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

Muscle Fatigue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02691806
• Other study ID #: SHEBA-16-2918-HS-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: February 22, 2016
• Last updated: February 24, 2016
• Start date: March 2016
• Est. completion date: August 2016

Study information

• Verified date: February 2016
• Source: Sheba Medical Center
• Contact: Haggai Schermann, M.D
• Phone: +972828771014
• Email: Haggai.Schermann[@]sheba.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 14
• Est. completion date: August 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fatigue
• Muscle Fatigue

Intervention

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.

Locations

Country	Name	City	State
Israel	Sheba medical center	Tel-Hashomer	Ramat- Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	anaerobic threshold	anaerobic threshold value is measured using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.	1 day	No
Secondary	maximum oxygen consumption	oxygen consumption (VO2) will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.	1 day	No
Secondary	heart rate	The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).	2 days	Yes
Secondary	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	No