Anaerobic PerformanceNCT01770288
Psychophysical Aspects of Maximal Anaerobic Performance
A study testing Anaerobic wingate test in people with Anaerobic Performance, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is a marker to the increased protons concentration and acidosis.nevertheless, the increased level of protons in addition to the release of… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaerobic Performance
- What is being tested?
- Anaerobic wingate test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Apr 2013
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy Volunteers
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Einat Kodesh, PhD contact
Israel1 site
Zinman College for Physical Education and Sport Sciences at the Wingate Institute
Netanya, 42902
Yoav Mekel, PhD
Irit Weisman-Fogel, PhD
About this study
During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is a marker to the increased protons concentration and acidosis.nevertheless, the increased level of protons in addition to the release of bradykinin causes pain during the exercise that limited the subject's performance. Therefore, it is assumed that the individual pain sensitivity might determine the subject's performance.
Aims: To investigate the role of the DNIC efficiency in prediction of anaerobic performance in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain during anaerobic exercise and its contribution to the subjects' performance (3) to assess the function of pain-related psychological factors in anaerobic performance.
Read the detailed description
To the best of our knowledge, no study has investigated the balance between the endogenous anti-nociceptive properties of the individual and the anaerobic-evoke pro-nociceptive activity in determining the maximal performance during anaerobic exercise. Moreover, the interaction between psychological factors and pro- and anti- nociceptive processes that are operated during anaerobic exercise, need to be investigated.
Methods: Forty healthy men and women, between the ages of 18-40 will be involved in the study. Each participant will complete 3 psychological questionnaires regarding their personality traits: Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory and Perceived Stress Questionnaire. Pain psychophysics tests will be used for evaluating the individual pain perception, prior and subsequent to the anaerobic exercise: (1) DNIC will be tested using a paradigm of two remote noxious stimuli with one, the 'conditioning stimulus' (immersing the hand in tub containing 8°c water), inhibiting the other, the 'test pain' (pressure pain threshold) in order to assess the endogenous analgesia (EA) efficiency (2) heat and pressure pain thresholds, and (3) temporal summation of painful heat and mechanical stimuli that reflect the neuroplasticity of the central nervous system following peripheral noxious stimulation. In addition, Anaerobic performance will be evaluated during Wingate test,and blood lactate will be measured. Gene related pain ill be tested using saliva samples .
- Conditions
- Anaerobic Performance
- Being tested
- Anaerobic wingate test
- Keywords
- Anerobic exercise, Pain, Analgesia, Diffuse Noxious Inhibitory Control (DNIC), psychological stress
- Medical subject headings
- Pain, Agnosia, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaerobic wingate testOther
| Study group | Role | What they receive |
|---|---|---|
| Anaerobic Performance | Experimental | Not described Receives: Other: Anaerobic wingate test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain psychophysics tests
DNIC will be tested using a paradigm of two remote noxious stimuli with one, the 'conditioning stimulus' (immersing the hand in tub containing 8°c water), inhibiting the other, the 'test pain' (pressure pain threshold) in order to assess the EA efficiency (2) heat and pressure pain thresholds, and (3) temporal summation of painful heat and mechanical stimuli that reflect the neuroplasticity of the central nervous system following peripheral noxious stimulation.
Measured: 1 year
Secondary outcomes (2)
Lactate concentration
Lactate concentration at rest will be measures using a portable lactate analyzer
Measured: 1 year
The anaerobic performance
will be evaluated during executing of Wingate test
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionFeb 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anaerobic PerformanceStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- University of Haifa, Zinman College of Physical Education and Sports Sciences
- Responsible party
- Sponsor
- Investigators
- Einat Kodesh, PhD, Principal investigator, University of Haifa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01770288
- Sponsor's protocol ID
- 8-12
- Status last verified
- Jan 2013
- First submitted
- 6 Jan 2013
- Last updated
- 17 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysical Aspects of Maximal Anaerobic Performance
- ClinicalTrials.gov ID
- NCT01770288
- Acronym / sponsor ID
- 8-12
- Conditions
- Anaerobic Performance
- Keywords
- Anerobic exercise, Pain, Analgesia, Diffuse Noxious Inhibitory Control (DNIC), psychological stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- University of Haifa, Zinman College of Physical Education and Sports Sciences
- Study start
- Feb 2013
- Primary completion
- Feb 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 17 Jan 2013 (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.
During anaerobic exercise, the metabolic pathway of glycolysis is used in order to produces high-energy compounds adenosine triphosphate (ATP).The level of lactic acid in the blood is a marker to the increased protons concentration and acidosis.nevertheless, the increased level of protons in addition to the release of bradykinin causes pain during the exercise that limited the subject's performance. Therefore, it is assumed that the individual pain sensitivity might determine the subject's performance.
Aims: To investigate the role of the DNIC efficiency in prediction of anaerobic performance in humans (2) to study the role of peripheral pro-nociceptive processing in mediating pain during anaerobic exercise and its contribution to the subjects' performance (3) to assess the function of pain-related psychological factors in anaerobic performance.
Detailed description
To the best of our knowledge, no study has investigated the balance between the endogenous anti-nociceptive properties of the individual and the anaerobic-evoke pro-nociceptive activity in determining the maximal performance during anaerobic exercise. Moreover, the interaction between psychological factors and pro- and anti- nociceptive processes that are operated during anaerobic exercise, need to be investigated.
Methods: Forty healthy men and women, between the ages of 18-40 will be involved in the study. Each participant will complete 3 psychological questionnaires regarding their personality traits: Pain Catastrophizing Scale (PCS), State-Trait Anxiety Inventory and Perceived Stress Questionnaire. Pain psychophysics tests will be used for evaluating the individual pain perception, prior and subsequent to the anaerobic exercise: (1) DNIC will be tested using a paradigm of two remote noxious stimuli with one, the 'conditioning stimulus' (immersing the hand in tub containing 8°c water), inhibiting the other, the 'test pain' (pressure pain threshold) in order to assess the endogenous analgesia (EA) efficiency (2) heat and pressure pain thresholds, and (3) temporal summation of painful heat and mechanical stimuli that reflect the neuroplasticity of the central nervous system following peripheral noxious stimulation. In addition, Anaerobic performance will be evaluated during Wingate test,and blood lactate will be measured. Gene related pain ill be tested using saliva samples .
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anaerobic Performance | Experimental | Other: Anaerobic wingate test |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy Volunteers
Key exclusion criteria (1 listed)
- pregnancy
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 |
|---|---|---|
| Anaerobic wingate test | Other | Anaerobic Performance |
Primary outcome
Pain psychophysics tests
Time frame: 1 year
DNIC will be tested using a paradigm of two remote noxious stimuli with one, the 'conditioning stimulus' (immersing the hand in tub containing 8°c water), inhibiting the other, the 'test pain' (pressure pain threshold) in order to assess the EA efficiency (2) heat and pressure pain thresholds, and (3) temporal summation of painful heat and mechanical stimuli that reflect the neuroplasticity of the central nervous system following peripheral noxious stimulation.
2 secondary outcomes
Lactate concentration
Time frame: 1 year
The anaerobic performance
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
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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.
Einat Kodesh, PhD contact
Einat Kodesh, PhD principal investigator
University of Haifa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anaerobic wingate test in people with Anaerobic Performance, run by Hillel Yaffe Medical Center 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 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: status not confirmed, as of the sponsor's last update on 17 Jan 2013. 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 Einat Kodesh, PhD (ekodesh@univ.haifa.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain psychophysics tests (time frame: 1 year). 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 17 Jan 2013.