Morbid ObesityNCT04932642
Nonresponders by the Session Order Factor
A study testing HIIT+RT experimental group and RT+HIIT experimental group in people with Morbid Obesity and Sports Physical Therapy, run by Cristian Alvarez at 1 site in Chile.
Trial summary
Concurrent training (CT, characterised by the inclusion of two exercise modalities), is recognised to improve metabolic syndrome (MetS) markers, but little is known about order session effect on interindividual variability. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Sports Physical Therapy
- What is being tested?
- HIIT+RT experimental group and RT+HIIT experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChile
- Study dates
- 1 Mar 2019to 6 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- being a candidate for bariatric surgery
- aged between 18 and 60 years
- tobe medically authorised
- with a body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2
- with additional comorbidities (i.e. diabetes, hypertension, insulin resistance) controlled by pharmacotherapy
Who cannot join
- having physical limitations preventing the performance of exercise (e.g. restricting injuries of the musculoskeletal system)
- having exercise-related dyspnoea or respiratory alterations
- having chronic heart disease with any worsening in the last month
- adhering to less than 80% of the total interventions (these results were excluded from the statistical analyses)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Two Different Orders of Concurrent Training on the Interindividual Variability of Health Markers of Metabolic Syndrome and Fitness in Severe/Morbidly Obesity Women. A Randomized Control Trial
Concurrent training (CT, characterised by the inclusion of two exercise modalities), is recognised to improve metabolic syndrome (MetS) markers, but little is known about order session effect on interindividual variability. The purpose of the present study was to describe the effects, and the interindividual variability, of 20 weeks of CT in different order at (i.e., high intensity interval training (HIIT) plus resistance training (RT), compared with another group doing RT plus HIIT) in women with severe/morbidly obesity at risk of MetS.
Read the detailed description
Morbid obesity, defined as a body mass index (BMI) of 40 kg/m2 (class III obesity), is a chronic disease with life-threatening cardiometabolic consequences such as elevated blood pressure (systolic [SBP] or diastolic BP [DBP]), fasting plasma glucose (FPG), triglycerides (Tg), and low high-density lipoprotein cholesterol (HDL-c), all summarised as metabolic syndrome (MetS). In this sense, exercise training as resistance training (RT), defined as any exercise that causes voluntary skeletal muscle contraction by using external weights such as dumbbells and metal bars, is a known non-pharmacotherapy strategy for improving muscle strength and functional capacity in obese patients undergoing bariatric surgery. Similarly, high-intensity interval training (HIIT), defined as several and brief bouts of high-intensity effort usually by cycling/running, interspersed by recovery periods ), has produced strong evidence for the improvement of cardiometabolic risk factors for type 2 diabetes mellitus, arterial hypertension, central arterial stiffness and, vascular function, and cardiorespiratory fitness. Thus, in individuals with morbid obesity, for example, exercise training has proven to be effective for inducing clinically significant weight loss (5-10%), and for the reduction of cardiovascular risk, following the standard recommendations for these cohorts prior to bariatric surgical. However, some inconsistencies have been described after CT, which are directly concerned with the 'order' (i.e. starting the CT session with MICT followed by RT, or vice versa) of the CT session. However, little is known about the interindividual variability of exercise training (IVET) in relation to different order sessions of CT in morbidly obese populations and health-related outcomes, such as MetS markers. Briefly, IVET means that some subjects achieve benefits after training, and are termed responders (Rs), while others exhibit a worsened or unchanged response, and that is commonly known termed as nonresponders (NRs).
- Conditions
- Morbid Obesity, Sports Physical Therapy
- Being tested
- HIIT+RT experimental group, RT+HIIT experimental group
- Keywords
- Morbid obesity, Exercise training, Metabolic syndrome, Concurrent training, Exercise order
- Medical subject headings
- Obesity, Morbid, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIIT+RT experimental groupBehavioural
Each experimental group will be compared with their another contrast order session group
RT+HIIT experimental groupBehavioural
Each experimental group will be compared with their another contrast order session group
| Study group | Role | What they receive |
|---|---|---|
| High-intensity interval training plus resistance training (HIIT+RT) | Experimental | The HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points. Second, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting 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 three 3 sets of as many repetitions as possible in 60 seconds, followed by 60 to 120 seconds of passive recovery. Receives: Behavioral: HIIT+RT experimental group |
| Resistance training plus High-intensity interval training (RT+HIIT) | Experimental | Firstly, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting 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 three 3 sets of 60 seconds, followed by 60 to 120 seconds of passive recovery, as previously reported. Secondly, in the HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points. Receives: Behavioral: RT+HIIT experimental group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Component of metabolic syndrome risk factors
Measured: Baseline to 20-weeks of concurrent training
Waist circumference
Component of metabolic syndrome risk factors
Measured: Baseline to 20-weeks of concurrent training
Systolic blood pressure
Component of metabolic syndrome risk factors
Measured: Component of metabolic syndrome risk factors
Diastolic blood pressure
Component of metabolic syndrome risk factors
Measured: Baseline to 20-weeks of concurrent training
High-density lipoprotein cholesterol
Component of metabolic syndrome risk factors
Measured: Baseline to 20-weeks of concurrent training
Triglycerides
Component of metabolic syndrome risk factors
Measured: Baseline to 20-weeks of concurrent training
Secondary outcomes (10)
Body mass (kg)
Anthropometry parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Measured: Baseline to 20-weeks of concurrent training
Body mass index (height/m2)
Anthropometry parameter related with health and intervention effects
Measured: Baseline to 20-weeks of concurrent training
Body fat percentage (%)
Anthropometry parameter related with health and intervention effects
Measured: Baseline to 20-weeks of concurrent training
Body fat (kilograms)
Anthropometry parameter related with health and intervention effects
Measured: Baseline to 20-weeks of concurrent training
Skeletal muscle mass (kg)
Body composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Measured: Baseline to 20-weeks of concurrent training
Lean mass (kg)
Body composition parameter related with health and intervention effects. This outcome will be measured by a bio-impedance scale (TANITATM, model 331, Tokyo, Japan).
Measured: Baseline to 20-weeks of concurrent training
Total cholesterol
Metabolic parameter related with health and intervention effects
Measured: Baseline to 20-weeks of concurrent training
Low-density lipoprotein cholesterol
Metabolic parameter related with health and intervention effects
Measured: Baseline to 20-weeks of concurrent training
Handgrip muscle strength (kg)
Physical fitness outcome related with health and intervention effects. This outcome will be measure using a digital dynamometer (BaselineTM Hydraulic Hand Dynamometers, USA),
Measured: Baseline to 20-weeks of concurrent training
Six minutes walking test
Physical fitness outcome related with health and intervention effects
Measured: Baseline to 20-weeks of concurrent training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start1 Mar 2019
- Primary completion31 Dec 2019
- Study completion6 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will compare a concurrent training group (HIIT+RT) with morbid obesity with another experimental group of concurrent training with morbid obesity, but with another exercise order (RT+HIIT).
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cristian Alvarez
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de La Frontera
- Responsible party
- Sponsor-investigator, Cristian Alvarez, Universidad de Los Lagos
- Investigators
- Cristian Alvarez, PhD, Study director, Universidad de Los Lagos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932642
- Sponsor's protocol ID
- RP08042020
- Status last verified
- Jun 2021
- First submitted
- 2 Jun 2021
- Last updated
- 21 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participant's information will be available by e-mail according to with researcher's requirements.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Two Different Orders of Concurrent Training on the Interindividual Variability of Health Markers of Metabolic Syndrome and Fitness in Severe/Morbidly Obesity Women. A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04932642
- Acronym / sponsor ID
- RP08042020
- Conditions
- Morbid Obesity, Sports Physical Therapy
- Keywords
- Morbid obesity, Exercise training, Metabolic syndrome, Concurrent training, Exercise order
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Cristian AlvarezUniversity, hospital or other
- Collaborators
- Universidad de La Frontera
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 6 Jul 2020 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Concurrent training (CT, characterised by the inclusion of two exercise modalities), is recognised to improve metabolic syndrome (MetS) markers, but little is known about order session effect on interindividual variability. The purpose of the present study was to describe the effects, and the interindividual variability, of 20 weeks of CT in different order at (i.e., high intensity interval training (HIIT) plus resistance training (RT), compared with another group doing RT plus HIIT) in women with severe/morbidly obesity at risk of MetS.
Detailed description
Morbid obesity, defined as a body mass index (BMI) of 40 kg/m2 (class III obesity), is a chronic disease with life-threatening cardiometabolic consequences such as elevated blood pressure (systolic [SBP] or diastolic BP [DBP]), fasting plasma glucose (FPG), triglycerides (Tg), and low high-density lipoprotein cholesterol (HDL-c), all summarised as metabolic syndrome (MetS). In this sense, exercise training as resistance training (RT), defined as any exercise that causes voluntary skeletal muscle contraction by using external weights such as dumbbells and metal bars, is a known non-pharmacotherapy strategy for improving muscle strength and functional capacity in obese patients undergoing bariatric surgery. Similarly, high-intensity interval training (HIIT), defined as several and brief bouts of high-intensity effort usually by cycling/running, interspersed by recovery periods ), has produced strong evidence for the improvement of cardiometabolic risk factors for type 2 diabetes mellitus, arterial hypertension, central arterial stiffness and, vascular function, and cardiorespiratory fitness. Thus, in individuals with morbid obesity, for example, exercise training has proven to be effective for inducing clinically significant weight loss (5-10%), and for the reduction of cardiovascular risk, following the standard recommendations for these cohorts prior to bariatric surgical. However, some inconsistencies have been described after CT, which are directly concerned with the 'order' (i.e. starting the CT session with MICT followed by RT, or vice versa) of the CT session. However, little is known about the interindividual variability of exercise training (IVET) in relation to different order sessions of CT in morbidly obese populations and health-related outcomes, such as MetS markers. Briefly, IVET means that some subjects achieve benefits after training, and are termed responders (Rs), while others exhibit a worsened or unchanged response, and that is commonly known termed as nonresponders (NRs).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- We will compare a concurrent training group (HIIT+RT) with morbid obesity with another experimental group of concurrent training with morbid obesity, but with another exercise order (RT+HIIT).
| Arm | Type | Receives |
|---|---|---|
| High-intensity interval training plus resistance training (HIIT+RT) | Experimental | Behavioral: HIIT+RT experimental groupThe HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points. Second, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting 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 three 3 sets of as many repetitions as possible in 60 seconds, followed by 60 to 120 seconds of passive recovery. |
| Resistance training plus High-intensity interval training (RT+HIIT) | Experimental | Behavioral: RT+HIIT experimental groupFirstly, in the RT section, three to out of four RT exercises were included (according to the planning week), targeting 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 three 3 sets of 60 seconds, followed by 60 to 120 seconds of passive recovery, as previously reported. Secondly, in the HIIT+RT group, the HIIT section consisted of 60 seconds of maximum intensity exercise using a magnetic resistance static bicycle (OxfordTM Fitness, model BE-2701, Chile), followed by 60-120 seconds of passive recovery over the bicycle totally off. This was repeated four to seven times according to the weekly schedule. The intensity of the exercise was measured on the Borg scale of 1 to 10 of perceived exertion and the participants worked at a level of between 6 to 9 points. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- being a candidate for bariatric surgery
- aged between 18 and 60 years
- tobe medically authorised
- with a body mass index (BMI) ≥40 kg/m2 or ≥35 kg/m2
- with additional comorbidities (i.e. diabetes, hypertension, insulin resistance) controlled by pharmacotherapy
Key exclusion criteria (4 listed)
- having physical limitations preventing the performance of exercise (e.g. restricting injuries of the musculoskeletal system)
- having exercise-related dyspnoea or respiratory alterations
- having chronic heart disease with any worsening in the last month
- adhering to less than 80% of the total interventions (these results were excluded from the statistical analyses)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIIT+RT experimental groupEach experimental group will be compared with their another contrast order session group | Behavioural | High-intensity interval training plus resistance training (HIIT+RT) |
| RT+HIIT experimental groupEach experimental group will be compared with their another contrast order session group | Behavioural | Resistance training plus High-intensity interval training (RT+HIIT) |
Primary outcome
Fasting glucose
Time frame: Baseline to 20-weeks of concurrent training
Component of metabolic syndrome risk factors
Waist circumference
Time frame: Baseline to 20-weeks of concurrent training
Component of metabolic syndrome risk factors
Systolic blood pressure
Time frame: Component of metabolic syndrome risk factors
Component of metabolic syndrome risk factors
Diastolic blood pressure
Time frame: Baseline to 20-weeks of concurrent training
Component of metabolic syndrome risk factors
High-density lipoprotein cholesterol
Time frame: Baseline to 20-weeks of concurrent training
Component of metabolic syndrome risk factors
Triglycerides
Time frame: Baseline to 20-weeks of concurrent training
Component of metabolic syndrome risk factors
10 secondary outcomes
Body mass (kg)
Time frame: Baseline to 20-weeks of concurrent training
Body mass index (height/m2)
Time frame: Baseline to 20-weeks of concurrent training
Body fat percentage (%)
Time frame: Baseline to 20-weeks of concurrent training
Body fat (kilograms)
Time frame: Baseline to 20-weeks of concurrent training
Skeletal muscle mass (kg)
Time frame: Baseline to 20-weeks of concurrent training
Lean mass (kg)
Time frame: Baseline to 20-weeks of concurrent training
Total cholesterol
Time frame: Baseline to 20-weeks of concurrent training
Low-density lipoprotein cholesterol
Time frame: Baseline to 20-weeks of concurrent training
Handgrip muscle strength (kg)
Time frame: Baseline to 20-weeks of concurrent training
Six minutes walking test
Time frame: Baseline to 20-weeks of concurrent training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2021.
- Individual participant dataSharing planned: No. The participant's information will be available by e-mail according to with researcher's requirements.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cristian Alvarez, PhD study director
Universidad de Los Lagos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HIIT+RT experimental group and RT+HIIT experimental group in people with Morbid Obesity and Sports Physical Therapy, run by Cristian Alvarez at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting glucose (time frame: Baseline to 20-weeks of concurrent training). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2021.