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临床试验/NCT06370403
NCT06370403已完成不适用

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

Lithuanian Sports University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2014年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Body fat (%)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
None

盲法说明

The researchers who analyzed the venous blood samples were blinded.

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 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

结局指标

主要结局

Body fat (%)

时间窗: Every time in all conditions at the baseline

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

Body free fat mass (kg)

时间窗: Every time in all conditions at the baseline

Body free fat mass (kg) was evaluated using Tanita Body Composition Analyzer (Japan).

Body mass index (kg/m2)

时间窗: 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.

Change in muscle temperature (°C)

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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)

时间窗: Every time in all conditions at the baseline

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

Change in involuntary torque (Nm)

时间窗: 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)

时间窗: 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)

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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)

时间窗: 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

时间窗: 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 (±).

次要结局

  • Height (m)(Every time in all conditions at the baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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