AtherosclerosisNCT03352063
Prolonged Sitting on Responses to Short-Term Exercise Training
A study testing Prolonged sitting with exercise and Active walking with exercise. in people with Atherosclerosis and Metabolic Syndrome, run by University of Texas at Austin at 1 site in United States.
Trial summary
Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of prolonged sitting on response to a HFTT after a short term training period. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Metabolic Syndrome
- What is being tested?
- Prolonged sitting with exercise and Active walking with exercise.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jul 2018to 30 May 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 35 years
Who cannot join
- cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
- respiratory problems
- musculoskeletal problems that prevent prolonged sitting or exercise
- obesity
- susceptibility to fainting
- pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin Human Performance Laboratory
Austin, Texas, 78712
About this study
Official title: Effect of Prolonged Sitting on Metabolic and Cardiovascular Responses to Short-Term Exercise Training
Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of prolonged sitting on response to a HFTT after a short term training period.
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Being tested
- Prolonged sitting with exercise, Active walking with exercise.
- Medical subject headings
- Atherosclerosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged sitting with exerciseBehavioural
Subjects will commit to sitting more than 11 hours per day and taking less than 5000 steps per day while participating in exercise training.
Active walking with exercise.Behavioural
Subjects will commit to sitting less than 5 hours per day and taking more than 10000 steps per day while participating in exercise training.
| Study group | Role | What they receive |
|---|---|---|
| Sitting with Exercise | Active comparator | Subjects will complete a short term training protocol while sitting >11 hours per day. This training will be preceded by a VO2max test to aid in setting the correct intensity for training. Subjects will be asked to complete three high fat tolerance tests. One to establish a baseline, the second to determine the acute effects of training, and a third at the completion of training to determine the cumulative effect of exercise training. Receives: Behavioral: Prolonged sitting with exercise |
| Walking with exercise | Active comparator | Subjects will complete a short term training protocol while sitting <5 hours per day. This training will be preceded by a VO2max test to aid in setting the correct intensity for training. Subjects will be asked to complete three high fat tolerance tests. One to establish a baseline, the second to determine the acute effects of training, and a third at the completion of training to determine the cumulative effect of exercise training. Receives: Behavioral: Active walking with exercise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Triglycerides
Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Measured: 6 hours
Secondary outcomes (2)
Plasma Insulin
Areas under the curve for insulin concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Measured: 6 hours
Plasma glucose
Areas under the curve for glucose concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start17 Jul 2018
- Primary completion30 Apr 2020
- Study completion30 May 2020
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 AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- 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
- Subjects will be randomly assigned to either the sitting plus exercise or walking plus exercise.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edward F. Coyle, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352063
- Sponsor's protocol ID
- 2017-07-0074
- Status last verified
- Sep 2021
- First submitted
- 9 Oct 2017
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burton HM, Wolfe AS, Vardarli E, Satiroglu R, Coyle EF. Background Inactivity Blunts Metabolic Adaptations to Intense Short-Term Training. Med Sci Sports Exerc. 2021 Sep 1;53(9):1937-1944. doi: 10.1249/MSS.0000000000002646.
PubMed 34398061
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prolonged Sitting on Metabolic and Cardiovascular Responses to Short-Term Exercise Training
- ClinicalTrials.gov ID
- NCT03352063
- Acronym / sponsor ID
- 2017-07-0074
- Conditions
- Atherosclerosis, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 17 Jul 2018 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 24 Nov 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.
Prolonged sitting has been shown to effect the response to a high fat tolerance test (HFTT) after acute exercise. This study will evaluate the effect of prolonged sitting on response to a HFTT after a short term training period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects will be randomly assigned to either the sitting plus exercise or walking plus exercise.
| Arm | Type | Receives |
|---|---|---|
| Sitting with Exercise | Active comparator | Behavioral: Prolonged sitting with exerciseSubjects will complete a short term training protocol while sitting >11 hours per day. This training will be preceded by a VO2max test to aid in setting the correct intensity for training. Subjects will be asked to complete three high fat tolerance tests. One to establish a baseline, the second to determine the acute effects of training, and a third at the completion of training to determine the cumulative effect of exercise training. |
| Walking with exercise | Active comparator | Behavioral: Active walking with exercise.Subjects will complete a short term training protocol while sitting <5 hours per day. This training will be preceded by a VO2max test to aid in setting the correct intensity for training. Subjects will be asked to complete three high fat tolerance tests. One to establish a baseline, the second to determine the acute effects of training, and a third at the completion of training to determine the cumulative effect of exercise training. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18 to 35 years
Key exclusion criteria (6 listed)
- cardiovascular problems (e.g. pre-existing heart issues, coronary artery disease, hypertension, etc.)
- respiratory problems
- musculoskeletal problems that prevent prolonged sitting or exercise
- obesity
- susceptibility to fainting
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 |
|---|---|---|
| Prolonged sitting with exerciseSubjects will commit to sitting more than 11 hours per day and taking less than 5000 steps per day while participating in exercise training. | Behavioural | Sitting with Exercise |
| Active walking with exercise.Subjects will commit to sitting less than 5 hours per day and taking more than 10000 steps per day while participating in exercise training. | Behavioural | Walking with exercise |
Primary outcome
Plasma Triglycerides
Time frame: 6 hours
Areas under the curve for triglyceride concentration will be calculated for hourly samples from a 6-hour lipid tolerance test
2 secondary outcomes
Plasma Insulin
Time frame: 6 hours
Plasma glucose
Time frame: 6 hours
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 30 Sep 2021.
- Derived from this study: PubMed 34398061Burton HM, Wolfe AS, Vardarli E, Satiroglu R, Coyle EF. Background Inactivity Blunts Metabolic Adaptations to Intense Short-Term Training. Med Sci Sports Exerc. 2021 Sep 1;53(9):1937-1944. doi: 10.1249/MSS.0000000000002646.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged sitting with exercise and Active walking with exercise. in people with Atherosclerosis and Metabolic Syndrome, run by University of Texas at Austin at 1 site in United States.
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 1 inclusion and 6 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 30 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 United States. 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?
Plasma Triglycerides (time frame: 6 hours). 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 NCT03352063, 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 30 Sep 2021.