ExercisePhase 1NCT02882672
Changes in Adiponectin and Cardiovascular Disease Risk Factors in Overweight Patients
A Phase 1 study testing Experimental in people with Exercise and Cardiac Myosins, run by University of Isfahan.
Trial summary
This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could improve adiponectin and cardiovascular disease risk factors in overweight coronary heart disease patients. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Cardiac Myosins, Patients
- What is being tested?
- Experimental
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jun 2016
- Phase
- Phase 1
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- they were approved to do so following a physical, physiological and psychological test; resided and worked in the city of Isfahan; did not take part in regular physical activity; had stable heart failure for at least 3 months.
Who cannot join
- a history of surgery within the preceding 4 months
- had an unstable angina, acute phase of myocardial infarction (MI), and/or unstable arrhythmia
- had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury (mmHg), aortic stenosis, and/or peripheral artery disease
- exercise limitations due to neuromuscular and/or musculoskeletal disease, such as any type of orthopedic, low back pain, bone fracture of less than 6 months
- uncontrolled systemic disease, such as DM; were 75 years or older
- had any health problems that prevented maximum effort on the treadmill test
- unable to answer the screening questionnaires assessing depression and anxiety.
About this study
Official title: Exercise-based Cardiac Rehabilitation
This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could improve adiponectin and cardiovascular disease risk factors in overweight coronary heart disease patients. Patients were included in the study if: they were approved to do so following a physical, physiological and psychological test; did not take part in regular physical activity; had stable heart failure for at least 3 months. Exclusion criteria included: a history of surgery within the preceding 4 months; had an unstable angina, acute phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease; exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health problems that prevented maximum effort on the treadmill test. Target population included of all patients with a history of myocardial infarction and diagnosis of congestive heart failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary heart disease patients were randomly assigned to either an eight-week, three times weekly exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging, flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.
- Conditions
- Exercise, Cardiac Myosins, Patients
- Being tested
- Experimental, Control
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Doing exercise at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging
ControlOther
They did not do ant exercise training during 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | experimental group did 8 weeks exercise training Receives: Other: Experimental |
| Control | Experimental | Control group did not do any exercise training. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Exercise-based cardiac rehabilitation on Serum levels of adiponectin was measured by ELISA method
Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes.
Measured: up to 8 weeks
Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method
Measured: up to 8 weeks
Secondary outcomes (2)
Effect of Exercise-based cardiac rehabilitation on weight was measured
Measured: up to 8 weks
Effect of Exercise-based cardiac rehabilitation on height was measured
Measured: up to 8 weks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2016 (estimated)
- Study startJan 2016
- Primary completionMar 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Isfahan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof.Mehdi Kargarfard, University of Isfahan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882672
- Sponsor's protocol ID
- 201527898IR
- Status last verified
- Aug 2016
- First submitted
- 12 Aug 2016
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise-based Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT02882672
- Acronym / sponsor ID
- 201527898IR
- Conditions
- Exercise, Cardiac Myosins, Patients
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of IsfahanUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Aug 2016 (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.
This study aimed to determine if eight-weeks of exercise-based cardiac rehabilitation could improve adiponectin and cardiovascular disease risk factors in overweight coronary heart disease patients. Patients were included in the study if: they were approved to do so following a physical, physiological and psychological test; did not take part in regular physical activity; had stable heart failure for at least 3 months. Exclusion criteria included: a history of surgery within the preceding 4 months; had an unstable angina, acute phase of myocardial infarction, and/or unstable arrhythmia; had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury, aortic stenosis, and/or peripheral artery disease; exercise limitations due to neuromuscular and/or musculoskeletal disease; had any health problems that prevented maximum effort on the treadmill test. Target population included of all patients with a history of myocardial infarction and diagnosis of congestive heart failure who were referred to Isfahan Cardiovascular Research Centre. 60overweight coronary heart disease patients were randomly assigned to either an eight-week, three times weekly exercise group (n=30), or a non-exercising control group (n=30). Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging, flexibility, balance exercises, and weight-bearing activity and a 10-minute cool-down.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Experimentalexperimental group did 8 weeks exercise training |
| Control | Experimental | Other: ControlControl group did not do any exercise training. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- they were approved to do so following a physical, physiological and psychological test; resided and worked in the city of Isfahan; did not take part in regular physical activity; had stable heart failure for at least 3 months.
Key exclusion criteria (7 listed)
- a history of surgery within the preceding 4 months
- had an unstable angina, acute phase of myocardial infarction (MI), and/or unstable arrhythmia
- had obstructive cardiomyopathy, exercise-induced ischemia or arrhythmias, uncontrolled arrhythmias, resting blood pressure more than 200/120 millimeters mercury (mmHg), aortic stenosis, and/or peripheral artery disease
- exercise limitations due to neuromuscular and/or musculoskeletal disease, such as any type of orthopedic, low back pain, bone fracture of less than 6 months
- uncontrolled systemic disease, such as DM; were 75 years or older
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 |
|---|---|---|
| ExperimentalDoing exercise at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging | Other | Experimental |
| ControlThey did not do ant exercise training during 8 weeks. | Other | Control |
Primary outcome
Effect of Exercise-based cardiac rehabilitation on Serum levels of adiponectin was measured by ELISA method
Time frame: up to 8 weeks
Exercise sessions took place at 60-85% of maximal heart rate, lasted 45-60 minutes.
Effect of Exercise-based cardiac rehabilitation on lipids was measured by ELISA method
Time frame: up to 8 weeks
2 secondary outcomes
Effect of Exercise-based cardiac rehabilitation on weight was measured
Time frame: up to 8 weks
Effect of Exercise-based cardiac rehabilitation on height was measured
Time frame: up to 8 weks
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 Aug 2016.
- 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Experimental in people with Exercise and Cardiac Myosins, run by University of Isfahan.
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 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 30 Aug 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Effect of Exercise-based cardiac rehabilitation on Serum levels of adiponectin was measured by ELISA method (time frame: up to 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 30 Aug 2016.