Cardiovascular DiseaseAEBNPCRPNCT02479269
The Influence of Aerobic Exercise on Serum Brain Natriuretic Peptide and C- Reactive Protein in Cardiovascular Disease
A study testing Aerobic exercise in people with Cardiovascular Disease, run by Shiraz University of Medical Sciences.
Trial summary
The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with cardiovascular disease. Patients were divided randomly into two groups: control and experimental aerobic group. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to May 2015
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- In this trial patients with coronary artery disease more than 70 percent at least in one coronary vessel with Ejection Fraction more than 40 percent in recent Echo cardiograph without acute evidence of ischemia or congestive heart failure symptoms were selected and are divide randomly into two groups.
Who cannot join
- Patients with acute evidence of ischemia or congestive heart failure symptoms are excluded.
About this study
The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with cardiovascular disease. Patients were divided randomly into two groups: control and experimental aerobic group. This study was done with two - stage blood sampling: at the beginning and at the end of the treatment phase. All subjects were requested to avoid any exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C - reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein. Blood samples for subsequent measurements were frozen immediately and transported to the Hormone Laboratory for serum separation. The experimental group did the aerobic exercise programs for 8 weeks for 3 sessions per week and the control group did not receive any training. After completion of training, the final blood samplings were performed. Exercise intensity according to the heart rate remained stable until the last week. Brain Natriuretic Peptide and C - reactive protein levels were measured by ELISA tests. All statistical analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05
- Conditions
- Cardiovascular Disease
- Being tested
- Aerobic exercise
- Keywords
- Brain Natriuretic Peptide, aerobic execise, C- Reactive Protein
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic exerciseOther
Aerobic exercise for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | Aerobic exercise+ blood sampling Receives: Other: Aerobic exercise |
| control | No intervention | Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Natriuretic Peptide
Measured: 8 weeks
serum C - reactive protein
Measured: 8 weeks
Secondary outcomes (3)
serum lipoproteins
Measured: 8 weeks
Body Mass Index
Measured: 8 weeks
blood pressure
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startMar 2015
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Islamic Azad University, Shiraz
- Responsible party
- Principal investigator, Najmeh Sheykhiyan, Islamic Azad University, Shiraz
- Investigators
- Dr Mohammad Ali Ostovan, Cardiologist, Study director, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479269
- Sponsor's protocol ID
- CT-P-92-6517
- Acronym
- AEBNPCRP
- Status last verified
- May 2016
- First submitted
- 13 Jun 2015
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Aerobic Exercise on Serum Brain Natriuretic Peptide and C- Reactive Protein in Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02479269
- Acronym / sponsor ID
- AEBNPCRP / CT-P-92-6517
- Conditions
- Cardiovascular Disease
- Keywords
- Brain Natriuretic Peptide, aerobic execise, C- Reactive Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Islamic Azad University, Shiraz
- Study start
- Mar 2015
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 24 Jun 2015 (estimated)
- 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 purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with cardiovascular disease. Patients were divided randomly into two groups: control and experimental aerobic group. This study was done with two - stage blood sampling: at the beginning and at the end of the treatment phase. All subjects were requested to avoid any exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C - reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein. Blood samples for subsequent measurements were frozen immediately and transported to the Hormone Laboratory for serum separation. The experimental group did the aerobic exercise programs for 8 weeks for 3 sessions per week and the control group did not receive any training. After completion of training, the final blood samplings were performed. Exercise intensity according to the heart rate remained stable until the last week. Brain Natriuretic Peptide and C - reactive protein levels were measured by ELISA tests. All statistical analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Other: Aerobic exerciseAerobic exercise+ blood sampling |
| control | No intervention | –Blood sampling |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- In this trial patients with coronary artery disease more than 70 percent at least in one coronary vessel with Ejection Fraction more than 40 percent in recent Echo cardiograph without acute evidence of ischemia or congestive heart failure symptoms were selected and are divide randomly into two groups.
Key exclusion criteria (1 listed)
- Patients with acute evidence of ischemia or congestive heart failure symptoms are excluded.
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 |
|---|---|---|
| Aerobic exerciseAerobic exercise for 8 weeks | Other | intervention |
Primary outcome
Brain Natriuretic Peptide
Time frame: 8 weeks
serum C - reactive protein
Time frame: 8 weeks
3 secondary outcomes
serum lipoproteins
Time frame: 8 weeks
Body Mass Index
Time frame: 8 weeks
blood pressure
Time frame: 8 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 10 May 2016.
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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.
Dr Mohammad Ali Ostovan, Cardiologist study director
Shiraz University of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic exercise in people with Cardiovascular Disease, run by Shiraz University of Medical Sciences.
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 1 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 10 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Brain Natriuretic Peptide (time frame: 8 weeks). The study lists 2 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 10 May 2016.