New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods
1 other identifier
interventional
14
1 country
1
Brief Summary
Sometimes, during strenuous aerobic activity, activity ceases only when the discomfort that follows lack of oxygen would be intolerable. Reaching this fatigue condition can cause organ damage, muscular damage and / or in different tissues of the body. In this study, investigators aim at developing new indexes, based on hemodynamics measurements from the peripheral micro - circulation system, for the benefit of early detection of fatigue during accelerated physical activity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2016
CompletedFirst Posted
Study publicly available on registry
February 25, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFebruary 25, 2016
February 1, 2016
Same day
February 22, 2016
February 24, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
electric activity of leg muscles
the electric activity of leg muscles will be measured using 4 EMG electrodes, 2 in each leg (muscular twins and quadriceps muscle).
1 day
Secondary Outcomes (5)
oxygen levels in the skin
1 day
anaerobic threshold
1 day
maximum oxygen consumption
1 day
heart rate
2 days
skin perfusion
1 day
Study Arms (1)
research arm
EXPERIMENTALEach of the 14 participants will undergo the same 2 days experimental protocol, separated by at least 2 days rest.
Interventions
first day- VO2max test with the following measurements: anaerobic threshold, maximum oxygen consumption, heart rate and breathing indices. second day- performing the same physical protocol of VO2max test with the measurements: leg muscles activity using a wireless EMG, hemodynamic measurements of oxygen levels in the skin and skin perfusion, the two latest using optic sensors.
Eligibility Criteria
You may qualify if:
- Aged 18-30 years.
- Healthy civilian volunteers.
- Without known medical illness or medication use that might endanger the participants.
You may not qualify if:
- The existence or suspicion of existing cardiac or respiratory disease.
- Any metabolic disorder.
- Any muscles or skeleton condition.
- Any neurological condition.
- the physician decision.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba medical center
Tel Litwinsky, Ramat- Gan, Israel
Study Officials
- PRINCIPAL INVESTIGATOR
Haggai Schermann, M.D
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 22, 2016
First Posted
February 25, 2016
Study Start
March 1, 2016
Primary Completion
March 1, 2016
Study Completion
August 1, 2016
Last Updated
February 25, 2016
Record last verified: 2016-02
Data Sharing
- IPD Sharing
- Will not share