Clinical trial NCT06370403: Effects of Head and Neck Cooling and Heating on Fatigue in Multiple Sclerosis and Healthy Men
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Cooling
Heating
Fatigue
Exercise
Lead sponsor: Lithuanian Sports University
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Body weight (kg)
timeFrame: Every time in all conditions at the baseline
measure: Body fat (%)
timeFrame: Every time in all conditions at the baseline
measure: Body free fat mass (kg)
timeFrame: Every time in all conditions at the baseline
measure: Body mass index (kg/m2)
timeFrame: Every time in all conditions at the baseline
measure: Change in muscle temperature (°C)
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in plasma cortisol (nmol/L) concentrations
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in plasma dopamine (nmol/L) concentrations
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in plasma prolactin (ng/mL) concentrations
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in subjective rating of perceived exertion
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in muscle activity (mV)
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in muscle activity (Hz)
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in voluntary torque (Nm)
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in involuntary torque (Nm)
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in muscle contraction and relaxation (ms)
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in central activation ratio (percent)
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in constant error
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
measure: Change in absolute error
timeFrame: Baseline, up to 60 minutes, up to 120 minutes, after 180minutes
Secondary outcomes:
measure: Height (m)
timeFrame: Every time in all conditions at the baseline
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian Sports University
Study officials:
affiliation: Lithuanian Sports University
name: Gintarė Daukšaitė
role: PRINCIPAL_INVESTIGATOR
References: