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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01770288
Other study ID # 8-12
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 6, 2013
Last updated January 15, 2013
Start date February 2013
Est. completion date April 2013

Study information

Verified date January 2013
Source Hillel Yaffe Medical Center
Contact Einat Kodesh, PhD
Email ekodesh@univ.haifa.ac.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical 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 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.


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 .


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date April 2013
Est. primary completion date February 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

healthy Volunteers

Exclusion Criteria:

pregnancy

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening


Related Conditions & MeSH terms


Intervention

Other:
Anaerobic wingate test


Locations

Country Name City State
Israel Zinman College for Physical Education and Sport Sciences at the Wingate Institute Netanya

Sponsors (3)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center University of Haifa, Zinman College of Physical Education and Sports Sciences

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year No
Secondary Lactate concentration Lactate concentration at rest will be measures using a portable lactate analyzer 1 year No
Secondary The anaerobic performance will be evaluated during executing of Wingate test 1 year No