Metabolic SyndromeNCT03119493
Periodized Aerobic Interval Training in Metabolic Syndrome
A study testing Periodized aerobic interval training in people with Metabolic Syndrome and Metabolic Syndrome X, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
Autonomic disfunction present in metabolic syndrome subjects is related by a greater vulnerability of the heart and risk of cardiovascular events. In this context, aerobic interval training has been highlighted by its easy applicability and benefits effects in autonomic modulation in different populations. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Metabolic Syndrome, Metabolic Syndrome X
- What is being tested?
- Periodized aerobic interval training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jun 2015to 1 Dec 2016
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Metabolic syndrome according to international diabetes federation (IDF) definition
- Aged between 40 to 60 years
Who cannot join
- Participants who are currently participating in any regular exercise programs last six months;
- Use of drugs or medication (Except for risk factors of metabolic syndrome control);
- Inflammatory or infectious process;
- Musculotendinous or osteoarticular injuries in the lower limbs and/or spine;
- Chronic pulmonary disease;
- Neurological disorders;
- Cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Periodized Aerobic Interval Training on Autonomic Modulation and Cardiovascular and Anthropometric Variables in Individuals With Metabolic Syndrome
Autonomic disfunction present in metabolic syndrome subjects is related by a greater vulnerability of the heart and risk of cardiovascular events. In this context, aerobic interval training has been highlighted by its easy applicability and benefits effects in autonomic modulation in different populations. Therefore the studies that use de aerobic interval training in this different populations didn't realize a periodization of training with preparatory periods with progressive increase of load, specific phases with less duration predominating the intensity and transition periods for recuperation. Additionally, there isn't studies that investigate the effects of aerobic interval training in autonomic modulation of individuals with metabolic syndrome. In this context, periodized aerobic interval training can arise like a new type of treatment that offering security and efficacy in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and anthropometric parameters of individuals with metabolic syndrome.
- Conditions
- Metabolic Syndrome, Metabolic Syndrome X
- Being tested
- Periodized aerobic interval training
- Keywords
- Metabolic syndrome X, Autonomic nervous system, Aerobic exercise, Exercise, Heart rate
- Medical subject headings
- Metabolic Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodized aerobic interval trainingBehavioural
The periodized training program consist in 3 phases: light (I) (training range varying between 20 to 39% of heart rate reserve and active recuperation of 19% of heart rate reserve); moderate (II) (training range varying between 40 to 59% of heart rate reserve and active recuperation of 30% of heart rate reserve) and high (III) (training range varying between 70 to 90 % of heart rate reserve and active recuperation of 50% of heart rate reserve).
| Study group | Role | What they receive |
|---|---|---|
| Periodized aerobic interval training | Experimental | The experimental groups will participate in a 16 week, three times a week based-program of periodized aerobic interval training that consist in warming [5 minutes of general stretching and 5 minutes of walking on treadmill with heart rate less than 20 percent of heart rate reserve (HHR)], followed by periodized aerobic interval training on treadmill, and cooling down [5 minutes of walk in treadmill with a heart rate less than 20 percent of HRR and 5 minutes of rest] Receives: Behavioral: Periodized aerobic interval training |
| Control group | No intervention | Participants in the control group will be instructed not to take part in any regular exercise programs during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability
Measured: 16 week after allocation
Secondary outcomes (5)
Cardiovascular parameter : heart rate
Measured: 16 week after allocation
Cardiovascular parameter: blood pressure
Measured: 16 week after allocation
Anthropometric parameter: hit waist ratio
Measured: 16 week after allocation
Anthropometric parameter: abdominal circumference
Measured: 16 week after allocation
Anthropometric parameter: body mass index
Measured by weight and height
Measured: 16 week after allocation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start1 Jun 2015
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
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 Metabolic SyndromeStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laís M. Vanzella, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos M Vanderlei, PHD, Study director, Universidade Estadual Paulista - UNESP campus de Presidente Prudente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119493
- Sponsor's protocol ID
- 53117116000005402
- Status last verified
- Apr 2017
- First submitted
- 7 Apr 2017
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: I don't have plans
Publications
Vanzella LM, Linares SN, Miranda RAT, Silva AKFD, Christofaro DGD, Netto Junior J, Vanderlei LCM. Effects of a new approach of aerobic interval training on cardiac autonomic modulation and cardiovascular parameters of metabolic syndrome subjects. Arch Endocrinol Metab. 2019 Mar-Apr;63(2):148-156. doi: 10.20945/2359-3997000000111. Epub 2019 Mar 21.
PubMed 30916161
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Periodized Aerobic Interval Training on Autonomic Modulation and Cardiovascular and Anthropometric Variables in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT03119493
- Acronym / sponsor ID
- 53117116000005402
- Conditions
- Metabolic Syndrome, Metabolic Syndrome X
- Keywords
- Metabolic syndrome X, Autonomic nervous system, Aerobic exercise, Exercise, Heart rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 1 Jun 2015 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 18 Apr 2017 (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.
Autonomic disfunction present in metabolic syndrome subjects is related by a greater vulnerability of the heart and risk of cardiovascular events. In this context, aerobic interval training has been highlighted by its easy applicability and benefits effects in autonomic modulation in different populations. Therefore the studies that use de aerobic interval training in this different populations didn't realize a periodization of training with preparatory periods with progressive increase of load, specific phases with less duration predominating the intensity and transition periods for recuperation. Additionally, there isn't studies that investigate the effects of aerobic interval training in autonomic modulation of individuals with metabolic syndrome. In this context, periodized aerobic interval training can arise like a new type of treatment that offering security and efficacy in subjects with metabolic syndrome. So, the aim of the study is evaluate the effect of periodized aerobic interval training in cardiac autonomic modulation and cardiovascular and anthropometric parameters of individuals with metabolic syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Periodized aerobic interval training | Experimental | Behavioral: Periodized aerobic interval trainingThe experimental groups will participate in a 16 week, three times a week based-program of periodized aerobic interval training that consist in warming [5 minutes of general stretching and 5 minutes of walking on treadmill with heart rate less than 20 percent of heart rate reserve (HHR)], followed by periodized aerobic interval training on treadmill, and cooling down [5 minutes of walk in treadmill with a heart rate less than 20 percent of HRR and 5 minutes of rest] |
| Control group | No intervention | –Participants in the control group will be instructed not to take part in any regular exercise programs during the study period. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Metabolic syndrome according to international diabetes federation (IDF) definition
- Aged between 40 to 60 years
Key exclusion criteria (7 listed)
- Participants who are currently participating in any regular exercise programs last six months;
- Use of drugs or medication (Except for risk factors of metabolic syndrome control);
- Inflammatory or infectious process;
- Musculotendinous or osteoarticular injuries in the lower limbs and/or spine;
- Chronic pulmonary disease;
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 |
|---|---|---|
| Periodized aerobic interval trainingThe periodized training program consist in 3 phases: light (I) (training range varying between 20 to 39% of heart rate reserve and active recuperation of 19% of heart rate reserve); moderate (II) (training range varying between 40 to 59% of heart rate reserve and active recuperation of 30% of heart rate reserve) and high (III) (training range varying between 70 to 90 % of heart rate reserve and active recuperation of 50% of heart rate reserve). | Behavioural | Periodized aerobic interval training |
Primary outcome
Heart rate variability
Time frame: 16 week after allocation
5 secondary outcomes
Cardiovascular parameter : heart rate
Time frame: 16 week after allocation
Cardiovascular parameter: blood pressure
Time frame: 16 week after allocation
Anthropometric parameter: hit waist ratio
Time frame: 16 week after allocation
Anthropometric parameter: abdominal circumference
Time frame: 16 week after allocation
Anthropometric parameter: body mass index
Time frame: 16 week after allocation
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 18 Apr 2017.
- Derived from this study: PubMed 30916161Vanzella LM, Linares SN, Miranda RAT, Silva AKFD, Christofaro DGD, Netto Junior J, Vanderlei LCM. Effects of a new approach of aerobic interval training on cardiac autonomic modulation and cardiovascular parameters of metabolic syndrome subjects. Arch Endocrinol Metab. 2019 Mar-Apr;63(2):148-156. doi: 10.20945/2359-3997000000111. Epub 2019 Mar 21.
- Individual participant dataSharing planned: No. I don't have plans
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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.
Luiz Carlos M Vanderlei, PHD study director
Universidade Estadual Paulista - UNESP campus de Presidente Prudente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Periodized aerobic interval training in people with Metabolic Syndrome and Metabolic Syndrome X, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
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 2 inclusion and 7 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 18 Apr 2017. 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 Brazil. 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?
Heart rate variability (time frame: 16 week after allocation). 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 NCT03119493, 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 18 Apr 2017.