Sedentary BehaviorBREAK001NCT03949205
Sedentary Behavior Breaks With Isometric Exercise in Cardiovascular Health Indicators
A study testing Leg Extension Isometric Training in people with Sedentary Behavior, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
The goal of this study is to analyze the chronic effects of sedentary behavior breaks using the leg extension isometric exercise in the cardiovascular health indicators of healthy adults exposed to prolonged time in the sitting position. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior
- What is being tested?
- Leg Extension Isometric Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteBrazil
- Study dates
- 13 May 2019to 20 Feb 2021
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No diagnostic of cardiovascular diseases or diabetes
- Do not present high cardiovascular risk
- Do not participate in an exercise program in the previous six months
- Occupational activity that requires more than six hours of sitting time per day
- Do not be a smoker or make use of medications
Who cannot join
- Adherence to the training sessions inferior to 85%
- Adherence to another supervised exercise program
- Change the characteristics of the occupational activities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Breaks of Sedentary Behavior With Isometric Exercise in Cardiovascular Health Indicators of Adults
The goal of this study is to analyze the chronic effects of sedentary behavior breaks using the leg extension isometric exercise in the cardiovascular health indicators of healthy adults exposed to prolonged time in the sitting position. The patients recruited will be randomized into two groups: leg extension isometric training (TIE) and control group (CG). The TIE group will perform 12 weeks of isometric training. The CG will be advised not to change their routine activities, especially diet and physical activities.In the pre and post-intervention periods cardiovascular measures will be obtained.
Read the detailed description
Long periods in sedentary behavior promote deterioration of vascular function, which is directly associated with the occurence of chronic noncommunicable diseases. In this context, the execution of interruptions in this behavior (breaks) is recommended. Studies have shown benefits of isometric training in vascular function, which could be useful to minimize the consequences of time spent in sedentary behavior. Thus, the goal of this study is to analyze the chronic effects of sedentary behavior breaks using leg extension isometric exercise in the cardiovascular health indicators of adults exposed to prolonged time in the sitting position. The target population of the study will consist of healthy subjects above 18 years of age of both genders. All subjects will be submitted to measurements of endothelial function, blood pressure and cardiac autonomic modulation. After these measurements, the subjects will be randomized into two groups: leg extension isometric training group (TIE) and control group (CG). After 12 weeks both groups will be submitted to the same measurements from pre-intervention.
- Conditions
- Sedentary Behavior
- Being tested
- Leg Extension Isometric Training
- Medical subject headings
- Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leg Extension Isometric TrainingOther
The leg extension isometric exercise will be performed tree times a week , in four 2 min bouts of isometric contraction, at a intensity of 30% of maximal voluntary contraction and an interval of two minutes between bouts.
| Study group | Role | What they receive |
|---|---|---|
| Leg Extension Isometric Training | Experimental | Experimental group will perform leg extension isometric exercise. Receives: Other: Leg Extension Isometric Training |
| Control Group | No intervention | Control group will be advised to maintain their work habits and not to change their routine activities, especially diet and physical activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in vascular function at 12 weeks
Vascular function will be measured before and after 12 weeks of intervention on the intervention and control groups by a bidimensional ultrasonography device with spectral Doppler and linear transducer.
Measured: Baseline and 12 weeks
Secondary outcomes (2)
Changes from baseline in blood pressure at 12 weeks
Blood pressure will be measured before and after 12 weeks of intervention period on intervention and control group by an automatic blood pressure monitor (HEM-742, Omron Healthcare, Japan).
Measured: Baseline and 12 weeks
Change from baseline in cardiac autonomic modulation at 12 weeks
Cardiac autonomic modulation will be measured before and after 12 weeks of intervention period on intervention and control group by heart rate monitor (Polar V800, Polar Electro, Finland).
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start13 May 2019
- Primary completion30 Dec 2020
- Study completion20 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial and randomized crossover trial.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raphael Mendes Ritti Dias, University of Nove de Julho
- Investigators
- Raphael Ritti-Dias, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03949205
- Sponsor's protocol ID
- BREAK001
- Acronym
- BREAK001
- Status last verified
- Sep 2021
- First submitted
- 10 May 2019
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the data upon requirement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Breaks of Sedentary Behavior With Isometric Exercise in Cardiovascular Health Indicators of Adults
- ClinicalTrials.gov ID
- NCT03949205
- Acronym / sponsor ID
- BREAK001 / BREAK001
- Conditions
- Sedentary Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 13 May 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 20 Feb 2021 (actual)
- First posted
- 14 May 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 goal of this study is to analyze the chronic effects of sedentary behavior breaks using the leg extension isometric exercise in the cardiovascular health indicators of healthy adults exposed to prolonged time in the sitting position. The patients recruited will be randomized into two groups: leg extension isometric training (TIE) and control group (CG). The TIE group will perform 12 weeks of isometric training. The CG will be advised not to change their routine activities, especially diet and physical activities.In the pre and post-intervention periods cardiovascular measures will be obtained.
Detailed description
Long periods in sedentary behavior promote deterioration of vascular function, which is directly associated with the occurence of chronic noncommunicable diseases. In this context, the execution of interruptions in this behavior (breaks) is recommended. Studies have shown benefits of isometric training in vascular function, which could be useful to minimize the consequences of time spent in sedentary behavior. Thus, the goal of this study is to analyze the chronic effects of sedentary behavior breaks using leg extension isometric exercise in the cardiovascular health indicators of adults exposed to prolonged time in the sitting position. The target population of the study will consist of healthy subjects above 18 years of age of both genders. All subjects will be submitted to measurements of endothelial function, blood pressure and cardiac autonomic modulation. After these measurements, the subjects will be randomized into two groups: leg extension isometric training group (TIE) and control group (CG). After 12 weeks both groups will be submitted to the same measurements from pre-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial and randomized crossover trial.
| Arm | Type | Receives |
|---|---|---|
| Leg Extension Isometric Training | Experimental | Other: Leg Extension Isometric TrainingExperimental group will perform leg extension isometric exercise. |
| Control Group | No intervention | –Control group will be advised to maintain their work habits and not to change their routine activities, especially diet and physical activities. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- No diagnostic of cardiovascular diseases or diabetes
- Do not present high cardiovascular risk
- Do not participate in an exercise program in the previous six months
- Occupational activity that requires more than six hours of sitting time per day
- Do not be a smoker or make use of medications
Key exclusion criteria (3 listed)
- Adherence to the training sessions inferior to 85%
- Adherence to another supervised exercise program
- Change the characteristics of the occupational activities
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 |
|---|---|---|
| Leg Extension Isometric TrainingThe leg extension isometric exercise will be performed tree times a week , in four 2 min bouts of isometric contraction, at a intensity of 30% of maximal voluntary contraction and an interval of two minutes between bouts. | Other | Leg Extension Isometric Training |
Primary outcome
Change from baseline in vascular function at 12 weeks
Time frame: Baseline and 12 weeks
Vascular function will be measured before and after 12 weeks of intervention on the intervention and control groups by a bidimensional ultrasonography device with spectral Doppler and linear transducer.
2 secondary outcomes
Changes from baseline in blood pressure at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline in cardiac autonomic modulation at 12 weeks
Time frame: Baseline and 12 weeks
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 29 Sep 2021.
- Individual participant dataSharing planned: Yes. We plan to share the data upon requirement.
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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.
Raphael Ritti-Dias, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leg Extension Isometric Training in people with Sedentary Behavior, run by University of Nove de Julho 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 5 inclusion and 3 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 29 Sep 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 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?
Change from baseline in vascular function at 12 weeks (time frame: Baseline and 12 weeks). 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 29 Sep 2021.