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

NCT06370403 | Completed

• 1 other identifier: LithuanianSportsU-21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple sclerosis; Cooling; Heating; Fatigue; Exercise

Outcome Measures

Primary Outcomes (17)

• Body weight (kg)

  Body weight (kg) was evaluated using Tanita Body Composition Analyzer (Japan).

  Every time in all conditions at the baseline

• Body fat (%)

  Body fat (%) was assessed using Tanita Body Composition Analyzer (Japan).

  Every time in all conditions at the baseline

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Σ indicates the mean that was calculated considering the algebraic symbols (±).

  Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

• 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 Σ \| \| indicate the mean that was calculated without considering the algebraic symbols (±).

  Baseline, up to 60 minutes, up to 120 minutes, after 180minutes

Secondary Outcomes (1)

• Height (m)

  Every time in all conditions at the baseline

Study Arms (2)

Cooling of the head and neck in multiple sclerosis and healthy subjects

EXPERIMENTAL

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).

Other: Cooling of the head and neck

Heating of the head and neck in multiple sclerosis and healthy subjects

EXPERIMENTAL

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).

Other: Heating of the head and neck

Interventions

Cooling of the head and neck OTHER

Cooling of the head and neck at 18°C next to the head and neck skin in multiple sclerosis and healthy subjects

Cooling of the head and neck in multiple sclerosis and healthy subjects

Heating of the head and neck OTHER

Heating of the head and neck at 43 ± 1°C next to the head and neck skin in multiple sclerosis

Heating of the head and neck in multiple sclerosis and healthy subjects

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lithuanian Sports University: lead

Study Sites (1)

Lithuanian Sports University

Kaunas, LT 44221, Lithuania

Location

MeSH Terms

Conditions

Multiple Sclerosis; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Gintarė Daukšaitė

  Lithuanian Sports University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The researchers who analyzed the venous blood samples were blinded.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 17, 2024
• Study Start: February 4, 2014
• Primary Completion: March 1, 2016
• Study Completion: January 8, 2017
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

LI (1)