Multiple Sclerosis Clinical Trial
Official title:
Effects of Head and Neck Cooling and Heating on Central and Peripheral Fatigue, Motor Accuracy and Blood Markers of Stress in Multiple Sclerosis and Healthy Men
Verified date | April 2024 |
Source | Lithuanian Sports University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Lithuania | Lithuanian Sports University | Kaunas |
Lead Sponsor | Collaborator |
---|---|
Lithuanian Sports University |
Lithuania,
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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