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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06370403
Other study ID # LithuanianSportsU-21
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2014
Est. completion date January 8, 2017

Study information

Verified date April 2024
Source Lithuanian Sports University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Local head and neck cooling strategies can help reduce multiple sclerosis-related fatigue, while heating can exacerbate heat-related fatigue. However, no study has detailed the peripheral and central responses to head and neck cooling (at 18°C) and heating (at 43 ± 1°C next to the scalp and neck skin) during fatiguing isometric exercise in non-challenging ambient temperature in multiple sclerosis and healthy male subjects. In addition, there is a lack of data describing the effects of head and neck cooling/heating and strenuous exercise on blood markers, muscle temperature, motor accuracy, and rate of perceived exertion. The investigators hypothesized that: (i) men with multiple sclerosis would be more affected by central and peripheral fatigue compared to healthy subjects; (ii) local cooling will result in greater central fatigue but will be associated with greater peripheral fatigue, whereas heating will result in greater central and peripheral fatigue in multiple sclerosis men; (iv) local cooling and heating will have a greater effect on the release of stress hormones, rate of perceived exertion and motor accuracy compared to the control condition in both multiple sclerosis and healthy groups.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date January 8, 2017
Est. primary completion date March 1, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 45 Years
Eligibility Inclusion criteria: - Relapsing-remitting multiple sclerosis disease course according to McDonald criteria - Expanded Disability Status Scale less than 4 points and Fatigue Severity Scale score greater than 5 points in participants with multiple sclerosis - Males - Age between 18 and 45 years - Sufficient tolerance to electrical stimulation Exclusion Criteria: - Physical limitations that would impair the ability to perform neuromuscular testing - Mental disorders, such as depression or anxiety, due to their recognized association with fatigue - Involvement in temperature manipulation program for = 3 months - Attending any excessive physical exercise or sports programs - With blood/needle phobia

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Cooling of the head and neck
Cooling of the head and neck at 18°C next to the head and neck skin in multiple sclerosis and healthy subjects
Heating of the head and neck
Heating of the head and neck at 43 ± 1°C next to the head and neck skin in multiple sclerosis

Locations

Country Name City State
Lithuania Lithuanian Sports University Kaunas

Sponsors (1)

Lead Sponsor Collaborator
Lithuanian Sports University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body weight (kg) Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan). Every time in all conditions at the baseline
Primary Body fat (%) Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan). Every time in all conditions at the baseline
Primary Body free fat mass (kg) Body free fat mass (kg) was evaluated using Tanita Body Composition Analyzer (Japan). Every time in all conditions at the baseline
Primary Body mass index (kg/m2) The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height. Every time in all conditions at the baseline
Primary Change in muscle temperature (°C) Muscle temperature was measured using a needle microprobe (Intramuscular Probe MKA, thermometer model DM-852, Ellab) inserted approximately 3 cm beneath the skin surface into the vastus lateralis muscle of the right leg. Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in plasma cortisol (nmol/L) concentrations Plasma cortisol concentrations (nmol/L) were measured using an AIA-2000 automated enzyme immunoassay analyser (Tosoh Corp, Tokyo, Japan). Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in plasma dopamine (nmol/L) concentrations Dopamine concentrations (nmol/L) were measured using a kit for dopamine enzyme-linked immunosorbent assay (ELISA) (IBL, Hamburg, Germany). Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in plasma prolactin (ng/mL) concentrations Prolactin levels (ng/mL) were measured using a kit for prolactin ELISA (IBL) and Gemini analyzer (Stratec Biomedical GmbH, Germany). Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in subjective rating of perceived exertion Perceived exertion was assessed using the Borg scale, ranging from 6 (no exertion) to 20 (maximum exertion). Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in muscle activity (mV) Vastus medialis and vastus lateralis electromyographic (EMG) amplitude (in mV) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment. Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in muscle activity (Hz) Vastus medialis and vastus lateralis muscles electromyographic (EMG) frequency (in Hz) parameters of muscular activity were measured using surface EMG (Biometrics, UK) thorough neuromuscular function assessment. Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in voluntary torque (Nm) Isometric and isokinetic voluntary torques (in Nm) of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA). Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in involuntary torque (Nm) Involuntary torque of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA) and a high-voltage stimulator (Digitimer DS7A, Digitimer, UK). Peak torques (in Nm) induced by electrical stimulation at 20 Hz,at 100 Hz, and at TT100 were measured. Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in muscle contraction and relaxation (ms) The contraction and half-relaxation time (in ms) were measured in 100Hz stimulated contractions. Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in central activation ratio (percent) To evaluate central activation ratio (CAR), a TT-100 Hz stimuli was superimposed on the maximal voluntary contraction (MVC), and the CAR was computed using the following equation: CAR = MVC/(MVC+TT-100 Hz) × 100percent, where where a CAR of 100 percent indicates complete activation of the exercising muscle and a CAR < 100 percent indicates central activation failure or inhibition. Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in constant error The accuracy of the intermittent isometric contraction tasks was calculated as a constant error. Constant error = ?(xi - T)/n where xi is the motor task performed (N·m); T is the target quantity, i.e., the motor task required; n is the number of trials; and S indicates the mean that was calculated considering the algebraic symbols (±). Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Primary Change in absolute error The absolute error specifies the absolute deviation from the required target force. Absolute error = ?|xi - T|/n where xi is the motor task performed (N·m); T is the target quantity, i.e., the motor task required; n is the number of trials; and vertical brackets S | | indicate the mean that was calculated without considering the algebraic symbols (±). Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Secondary Height (m) Height (in m) was measured using a Harpenden anthropometer set (Holtain Ltd, UK) Every time in all conditions at the baseline
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