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Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06370403
Enrollment
40
Registered
2024-04-17
Start date
2014-02-04
Completion date
2017-01-08
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis, Cooling, Heating, Fatigue, Exercise

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.

Interventions

OTHERCooling 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

OTHERHeating 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

Sponsors

Lithuanian Sports University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Masking description

The researchers who analyzed the venous blood samples were blinded.

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in absolute errorBaseline, up to 60 minutes, up to 120 minutes, after 180minutesThe 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 (±).
Body weight (kg)Every time in all conditions at the baselineBody weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Body fat (%)Every time in all conditions at the baselineBody fat (%) was assessed using Tanita Body Composition Analyzer (Japan).
Body free fat mass (kg)Every time in all conditions at the baselineBody free fat mass (kg) was evaluated using Tanita Body Composition Analyzer (Japan).
Body mass index (kg/m2)Every time in all conditions at the baselineThe body mass index (in kg/m2) was defined as the body mass divided by the square of the body height.
Change in muscle temperature (°C)Baseline, up to 60 minutes, up to 120 minutes, after 180minutesMuscle 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) concentrationsBaseline, up to 60 minutes, up to 120 minutes, after 180minutesPlasma cortisol concentrations (nmol/L) were measured using an AIA-2000 automated enzyme immunoassay analyser (Tosoh Corp, Tokyo, Japan).
Change in plasma dopamine (nmol/L) concentrationsBaseline, up to 60 minutes, up to 120 minutes, after 180minutesDopamine concentrations (nmol/L) were measured using a kit for dopamine enzyme-linked immunosorbent assay (ELISA) (IBL, Hamburg, Germany).
Change in plasma prolactin (ng/mL) concentrationsBaseline, up to 60 minutes, up to 120 minutes, after 180minutesProlactin levels (ng/mL) were measured using a kit for prolactin ELISA (IBL) and Gemini analyzer (Stratec Biomedical GmbH, Germany).
Change in subjective rating of perceived exertionBaseline, up to 60 minutes, up to 120 minutes, after 180minutesPerceived exertion was assessed using the Borg scale, ranging from 6 (no exertion) to 20 (maximum exertion).
Change in muscle activity (mV)Baseline, up to 60 minutes, up to 120 minutes, after 180minutesVastus 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 muscle activity (Hz)Baseline, up to 60 minutes, up to 120 minutes, after 180minutesVastus 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 voluntary torque (Nm)Baseline, up to 60 minutes, up to 120 minutes, after 180minutesIsometric and isokinetic voluntary torques (in Nm) of the quadriceps muscles were measured using an isokinetic dynamometer (Biodex Medical Systems, USA).
Change in involuntary torque (Nm)Baseline, up to 60 minutes, up to 120 minutes, after 180minutesInvoluntary 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 180minutesThe 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 180minutesTo 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 constant errorBaseline, up to 60 minutes, up to 120 minutes, after 180minutesThe 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 (±).

Secondary

MeasureTime frameDescription
Height (m)Every time in all conditions at the baselineHeight (in m) was measured using a Harpenden anthropometer set (Holtain Ltd, UK)

Countries

Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026