New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods
Primary Purpose
Muscle Fatigue
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
experimental protocol
Sponsored by
About this trial
This is an interventional diagnostic trial for Muscle Fatigue
Eligibility Criteria
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.
Sites / Locations
- Sheba medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
research arm
Arm Description
Each of the 14 participants will undergo the same 2 days experimental protocol, separated by at least 2 days rest.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
oxygen levels in the skin
oxygen levels in the skin will be measured using optic sensor at each leg in the muscular twins area.
anaerobic threshold
anaerobic threshold value is measured using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.
maximum oxygen consumption
oxygen consumption (VO2) will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.
heart rate
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
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.
Full Information
NCT ID
NCT02691806
First Posted
February 22, 2016
Last Updated
February 24, 2016
Sponsor
Sheba Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02691806
Brief Title
New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods
Official Title
New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods
Study Type
Interventional
2. Study Status
Record Verification Date
February 2016
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Fatigue
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
research arm
Arm Type
Experimental
Arm Description
Each of the 14 participants will undergo the same 2 days experimental protocol, separated by at least 2 days rest.
Intervention Type
Other
Intervention Name(s)
experimental protocol
Intervention Description
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.
Primary Outcome Measure Information:
Title
electric activity of leg muscles
Description
the electric activity of leg muscles will be measured using 4 EMG electrodes, 2 in each leg (muscular twins and quadriceps muscle).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
oxygen levels in the skin
Description
oxygen levels in the skin will be measured using optic sensor at each leg in the muscular twins area.
Time Frame
1 day
Title
anaerobic threshold
Description
anaerobic threshold value is measured using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.
Time Frame
1 day
Title
maximum oxygen consumption
Description
oxygen consumption (VO2) will be monitored continuously using a metabolic system (ERGOTEST 680, ZAN, GERMANY ) during VO2max test.
Time Frame
1 day
Title
heart rate
Description
The heart rate will be monitored using a wearable heart rate monitor (Polar® sensor and heart rate monitor watch).
Time Frame
2 days
Title
skin perfusion
Description
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.
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haggai Schermann, M.D
Phone
+972828771014
Email
Haggai.Schermann@sheba.health.gov.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haggai Schermann, M.D
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba medical center
City
Tel-Hashomer
State/Province
Ramat- Gan
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haggai Schermann, M.D
Phone
+972-528771014
Email
Haggai.Schermann@sheba.health.gov.il
First Name & Middle Initial & Last Name & Degree
Haggai Schermann, M.D
12. IPD Sharing Statement
Plan to Share IPD
No
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New Indices for Prediction of Human Fatigue During Training Based on Non-invasive Methods
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