Effects of Head and Neck Cooling on Functional Ability and Fatigue of Multiple Sclerosis

Petros Dinas1 个研究点分布在 1 个国家目标入组 10 人开始时间: 2019年6月1日最近更新: 2019年10月14日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 10
试验地点: 1
主要终点: Functional ability test five times sit-to-stand test (STS)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Multiple sclerosis (MS) patients are characterized by thermoregulatory failure, known as Uthoff's phenomenon. Precisely, 60-80% of the MS patients present adverse clinical symptoms when their body temperature is increased. Thus, the development of treatment strategies to overcome the thermoregulatory problem in these patients is crucial. Given that cooling has been proposed as an effective method, the aim of this study was to examine whether the application of head cooling therapy during an exercise training session is capable to prevent the core temperature increase and to improve the patient's functional ability and quality of life.

详细描述

Multiple Sclerosis (MS) mostly affects young individuals aged between 20 to 40 years and is the leading cause of morbidity and disability in young. Most of the MS patients experience motor symptoms such as ataxia, tremor, dizziness, limb weakness and vertigo that induce gait difficulty. More precisely, it has been reported that in around 85% of patients diagnosed with MS the gait difficulties are the main problem, which increases the risk for falls. Except for the motor difficulties, MS patients experience multiple physical, cognitive and neurological symptoms that reduce their quality of life. Also, fatigue is another frequent symptom, which is considered among the most disabling symptoms. MS patients 10 years after the onset of the disease become unable to perform housekeeping and employment responsibilities, and as a consequence, the patients experience high depression rates while the suicide incidence is high, varying from 28.6% to 2.5% in these patients. Over the past 15 years a variety of studies have proved that exercise training in patients with chronic diseases, improve their functional capacity and quality of life, and accordingly are capable of performing their daily living activities independently, while it can reduce depression and delay the progression of the disease's symptoms. Nevertheless, MS patients for many years were advised not to participate in exercise training programs because there was a perception that exercise could worsen the disease symptoms due to increased body temperature. Indeed 60-80% of the MS patients present adverse clinical symptoms when their body temperature is increased not only due to physical working but even when immersing in hot water or by exposure to infrared lamps or the sun. Since MS has a severe economic impact as it affects mostly young adults in their most productive years and leads to loss of work capacity and exercise training has the potential to prevent or ameliorate this loss, the need to develop new treatment strategies that could overcome the thermoregulatory problem during exercise is crucial. Therefore, it has been proposed that active precooling is considered an effective treatment for reducing the consequences of induced-heat stress due to exercise. Therefore, this study will examine whether a session of pre-cooling could improve the functional ability of patients with MS.

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: Double (Participant, Care Provider)

入排标准

性别: All
接受健康志愿者: 是

入选标准

•Postmenopausal women (no menses for the last year at least);
•Osteoporosis patients (female): T-score<-2.5 at the femoral neck (or other anatomical site);
•Osteoporosis patients (male): T-score<-2.5 at the femoral neck (or other anatomical site)
•Osteopenia patients (female): T-score<-1.0 at the femoral neck (or other anatomical site);
•Osteopenia patients (male): T-score<-1.0 at the femoral neck (or other anatomical site)
•Patients taking drugs/ supplements for osteoporosis will be accepted in the study after going through a wash-up period

排除标准

•Women with irregular menses (i.e. with no established menopause)
•Patients taking medications for other diseases known to interfere with bone metabolism
•Patients with other chronic diseases (e.g. diabetes)

研究组 & 干预措施

Exercise with cooling

Experimental

Assigned Interventions 10 MS patients (aged 25----50 years) with Expanded Disability Status Scale between 2 to 6.5 have agreed to participate in this study. The exercise training session involved head cooling and neck wraps. The exercise training session consisted of 40 min continuous cycling where the participants performed an incremental sub-maximal exercise protocol beginning at 45 W, increasing 10 W every 10 min for a total of four stages on a semirecumbent cycle ergometer in a 20oC room. Before and after the completion of the session each participant performed a variety of functional ability tests. The evaluation of the core temperature and the assessment of the patient's quality of life also was performed.

干预措施: Exercise with cooling (Behavioral)

Exercise without cooling

Active Comparator

10 MS patients (aged 25----50 years) with Expanded Disability Status Scale between 2 to 6.5 have agreed to participate in this study. The exercise session performed without cooling. The exercise training session consisted of 40 min continuous cycling where the participants performed an incremental sub-maximal exercise protocol beginning at 45 W, increasing 10 W every 10 min for a total of four stages on a semirecumbent cycle ergometer in a 20oC room. Before and after the completion of the session each participant performed a variety of functional ability tests. The evaluation of the core temperature and the assessment of the patient's quality of life also was performed.

干预措施: Exercise without cooling (Behavioral)