Clinical trial NCT04125628: Exercise on Multiple Sclerosis Patients
Official title: Effects of Head and Neck Cooling on Functional Ability and Fatigue of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Uthoff's phenomenon
Thermosensitivity
Functional capacity
Exercise intolerance
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Core Temperature
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test Handgrip
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test 2-minute walk
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test 25-Foot Walk (T25-FW)
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test five times sit-to-stand test (STS)
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test Berg Balance Scale (BBS)
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test level of fatigue severity (FSS)
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test Cognitive function
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test level of fatigue impact
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test level of fatigue inventory
timeFrame: Change from baseline to after 40 minutes of continous cycling.
measure: Functional ability test level of physical fatigue
timeFrame: Change from baseline to after 40 minutes of continous cycling.
Secondary outcomes:
Other outcomes:
Locations:
city: Tríkala
country: Greece
facility: FAME Lab, Department of Exercise Science, University of Thessaly
state: Thessaly
Study officials:
affiliation: FAME Laboratory, Department of Exercise Science, University of Thessaly
name: Antonia Kaltsatou, PhD
role: PRINCIPAL_INVESTIGATOR
References: