Exercise on Multiple Sclerosis Patients

October 11, 2019 updated by: Petros Dinas

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Thessaly
      • Tríkala, Thessaly, Greece, 42100
        • FAME Lab, Department of Exercise Science, University of Thessaly

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Exercise with cooling
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.
Behavioral: Exercise with cooling
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
Active Comparator: Exercise without cooling
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.
Behavioral: Exercise without cooling
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Core Temperature
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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)].
Change from baseline to after 40 minutes of continous cycling.
Functional ability test Handgrip
Time Frame: Change from baseline to after 40 minutes of continous cycling.
Handgrip dynamometer was used for the upper body muscle strength evaluation. Both hands was tested.
Change from baseline to after 40 minutes of continous cycling.
Functional ability test 2-minute walk
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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
Change from baseline to after 40 minutes of continous cycling.
Functional ability test 25-Foot Walk (T25-FW)
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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
Change from baseline to after 40 minutes of continous cycling.
Functional ability test five times sit-to-stand test (STS)
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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
Change from baseline to after 40 minutes of continous cycling.
Functional ability test Berg Balance Scale (BBS)
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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.
Change from baseline to after 40 minutes of continous cycling.
Functional ability test level of fatigue severity (FSS)
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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.
Change from baseline to after 40 minutes of continous cycling.
Functional ability test Cognitive function
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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
Change from baseline to after 40 minutes of continous cycling.
Functional ability test level of fatigue impact
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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.
Change from baseline to after 40 minutes of continous cycling.
Functional ability test level of fatigue inventory
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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.
Change from baseline to after 40 minutes of continous cycling.
Functional ability test level of physical fatigue
Time Frame: Change from baseline to after 40 minutes of continous cycling.
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.
Change from baseline to after 40 minutes of continous cycling.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Petros Dinas

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonia Kaltsatou, PhD, FAME Laboratory, Department of Exercise Science, University of Thessaly

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5. Multiple Sclerosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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