Interindividual Postexercise Hypotension Response in Morbid Obesity
Primary Purpose
Metabolic Syndrome, Morbid Obesity
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Concurrent training order 1
RT+ET
Sponsored by
About this trial
This is an interventional treatment trial for Metabolic Syndrome
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
Sites / Locations
- Universidad de La Frontera
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Endurance Training (ET) plus Resistance Training (RT)
Resistance Training (RT) plus Endurance Training (ET)
Arm Description
Concurrent training of Endurance Training plus Resistance Training order.
Concurrent training of Resistance Training plus Endurance Training order.
Outcomes
Primary Outcome Measures
Systolic blood pressure measured by a blood pressure cuff
Change from Baseline in systolic blood pressure in the unit of (mmHg)
Diastolic blood pressure measured by a blood pressure cuff
Change from Baseline in diastolic blood pressure in the unit of (mmHg)
Mean arterial pressure measured by a blood pressure cuff
Change from Baseline in mean arterial blood pressure in the unit of (mmHg)
Secondary Outcome Measures
Heart rate at rest measured by a cardiometer watch
Change from Baseline in Heart rate at rest in (beats per minute)
Pulse pressure measured by a blood pressure cuff
Change from Baseline in Pulse pressure in the unit of (mmHg)
Body mass measured by a scale
Change from Baseline in Body mass in (kg)
Body mass index calculated from weight plus height and elevated to square
Change from Baseline in Body mass index in (kg/m2)
Waist circumference measured by a flexible tape
Change from Baseline in Waist circumference in (cm)
Body fat percentage measured by a digital bioimpedanciometer scale
Change from Baseline in Body fat percentage in (%)
Lean mass measured by a digital bioimpedanciometer scale
Change from Baseline in Body fat percentage in (kg)
Skeletal muscle mass measured by a digital bioimpedanciometer scale
Change from Baseline in Skeletal muscle mass in (kg)
Bone mass measured by a digital bioimpedanciometer scale
Change from Baseline in Bone mass in (kg)
Basal metabolic rate measured by a digital bioimpedanciometer scale
Change from Baseline in Basal metabolic rate in (Kcal)
Fasting plasma glucose measured by blood sample in fasting state
Change from Baseline in Fasting plasma glucose in (mg/dL)
Total cholesterol measured by blood sample in fasting state
Change from Baseline in Total cholesterol in (mg/dL)
Low density lipids measured by blood sample in fasting state
Change from Baseline in Low density lipids in (mg/dL)
High density lipids measured by blood sample in fasting state
Change from Baseline in High density lipids in (mg/dL)
Triglycerides measured by blood sample in fasting state
Change from Baseline in Triglycerides in (mg/dL)
Six minutes walking test measured by a walking test into a sport court
Change from Baseline in Six minutes walking test in (m)
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)
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)
Full Information
NCT ID
NCT05504629
First Posted
August 13, 2022
Last Updated
August 19, 2022
Sponsor
Universidad Nacional Andres Bello
Collaborators
Universidad de La Frontera
1. Study Identification
Unique Protocol Identification Number
NCT05504629
Brief Title
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
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
March 5, 2019 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
October 5, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Nacional Andres Bello
Collaborators
Universidad de La Frontera
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Morbid Obesity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Endurance Training (ET) plus Resistance Training (RT)
Arm Type
Experimental
Arm Description
Concurrent training of Endurance Training plus Resistance Training order.
Arm Title
Resistance Training (RT) plus Endurance Training (ET)
Arm Type
Active Comparator
Arm Description
Concurrent training of Resistance Training plus Endurance Training order.
Intervention Type
Behavioral
Intervention Name(s)
Concurrent training order 1
Other Intervention Name(s)
Exercise training
Intervention Description
atag
Intervention Type
Behavioral
Intervention Name(s)
RT+ET
Other Intervention Name(s)
Concurrent training order 2
Intervention Description
aetaer
Primary Outcome Measure Information:
Title
Systolic blood pressure measured by a blood pressure cuff
Description
Change from Baseline in systolic blood pressure in the unit of (mmHg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Diastolic blood pressure measured by a blood pressure cuff
Description
Change from Baseline in diastolic blood pressure in the unit of (mmHg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Mean arterial pressure measured by a blood pressure cuff
Description
Change from Baseline in mean arterial blood pressure in the unit of (mmHg)
Time Frame
From baseline to 10 minutes after exercise training
Secondary Outcome Measure Information:
Title
Heart rate at rest measured by a cardiometer watch
Description
Change from Baseline in Heart rate at rest in (beats per minute)
Time Frame
From baseline to 10 minutes after exercise training
Title
Pulse pressure measured by a blood pressure cuff
Description
Change from Baseline in Pulse pressure in the unit of (mmHg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Body mass measured by a scale
Description
Change from Baseline in Body mass in (kg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Body mass index calculated from weight plus height and elevated to square
Description
Change from Baseline in Body mass index in (kg/m2)
Time Frame
From baseline to 10 minutes after exercise training
Title
Waist circumference measured by a flexible tape
Description
Change from Baseline in Waist circumference in (cm)
Time Frame
From baseline to 10 minutes after exercise training
Title
Body fat percentage measured by a digital bioimpedanciometer scale
Description
Change from Baseline in Body fat percentage in (%)
Time Frame
From baseline to 10 minutes after exercise training
Title
Lean mass measured by a digital bioimpedanciometer scale
Description
Change from Baseline in Body fat percentage in (kg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Skeletal muscle mass measured by a digital bioimpedanciometer scale
Description
Change from Baseline in Skeletal muscle mass in (kg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Bone mass measured by a digital bioimpedanciometer scale
Description
Change from Baseline in Bone mass in (kg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Basal metabolic rate measured by a digital bioimpedanciometer scale
Description
Change from Baseline in Basal metabolic rate in (Kcal)
Time Frame
From baseline to 10 minutes after exercise training
Title
Fasting plasma glucose measured by blood sample in fasting state
Description
Change from Baseline in Fasting plasma glucose in (mg/dL)
Time Frame
From baseline to 10 minutes after exercise training
Title
Total cholesterol measured by blood sample in fasting state
Description
Change from Baseline in Total cholesterol in (mg/dL)
Time Frame
From baseline to 10 minutes after exercise training
Title
Low density lipids measured by blood sample in fasting state
Description
Change from Baseline in Low density lipids in (mg/dL)
Time Frame
From baseline to 10 minutes after exercise training
Title
High density lipids measured by blood sample in fasting state
Description
Change from Baseline in High density lipids in (mg/dL)
Time Frame
From baseline to 10 minutes after exercise training
Title
Triglycerides measured by blood sample in fasting state
Description
Change from Baseline in Triglycerides in (mg/dL)
Time Frame
From baseline to 10 minutes after exercise training
Title
Six minutes walking test measured by a walking test into a sport court
Description
Change from Baseline in Six minutes walking test in (m)
Time Frame
From baseline to 10 minutes after exercise training
Title
Handgrip muscle strength of the non-dominant arm measured by a dynamometer hand equipment
Description
Change from Baseline in Handgrip strength in the non-dominant arm measured by dynamometer at sitting position in (kg)
Time Frame
From baseline to 10 minutes after exercise training
Title
Handgrip strength Dominant arm measured by a dynamometer hand equipment
Description
Change from Baseline in Handgrip strength in the Dominant arm measured by dynamometer at sitting position in (kg)
Time Frame
From baseline to 10 minutes after exercise training
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro Delgado Floody, PhD
Organizational Affiliation
Universidad de La Frontera
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad de La Frontera
City
Temuco
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33192554
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.
Results Reference
result
PubMed Identifier
34621181
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.
Results Reference
result
PubMed Identifier
28153946
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.
Results Reference
result
Learn more about this trial
Interindividual Postexercise Hypotension Response in Morbid Obesity
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