Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05504629
Other study ID # UNAB-FCR-KINE2022A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT04635202 - Effect of Elliptical Training on Metabolic Homeostasis in Metabolic Syndrome N/A
Completed NCT05343858 - Pilot Study to Evaluate the Effect of Two Microalgae Consumption on Metabolic Syndrome N/A
Completed NCT04053686 - An Intervention to Reduce Prolonged Sitting in Police Staff N/A
Active, not recruiting NCT05891834 - Study of INV-202 in Patients With Obesity and Metabolic Syndrome Phase 2
Recruiting NCT05040958 - Carotid Atherosclerotic Plaque Load and Neck Circumference
Completed NCT03644524 - Heat Therapy and Cardiometabolic Health in Obese Women N/A
Active, not recruiting NCT02500147 - Metformin for Ectopic Fat Deposition and Metabolic Markers in Polycystic Ovary Syndrome (PCOS) Phase 4
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT05972564 - The Effect of SGLT2 Inhibition on Adipose Inflammation and Endothelial Function Phase 1/Phase 2
Completed NCT03289897 - Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan N/A
Recruiting NCT05956886 - Sleep Chatbot Intervention for Emerging Black/African American Adults N/A
Completed NCT06057896 - Effects of Combined Natural Molecules on Metabolic Syndrome in Menopausal Women
Active, not recruiting NCT03613740 - Effect of Fucoxanthin on the Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion Phase 2
Completed NCT04498455 - Study of a Prebiotic Supplement to Mitigate Excessive Weight Gain Among Physicians in Residency Phase 4
Completed NCT05688917 - Green Coffee Effect on Metabolic Syndrome N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT03697382 - Effect of Daily Steps on Fat Metabolism N/A
Completed NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Completed NCT04509206 - Virtual Teaching Kitchen N/A
Completed NCT05124847 - TREating Pediatric Obesity N/A