutes after exercise training
measure: Triglycerides measured by blood sample in fasting state
timeFrame: From baseline to 10 minutes after exercise training
measure: Six minutes walking test measured by a walking test into a sport court
timeFrame: From baseline to 10 minutes after exercise training
measure: Handgrip muscle strength of the non-dominant arm measured by a dynamometer hand equipment
timeFrame: From baseline to 10 minutes after exercise training
measure: Handgrip strength Dominant arm measured by a dynamometer hand equipment
timeFrame: From baseline to 10 minutes after exercise training
Other outcomes:
Locations:
city: Temuco
country: Chile
facility: Universidad de La Frontera
Study officials:
affiliation: Universidad de La Frontera
name: Pedro Delgado Floody, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.