Morbid ObesityExinMONCT03921853
Resistance Training in Patients With Morbid Obesity
A study testing Behavioral in people with Morbid Obesity and Obesity, run by Universidad de Los Lagos at 1 site in Chile.
Trial summary
The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Morbid Obesity, Obesity, Physical Activity
- What is being tested?
- Behavioral
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChile
- Study dates
- 1 Jan 2018to 30 Apr 2018
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 and younger and ≤65 years of age.
- With risk factors to Metabolic syndrome
- With obesity and morbid obesity condition
- Medical authorization by a physician.
Who cannot join
- Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
- Exercise-related dyspnoea or respiratory alterations.
- Chronic heart disease with any worsening in the last month.
- Adherence rate of less than 80% of the total interventions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence
The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.
Read the detailed description
The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.
Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.
- Conditions
- Morbid Obesity, Obesity, Physical Activity, Metabolic Syndrome, Risk Factor, Cardiovascular
- Being tested
- Behavioral
- Medical subject headings
- Obesity, Morbid, Obesity, Motor Activity, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BehavioralOther
Also called Resistant training intervention
The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group. All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries. Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors. The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery. Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
| Study group | Role | What they receive |
|---|---|---|
| Active comparator | Active comparator | Control group with obesity under Resistant Training Receives: Other: Behavioral |
| Experimental group with morbid obesity | Experimental | Experimental group with morbid obesity under Resistant Training Receives: Other: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting glucose
Component of the Metabolic Syndrome
Measured: Change from Baseline Fasting glucose at 20-weeks of Resistant Training
High density lipoprotein
Component of the Metabolic Syndrome
Measured: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
Systolic blood pressure and diastolic blood pressure
Component of the Metabolic Syndrome
Measured: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
Waist circumference
Component of the Metabolic Syndrome
Measured: Change from Baseline Waist circumference at 20-weeks of Resistant Training
Triglycerides
Component of the Metabolic Syndrome
Measured: Change from Baseline Triglycerides at 20-weeks of Resistant Training
Secondary outcomes (7)
Body mass index
Anthropometric
Measured: Change from Baseline Body mass index at 20-weeks of Resistant Training
Body mass
Anthropometric
Measured: Change from Baseline Body mass at 20-weeks of Resistant Training
Total cholesterol
Measured by plasma sample
Measured: Change from Baseline Total cholesterol at 20-weeks of Resistant Training
Low density lipoprotein
Measured by plasma sample
Measured: Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
Six minutes walking test
Endurance performance
Measured: Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
One maximum repetition of biceps curl
Strength Performance
Measured: Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
Handgrip muscle strength
Muscle strength
Measured: Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Jan 2018
- Primary completion4 Apr 2018
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We will compare a control group with obesity with another experimental group with morbid obesity in the metabolic syndrome parameters.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Los Lagos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad de La Frontera
- Responsible party
- Sponsor
- Investigators
- Cristian ALvarez, PhD, Study director, Universidad de Los Lagos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921853
- Sponsor's protocol ID
- RP08042019
- Acronym
- ExinMO
- Status last verified
- Apr 2019
- First submitted
- 8 Apr 2019
- Last updated
- 19 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participants information will be available by e-mail according with researchers requirements.
Publications
Delgado-Floody P, Alvarez C, Lusa Cadore E, Flores-Opazo M, Caamano-Navarrete F, Izquierdo M. Preventing metabolic syndrome in morbid obesity with resistance training: Reporting interindividual variability. Nutr Metab Cardiovasc Dis. 2019 Dec;29(12):1368-1381. doi: 10.1016/j.numecd.2019.07.002. Epub 2019 Jul 12.
PubMed 31383503
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence
- ClinicalTrials.gov ID
- NCT03921853
- Acronym / sponsor ID
- ExinMO / RP08042019
- Conditions
- Morbid Obesity, Obesity, Physical Activity, Metabolic Syndrome, Risk Factor, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Universidad de Los LagosUniversity, hospital or other
- Collaborators
- Universidad de La Frontera
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 4 Apr 2018 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 19 Apr 2019 (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.
The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.
Detailed description
The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state.
Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- We will compare a control group with obesity with another experimental group with morbid obesity in the metabolic syndrome parameters.
| Arm | Type | Receives |
|---|---|---|
| Active comparator | Active comparator | Other: BehavioralControl group with obesity under Resistant Training |
| Experimental group with morbid obesity | Experimental | Other: BehavioralExperimental group with morbid obesity under Resistant Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Older than 18 and younger and ≤65 years of age.
- With risk factors to Metabolic syndrome
- With obesity and morbid obesity condition
- Medical authorization by a physician.
Key exclusion criteria (4 listed)
- Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
- Exercise-related dyspnoea or respiratory alterations.
- Chronic heart disease with any worsening in the last month.
- Adherence rate of less than 80% of the total interventions.
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 |
|---|---|---|
| BehavioralAlso: Resistant training interventionThe 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group. All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries. Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors. The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery. Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise. | Other | Active comparator, Experimental group with morbid obesity |
Primary outcome
Fasting glucose
Time frame: Change from Baseline Fasting glucose at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
High density lipoprotein
Time frame: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
Systolic blood pressure and diastolic blood pressure
Time frame: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
Component of the Metabolic Syndrome
Waist circumference
Time frame: Change from Baseline Waist circumference at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
Triglycerides
Time frame: Change from Baseline Triglycerides at 20-weeks of Resistant Training
Component of the Metabolic Syndrome
7 secondary outcomes
Body mass index
Time frame: Change from Baseline Body mass index at 20-weeks of Resistant Training
Body mass
Time frame: Change from Baseline Body mass at 20-weeks of Resistant Training
Total cholesterol
Time frame: Change from Baseline Total cholesterol at 20-weeks of Resistant Training
Low density lipoprotein
Time frame: Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
Six minutes walking test
Time frame: Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
One maximum repetition of biceps curl
Time frame: Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
Handgrip muscle strength
Time frame: Change from Baseline Handgrip muscle strength at 20-weeks of Resistant 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 19 Apr 2019.
- Derived from this study: PubMed 31383503Delgado-Floody P, Alvarez C, Lusa Cadore E, Flores-Opazo M, Caamano-Navarrete F, Izquierdo M. Preventing metabolic syndrome in morbid obesity with resistance training: Reporting interindividual variability. Nutr Metab Cardiovasc Dis. 2019 Dec;29(12):1368-1381. doi: 10.1016/j.numecd.2019.07.002. Epub 2019 Jul 12.
- Individual participant dataSharing planned: No. The participants information will be available by e-mail according with researchers 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 Behavioral in people with Morbid Obesity and Obesity, run by Universidad de Los Lagos 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 4 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 19 Apr 2019. 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: Change from Baseline Fasting glucose at 20-weeks of Resistant Training). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921853, which also lists 1 linked publication.
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 19 Apr 2019; AzTrials last refreshed its copy on 7 Nov 2026.