- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05504629
Interindividual Postexercise Hypotension Response in Morbid Obesity
Characterizing The Interindividual Postexercise Hypotension Response For Two Order of Concurrent Training In Patients With Morbid Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Temuco, Chile
- Universidad de La Frontera
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Endurance Training (ET) plus Resistance Training (RT)
Concurrent training of Endurance Training plus Resistance Training order.
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aetaer
Other Names:
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ACTIVE_COMPARATOR: Resistance Training (RT) plus Endurance Training (ET)
Concurrent training of Resistance Training plus Endurance Training order.
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atag
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Systolic blood pressure measured by a blood pressure cuff
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in systolic blood pressure in the unit of (mmHg)
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From baseline to 10 minutes after exercise training
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Diastolic blood pressure measured by a blood pressure cuff
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in diastolic blood pressure in the unit of (mmHg)
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From baseline to 10 minutes after exercise training
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Mean arterial pressure measured by a blood pressure cuff
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in mean arterial blood pressure in the unit of (mmHg)
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From baseline to 10 minutes after exercise training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Heart rate at rest measured by a cardiometer watch
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Heart rate at rest in (beats per minute)
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From baseline to 10 minutes after exercise training
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Pulse pressure measured by a blood pressure cuff
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Pulse pressure in the unit of (mmHg)
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From baseline to 10 minutes after exercise training
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Body mass measured by a scale
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Body mass in (kg)
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From baseline to 10 minutes after exercise training
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Body mass index calculated from weight plus height and elevated to square
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Body mass index in (kg/m2)
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From baseline to 10 minutes after exercise training
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Waist circumference measured by a flexible tape
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Waist circumference in (cm)
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From baseline to 10 minutes after exercise training
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Body fat percentage measured by a digital bioimpedanciometer scale
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Body fat percentage in (%)
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From baseline to 10 minutes after exercise training
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Lean mass measured by a digital bioimpedanciometer scale
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Body fat percentage in (kg)
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From baseline to 10 minutes after exercise training
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Skeletal muscle mass measured by a digital bioimpedanciometer scale
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Skeletal muscle mass in (kg)
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From baseline to 10 minutes after exercise training
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Bone mass measured by a digital bioimpedanciometer scale
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Bone mass in (kg)
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From baseline to 10 minutes after exercise training
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Basal metabolic rate measured by a digital bioimpedanciometer scale
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Basal metabolic rate in (Kcal)
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From baseline to 10 minutes after exercise training
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Fasting plasma glucose measured by blood sample in fasting state
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Fasting plasma glucose in (mg/dL)
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From baseline to 10 minutes after exercise training
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Total cholesterol measured by blood sample in fasting state
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Total cholesterol in (mg/dL)
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From baseline to 10 minutes after exercise training
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Low density lipids measured by blood sample in fasting state
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Low density lipids in (mg/dL)
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From baseline to 10 minutes after exercise training
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High density lipids measured by blood sample in fasting state
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in High density lipids in (mg/dL)
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From baseline to 10 minutes after exercise training
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Triglycerides measured by blood sample in fasting state
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Triglycerides in (mg/dL)
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From baseline to 10 minutes after exercise training
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Six minutes walking test measured by a walking test into a sport court
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Six minutes walking test in (m)
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From baseline to 10 minutes after exercise training
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Handgrip muscle strength of the non-dominant arm measured by a dynamometer hand equipment
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Handgrip strength in the non-dominant arm measured by dynamometer at sitting position in (kg)
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From baseline to 10 minutes after exercise training
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Handgrip strength Dominant arm measured by a dynamometer hand equipment
Time Frame: From baseline to 10 minutes after exercise training
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Change from Baseline in Handgrip strength in the Dominant arm measured by dynamometer at sitting position in (kg)
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From baseline to 10 minutes after exercise training
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Pedro Delgado Floody, PhD, Universidad de La Frontera
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Glucose Metabolism Disorders
- Metabolic Diseases
- Nervous System Diseases
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Insulin Resistance
- Hyperinsulinism
- Autonomic Nervous System Diseases
- Primary Dysautonomias
- Orthostatic Intolerance
- Obesity
- Metabolic Syndrome
- Obesity, Morbid
- Hypotension
- Post-Exercise Hypotension
Other Study ID Numbers
- UNAB-FCR-KINE2022A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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