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

NCT ID: NCT02691806

Last Updated: 2016-02-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Muscle Fatigue

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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research arm

Each of the 14 participants will undergo the same 2 days experimental protocol, separated by at least 2 days rest.

Group Type EXPERIMENTAL

experimental protocol

Intervention Type OTHER

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.

Interventions

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experimental 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Haggai Schermann, M.D

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

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Sheba medical center

Tel Litwinsky, Ramat- Gan, Israel

Site Status

Countries

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Israel

Central Contacts

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Haggai Schermann, M.D

Role: CONTACT

+972828771014

Facility Contacts

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Haggai Schermann, M.D

Role: primary

+972-528771014

Other Identifiers

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SHEBA-16-2918-HS-CTIL

Identifier Type: -

Identifier Source: org_study_id

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