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Exercise on Multiple Sclerosis Patients

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Exercise with cooling
Exercise without cooling
Sponsored by
Petros Dinas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Uthoff's phenomenon, Thermosensitivity, Functional capacity, Exercise intolerance

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • FAME Lab, Department of Exercise Science, University of Thessaly

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise with cooling

Exercise without cooling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Core Temperature
The core temperature was measured using a telemetric capsule or (e-Celsius Performance, BodyCap, Caen, France). Temperature at the skin surface was recorded every second at four sites using iBUTTON sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA) [Tsk; 0.3 (chest C arm) C 0.2 (thigh C leg)].
Functional ability test Handgrip
Handgrip dynamometer was used for the upper body muscle strength evaluation. Both hands was tested.
Functional ability test 2-minute walk
The two-minute walk test was applied where all the patients had to cover as far a distance as possible over 2 minutes. All the walking tests are related with the ability to perform independently the activities of daily living
Functional ability test 25-Foot Walk (T25-FW)
The 25-Foot Walk (T25-FW) was used to measure the walking speed. It is a validated test that reflects the patient's mobility and leg function performance
Functional ability test five times sit-to-stand test (STS)
The five times sit-to-stand test (STS) was used as an indicator for lower limb strength, balance and mobility. It has been reported that the STS times are associated with standing and leaning balance and mobility in older people. Slow STS time have been also found to predict subsequent disability, falls and hip fractures
Functional ability test Berg Balance Scale (BBS)
The Berg Balance Scale (BBS) evaluates the performance in specific activities that require balance function. The BBS test lasts approximately 20 minutes and involves common actions (e.g. sit to stand, picking up an object, standing on one leg e.t.c.) necessary for activities of daily living. The BBS is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Functional ability test level of fatigue severity (FSS)
The FSS is a 9-item self-report scale about fatigue of certain activities. Its score includes a 7-point scale from 1 = strongly disagree to 7 = strongly agree. The minimum possible score is nine and the highest is 63. High score indicates severe fatigue. FSS takes approximately eight minutes to complete.
Functional ability test Cognitive function
Cognitive function was assessed with the mini mental state examination (MMSE) questionnaire. MMSE includes tests of orientation, attention, memory, language and visual-spatial skills. The answers in the MMSE are scored as following: 0=incorrect, 1=correct, 6= item administered, participant does not answer and 9= unknown
Functional ability test level of fatigue impact
Level of fatigue was assessed by the Modified Fatigue Impact Scale (MFIS). The MFIS contains the following sections: a) Physical Sub-scale (score 0-36), b) Cognitive Sub-scale (score 0-40) and Psychological Sub-scale (score 0-8). The total MFIS score is 0-84; 0 represents the lower score and 84 represents the higher score.
Functional ability test level of fatigue inventory
Level of fatigue was assessed by the 20-item scale Multidimensional Fatigue Inventory (MFI) questionnaire. The score of MFI is 1-7. The more the fatigue, the higher the score.
Functional ability test level of physical fatigue
Level of fatigue was assessed by the Cognitive and Physical Fatigue in Multiple Sclerosis Scale (CPF-MS). The CPF-MS score is 1-5. The more the fatigue, the higher the score.

Secondary Outcome Measures

Full Information

First Posted
October 8, 2019
Last Updated
October 11, 2019
Sponsor
Petros Dinas
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1. Study Identification

Unique Protocol Identification Number
NCT04125628
Brief Title
Exercise on Multiple Sclerosis Patients
Official Title
Effects of Head and Neck Cooling on Functional Ability and Fatigue of Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Petros Dinas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Uthoff's phenomenon, Thermosensitivity, Functional capacity, Exercise intolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise with cooling
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise without cooling
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise with cooling
Intervention Description
The exercise training session involved head cooling and neck wraps. Participants followed a 40-minute continuous cycling where they 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 condition 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
Intervention Type
Behavioral
Intervention Name(s)
Exercise without cooling
Intervention Description
The exercise session performed without cooling. Participants followed a 40-minute continuous cycling where they 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.
Primary Outcome Measure Information:
Title
Core Temperature
Description
The core temperature was measured using a telemetric capsule or (e-Celsius Performance, BodyCap, Caen, France). Temperature at the skin surface was recorded every second at four sites using iBUTTON sensors (type DS1921 H, Maxim/Dallas Semiconductor Corp., USA) [Tsk; 0.3 (chest C arm) C 0.2 (thigh C leg)].
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test Handgrip
Description
Handgrip dynamometer was used for the upper body muscle strength evaluation. Both hands was tested.
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test 2-minute walk
Description
The two-minute walk test was applied where all the patients had to cover as far a distance as possible over 2 minutes. All the walking tests are related with the ability to perform independently the activities of daily living
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test 25-Foot Walk (T25-FW)
Description
The 25-Foot Walk (T25-FW) was used to measure the walking speed. It is a validated test that reflects the patient's mobility and leg function performance
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test five times sit-to-stand test (STS)
Description
The five times sit-to-stand test (STS) was used as an indicator for lower limb strength, balance and mobility. It has been reported that the STS times are associated with standing and leaning balance and mobility in older people. Slow STS time have been also found to predict subsequent disability, falls and hip fractures
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test Berg Balance Scale (BBS)
Description
The Berg Balance Scale (BBS) evaluates the performance in specific activities that require balance function. The BBS test lasts approximately 20 minutes and involves common actions (e.g. sit to stand, picking up an object, standing on one leg e.t.c.) necessary for activities of daily living. The BBS is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test level of fatigue severity (FSS)
Description
The FSS is a 9-item self-report scale about fatigue of certain activities. Its score includes a 7-point scale from 1 = strongly disagree to 7 = strongly agree. The minimum possible score is nine and the highest is 63. High score indicates severe fatigue. FSS takes approximately eight minutes to complete.
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test Cognitive function
Description
Cognitive function was assessed with the mini mental state examination (MMSE) questionnaire. MMSE includes tests of orientation, attention, memory, language and visual-spatial skills. The answers in the MMSE are scored as following: 0=incorrect, 1=correct, 6= item administered, participant does not answer and 9= unknown
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test level of fatigue impact
Description
Level of fatigue was assessed by the Modified Fatigue Impact Scale (MFIS). The MFIS contains the following sections: a) Physical Sub-scale (score 0-36), b) Cognitive Sub-scale (score 0-40) and Psychological Sub-scale (score 0-8). The total MFIS score is 0-84; 0 represents the lower score and 84 represents the higher score.
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test level of fatigue inventory
Description
Level of fatigue was assessed by the 20-item scale Multidimensional Fatigue Inventory (MFI) questionnaire. The score of MFI is 1-7. The more the fatigue, the higher the score.
Time Frame
Change from baseline to after 40 minutes of continous cycling.
Title
Functional ability test level of physical fatigue
Description
Level of fatigue was assessed by the Cognitive and Physical Fatigue in Multiple Sclerosis Scale (CPF-MS). The CPF-MS score is 1-5. The more the fatigue, the higher the score.
Time Frame
Change from baseline to after 40 minutes of continous cycling.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia Kaltsatou, PhD
Organizational Affiliation
FAME Laboratory, Department of Exercise Science, University of Thessaly
Official's Role
Principal Investigator
Facility Information:
Facility Name
FAME Lab, Department of Exercise Science, University of Thessaly
City
Tríkala
State/Province
Thessaly
ZIP/Postal Code
42100
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
No

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