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New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods

New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02691806
Enrollment
14
Registered
2016-02-25
Start date
2016-03-31
Completion date
2016-08-31
Last updated
2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Fatigue

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.

Detailed description

14 healthy volunteers, 7 males and 7 females, aged 18-30 will participate in this study.The study includes 2 stages: In the first stage, aerobic capacity of the subjects will be measured by measuring maximum oxygen consumption (VO2max test). This phase will be conducted to determine physical measurements that could indicate different stages in muscle fatigue (anaerobic threshold, maximum oxygen consumption, heart rate and breathing indices). In the second phase, the subjects will perform the same physical effort protocol that carried out at the first stage. Non- invasive measurements of leg muscles activity during aerobic exercise and at rest (before and after activity), will be carried out using a wireless EMG. Additionally, hemodynamic measurements of oxygen levels in the skin and skin perfusion monitoring before and after strenuous activity will be performed using two optic sensors.

Interventions

OTHERexperimental protocol

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.

Sponsors

Sheba Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

Inclusion criteria

* Aged 18-30 years. * Healthy civilian volunteers. * Without known medical illness or medication use that might endanger the participants.

Exclusion criteria

* The existence or suspicion of existing cardiac or respiratory disease. * Any metabolic disorder. * Any muscles or skeleton condition. * Any neurological condition. * the physician decision.

Design outcomes

Primary

MeasureTime frameDescription
electric activity of leg muscles1 daythe electric activity of leg muscles will be measured using 4 EMG electrodes, 2 in each leg (muscular twins and quadriceps muscle).

Secondary

MeasureTime frameDescription
oxygen levels in the skin1 dayoxygen levels in the skin will be measured using optic sensor at each leg in the muscular twins area.
anaerobic threshold1 dayanaerobic threshold value is measured using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.
maximum oxygen consumption1 dayoxygen consumption (VO2) will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.
heart rate2 daysThe heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
skin perfusion1 dayskin perfusion (changes in blood volume) will be measured using Laser Doppler flowmetry (LDF) of Perimed system at each leg in the muscular twins area.

Countries

Israel

Contacts

Primary ContactHaggai Schermann, M.D
Haggai.Schermann@sheba.health.gov.il+972828771014

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026