Exercise TestNCT05263687
Exercise Testing in Diseases and Health
A study testing Maximal exercise test in people with Exercise Test, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
Trial summary
Cardiopulmonary exercise test (CPET) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. CPET provides a full assessment of the physiologic responses of the pulmonary, cardiovascular, muscular, and cellular oxidative systems to exercise. Read more about this study
- Who is it for?
- Ages 4 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Test
- What is being tested?
- Maximal exercise test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Aug 2017to 30 Dec 2025
- 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 4 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient who invited to the clinic to do incremental maximal exercise test or healthy Participants with no known significant health problems.
Who cannot join
- Acute fever
- Acute myocardial infarction within 2 to 3 days.
- Unstable angina not previously stabilized by medical therapy.
- Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
- Symptomatic severe aortic stenosis.
- Uncontrolled symptomatic heart failure.
- Inability to perform exercise Orthopedic impairment severely compromising exercise performance.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The BARUCH PADEH Medical Center, Poriya
Tiberias, The Lower Galilee, 15208
Odelia Katz, okatz@poria.health.gov.il
About this study
Official title: Cardio Pulmonary Exercise Testing (CPET) in Diseases and Health
Cardiopulmonary exercise test (CPET) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. CPET provides a full assessment of the physiologic responses of the pulmonary, cardiovascular, muscular, and cellular oxidative systems to exercise. The test progression include a incremental stepwise (on treadmill) or ramp control protocol (on bike ergometer ) to exhaustion. Measurement of respiratory gas exchange i.e. oxygen uptake, carbon dioxide, minute ventilation, other variables while monitoring ECG, blood pressure, pulse oximetry and exertion perceived (Borg Scale) during an incremental test .
Aim: To compere exercise responses for maximal exercise testing with different population.
Read the detailed description
Each participants will conducted an exercise test on treadmill using Modified Bruce Protocol) or cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be use to collect and analysis gas exchange. 10 minute after the graded exercise test Supra maximal exercise test (SMT) will be done for 2 minutes one stage (treadmill protocol) or 10% at cycle protocol higher than highest load achieved in the incremental test.
all outcome measurement will be collected. Exercise tolerance and responses will be assess using the data of : pulmonary gas exchange; cardiovascular performance, and skeletal muscle metabolism.
- Conditions
- Exercise Test
- Being tested
- Maximal exercise test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal exercise testDiagnostic test
Each participants will conduct a spirometry test and exercise test on treadmill (using Modified Bruce Protocol) or cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used to collect and analysis gas exchange, ECG, gas volume in addition rating of perceived exertion will be asked.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Test | Experimental | maximal and anaerobic threshold cardiopulmonary parameters Receives: Diagnostic Test: Maximal exercise test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal Oxygen consumption
the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.
Measured: through study completion, an average of 1 year
Maximal Heart rate
the maximum heart rate achieved during intense or maximal exercise.
Measured: through study completion, an average of 1 year
Maximal Blood pressure
the blood pressure in the end of intense or maximal exercise.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Ventilation Anaerobic Threshold
Ventilatory Threshold (VT) describes the inflection point for ventilation during an incremental exercise test.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start30 Aug 2017
- Primary completion19 Mar 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TestStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gur Mainzer, The Baruch Padeh Medical Center, Poriya
- Investigators
- Gur Mainzer, MD, Principal investigator, The Baruch Padeh Medical Center, Poriya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05263687
- Sponsor's protocol ID
- 0033-17-POR
- Status last verified
- Mar 2022
- First submitted
- 13 Feb 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio Pulmonary Exercise Testing (CPET) in Diseases and Health
- ClinicalTrials.gov ID
- NCT05263687
- Acronym / sponsor ID
- 0033-17-POR
- Conditions
- Exercise Test
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- 30 Aug 2017 (actual)
- Primary completion
- 19 Mar 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 2 Mar 2022 (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.
Cardiopulmonary exercise test (CPET) is a helpful tool for evaluation of aerobic exercise capacity and tolerance for variety of population. CPET provides a full assessment of the physiologic responses of the pulmonary, cardiovascular, muscular, and cellular oxidative systems to exercise. The test progression include a incremental stepwise (on treadmill) or ramp control protocol (on bike ergometer ) to exhaustion. Measurement of respiratory gas exchange i.e. oxygen uptake, carbon dioxide, minute ventilation, other variables while monitoring ECG, blood pressure, pulse oximetry and exertion perceived (Borg Scale) during an incremental test .
Aim: To compere exercise responses for maximal exercise testing with different population.
Detailed description
Each participants will conducted an exercise test on treadmill using Modified Bruce Protocol) or cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be use to collect and analysis gas exchange. 10 minute after the graded exercise test Supra maximal exercise test (SMT) will be done for 2 minutes one stage (treadmill protocol) or 10% at cycle protocol higher than highest load achieved in the incremental test.
all outcome measurement will be collected. Exercise tolerance and responses will be assess using the data of : pulmonary gas exchange; cardiovascular performance, and skeletal muscle metabolism.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise Test | Experimental | Diagnostic Test: Maximal exercise testmaximal and anaerobic threshold cardiopulmonary parameters |
Who may qualify
- Ages
- 4 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient who invited to the clinic to do incremental maximal exercise test or healthy Participants with no known significant health problems.
Key exclusion criteria (7 listed)
- Acute fever
- Acute myocardial infarction within 2 to 3 days.
- Unstable angina not previously stabilized by medical therapy.
- Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise.
- Symptomatic severe aortic stenosis.
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 |
|---|---|---|
| Maximal exercise testEach participants will conduct a spirometry test and exercise test on treadmill (using Modified Bruce Protocol) or cycle ergometer. Quark CPET metabolic cart (Cosmed, Rome, Italy) will be used to collect and analysis gas exchange, ECG, gas volume in addition rating of perceived exertion will be asked. | Diagnostic test | Exercise Test |
Primary outcome
Maximal Oxygen consumption
Time frame: through study completion, an average of 1 year
the maximum amount of oxygen that an individual can utilize during intense or maximal exercise.
Maximal Heart rate
Time frame: through study completion, an average of 1 year
the maximum heart rate achieved during intense or maximal exercise.
Maximal Blood pressure
Time frame: through study completion, an average of 1 year
the blood pressure in the end of intense or maximal exercise.
1 secondary outcome
Ventilation Anaerobic Threshold
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- 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.
Gur Mainzer, MD principal investigator
The Baruch Padeh Medical Center, Poriya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal exercise test in people with Exercise Test, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 21 Mar 2022. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gur Mainzer, MD (+972543078940, GMainzer@poria.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal Oxygen consumption (time frame: through study completion, an average of 1 year). The study lists 3 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 21 Mar 2022.