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

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.

Study Overview

• Status: Unknown
• Conditions: Muscle Fatigue
• Intervention / Treatment: Other: experimental protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Ramat- Gan
    • Tel-Hashomer, Ramat- Gan, Israel
      • Sheba Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
oxygen levels in the skin	oxygen levels in the skin will be measured using optic sensor at each leg in the muscular twins area.	1 day
anaerobic threshold	anaerobic threshold value is measured using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.	1 day
maximum oxygen consumption	oxygen consumption (VO2) will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.	1 day
heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	2 days
skin perfusion	skin perfusion (changes in blood volume) will be measured using Laser Doppler flowmetry (LDF) of Perimed system at each leg in the muscular twins area.	1 day

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): March 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: February 24, 2016
• First Posted (Estimate): February 25, 2016

Study Record Updates

• Last Update Posted (Estimate): February 25, 2016
• Last Update Submitted That Met QC Criteria: February 24, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: SHEBA-16-2918-HS-CTIL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No