Interindividual Postexercise Hypotension Response in Morbid Obesity

Metabolic Syndrome Clinical Trial

Official title:

Characterizing The Interindividual Postexercise Hypotension Response For Two Order of Concurrent Training In Patients With Morbid Obesity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05504629
• Other study ID #: UNAB-FCR-KINE2022A
• Status: Completed
• Phase: N/A
• Start date: March 5, 2019
• Est. completion date: October 5, 2019

Study information

• Verified date: August 2022
• Source: Universidad Nacional Andres Bello
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypotension
• Metabolic Syndrome
• Morbid Obesity
• Obesity
• Obesity, Morbid
• Post-Exercise Hypotension

Intervention

Behavioral:
• Concurrent training order 1
atag
• RT+ET
aetaer

Locations

Country	Name	City	State
Chile	Universidad de La Frontera	Temuco

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Nacional Andres Bello	Universidad de La Frontera

Country where clinical trial is conducted

Chile, 

References & Publications (3)

Álvarez C, Ramírez-Campillo R, Ramírez-Vélez 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;1 — View Citation

Delgado-Floody P, Izquierdo M, Ramírez-Vélez R, Caamaño-Navarrete F, Moris R, Jerez-Mayorga D, Andrade DC, Álvarez C. Effect of High-Intensity Interval Training on Body Composition, Cardiorespiratory Fitness, Blood Pressure, and Substrate Utilization Duri — View Citation

Delgado-Floody P, Soriano-Maldonado A, Rodríguez-Pérez MA, Latorre-Román PÁ, Martínez-Salazar C, Vargas CA, Caamaño-Navarrete F, Jerez-Mayorga D, Álvarez C. The Effects of Two Different Concurrent Training Configurations on Markers of Metabolic Syndrome a — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Heart rate at rest measured by a cardiometer watch	Change from Baseline in Heart rate at rest in (beats per minute)	From baseline to 10 minutes after exercise training
Secondary	Pulse pressure measured by a blood pressure cuff	Change from Baseline in Pulse pressure in the unit of (mmHg)	From baseline to 10 minutes after exercise training
Secondary	Body mass measured by a scale	Change from Baseline in Body mass in (kg)	From baseline to 10 minutes after exercise training
Secondary	Body mass index calculated from weight plus height and elevated to square	Change from Baseline in Body mass index in (kg/m2)	From baseline to 10 minutes after exercise training
Secondary	Waist circumference measured by a flexible tape	Change from Baseline in Waist circumference in (cm)	From baseline to 10 minutes after exercise training
Secondary	Body fat percentage measured by a digital bioimpedanciometer scale	Change from Baseline in Body fat percentage in (%)	From baseline to 10 minutes after exercise training
Secondary	Lean mass measured by a digital bioimpedanciometer scale	Change from Baseline in Body fat percentage in (kg)	From baseline to 10 minutes after exercise training
Secondary	Skeletal muscle mass measured by a digital bioimpedanciometer scale	Change from Baseline in Skeletal muscle mass in (kg)	From baseline to 10 minutes after exercise training
Secondary	Bone mass measured by a digital bioimpedanciometer scale	Change from Baseline in Bone mass in (kg)	From baseline to 10 minutes after exercise training
Secondary	Basal metabolic rate measured by a digital bioimpedanciometer scale	Change from Baseline in Basal metabolic rate in (Kcal)	From baseline to 10 minutes after exercise training
Secondary	Fasting plasma glucose measured by blood sample in fasting state	Change from Baseline in Fasting plasma glucose in (mg/dL)	From baseline to 10 minutes after exercise training
Secondary	Total cholesterol measured by blood sample in fasting state	Change from Baseline in Total cholesterol in (mg/dL)	From baseline to 10 minutes after exercise training
Secondary	Low density lipids measured by blood sample in fasting state	Change from Baseline in Low density lipids in (mg/dL)	From baseline to 10 minutes after exercise training
Secondary	High density lipids measured by blood sample in fasting state	Change from Baseline in High density lipids in (mg/dL)	From baseline to 10 minutes after exercise training
Secondary	Triglycerides measured by blood sample in fasting state	Change from Baseline in Triglycerides in (mg/dL)	From baseline to 10 minutes after exercise training
Secondary	Six minutes walking test measured by a walking test into a sport court	Change from Baseline in Six minutes walking test in (m)	From baseline to 10 minutes after exercise training
Secondary	Handgrip muscle strength of the non-dominant arm measured by a dynamometer hand equipment	Change from Baseline in Handgrip strength in the non-dominant arm measured by dynamometer at sitting position in (kg)	From baseline to 10 minutes after exercise training
Secondary	Handgrip strength Dominant arm measured by a dynamometer hand equipment	Change from Baseline in Handgrip strength in the Dominant arm measured by dynamometer at sitting position in (kg)	From baseline to 10 minutes after exercise training