Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men
- Conditions
- Multiple Sclerosis
- Interventions
- Other: Heating of the head and neckOther: Cooling of the head and neck
- Registration Number
- NCT06370403
- Lead Sponsor
- Lithuanian Sports University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 40
Not provided
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Heating of the head and neck in multiple sclerosis and healthy subjects Heating of the head and neck Multiple sclerosis and healthy male subjects participated in the head and heating program. During heating procedure, the participant performed fatiguing isometric motor task with a head and neck heating helmet at (43°C± 1°C next to the head and neck skin). Cooling of the head and neck in multiple sclerosis and healthy subjects Cooling of the head and neck Multiple sclerosis and healthy male subjects participated in the head and neck cooling program. During cooling procedure, the participant performed fatiguing isometric motor task with a head and neck cooling helmet at (18°C next to the head and neck skin).
- Primary Outcome Measures
Name Time Method Body mass index (kg/m2) Every time in all conditions at the baseline The body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.
Body fat (%) Every time in all conditions at the baseline Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan).
Body free fat mass (kg) Every time in all conditions at the baseline Body free fat mass (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Change in muscle temperature (°C) Baseline, up to 60 minutes, up to 120 minutes, after 180minutes 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.
Change in plasma cortisol (nmol/L) concentrations Baseline, up to 60 minutes, up to 120 minutes, after 180minutes Plasma cortisol concentrations (nmol/L) were measured using an AIA-2000 automated enzyme immunoassay analyser (Tosoh Corp, Tokyo, Japan).
Change in plasma dopamine (nmol/L) concentrations Baseline, up to 60 minutes, up to 120 minutes, after 180minutes Dopamine concentrations (nmol/L) were measured using a kit for dopamine enzyme-linked immunosorbent assay (ELISA) (IBL, Hamburg, Germany).
Change in plasma prolactin (ng/mL) concentrations Baseline, up to 60 minutes, up to 120 minutes, after 180minutes Prolactin levels (ng/mL) were measured using a kit for prolactin ELISA (IBL) and Gemini analyzer (Stratec Biomedical GmbH, Germany).
Body weight (kg) Every time in all conditions at the baseline Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Change in involuntary torque (Nm) Baseline, up to 60 minutes, up to 120 minutes, after 180minutes 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.
Change in muscle contraction and relaxation (ms) Baseline, up to 60 minutes, up to 120 minutes, after 180minutes The contraction and half-relaxation time (in ms) were measured in 100Hz stimulated contractions.
Change in central activation ratio (percent) Baseline, up to 60 minutes, up to 120 minutes, after 180minutes 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.
Change in muscle activity (Hz) Baseline, up to 60 minutes, up to 120 minutes, after 180minutes 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.
Change in constant error Baseline, up to 60 minutes, up to 120 minutes, after 180minutes 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 Σ indicates the mean that was calculated considering the algebraic symbols (±).
Change in muscle activity (mV) Baseline, up to 60 minutes, up to 120 minutes, after 180minutes 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.
Change in subjective rating of perceived exertion Baseline, up to 60 minutes, up to 120 minutes, after 180minutes Perceived exertion was assessed using the Borg scale, ranging from 6 (no exertion) to 20 (maximum exertion).
Change in voluntary torque (Nm) Baseline, up to 60 minutes, up to 120 minutes, after 180minutes Isometric and isokinetic voluntary torques (in Nm) of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).
Change in absolute error Baseline, up to 60 minutes, up to 120 minutes, after 180minutes 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 Σ \| \| indicate the mean that was calculated without considering the algebraic symbols (±).
- Secondary Outcome Measures
Name Time Method Height (m) Every time in all conditions at the baseline Height (in m) was measured using a Harpenden anthropometer set (Holtain Ltd, UK)
Trial Locations
- Locations (1)
Lithuanian Sports University
🇱🇹Kaunas, Lithuania