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

S

Sheba Medical Center

Status

Unknown

Conditions

Muscle Fatigue

Treatments

Other: experimental protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT02691806
SHEBA-16-2918-HS-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment

14 estimated patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

14 participants in 1 patient group

research arm
Experimental group
Description:
Each of the 14 participants will undergo the same 2 days experimental protocol, separated by at least 2 days rest.
Treatment:
Other: experimental protocol

Trial contacts and locations

1

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Central trial contact

Haggai Schermann, M.D

Data sourced from clinicaltrials.gov

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