Multiple SclerosisNCT04125628
Exercise on Multiple Sclerosis Patients
A study testing Exercise with cooling and Exercise without cooling in people with Multiple Sclerosis, run by Petros Dinas at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Exercise with cooling and Exercise without cooling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2019to 25 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Greece1 site
FAME Lab, Department of Exercise Science, University of Thessaly
Trikala, Thessaly, 42100
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Exercise with cooling, Exercise without cooling
- Keywords
- Uthoff's phenomenon, Thermosensitivity, Functional capacity, Exercise intolerance
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise with coolingBehavioural
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
Exercise without coolingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Exercise with cooling |
| 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. Receives: Behavioral: Exercise without cooling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)].
Measured: Change from baseline to after 40 minutes of continous cycling.
Functional ability test Handgrip
Handgrip dynamometer was used for the upper body muscle strength evaluation. Both hands was tested.
Measured: Change from baseline to after 40 minutes of continous cycling.
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
Measured: Change from baseline to after 40 minutes of continous cycling.
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
Measured: Change from baseline to after 40 minutes of continous cycling.
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
Measured: Change from baseline to after 40 minutes of continous cycling.
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.
Measured: Change from baseline to after 40 minutes of continous cycling.
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.
Measured: Change from baseline to after 40 minutes of continous cycling.
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
Measured: Change from baseline to after 40 minutes of continous cycling.
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.
Measured: Change from baseline to after 40 minutes of continous cycling.
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.
Measured: Change from baseline to after 40 minutes of continous cycling.
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.
Measured: Change from baseline to after 40 minutes of continous cycling.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Jun 2019
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petros Dinas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Petros Dinas, University of Thessaly
- Investigators
- Antonia Kaltsatou, PhD, Principal investigator, FAME Laboratory, Department of Exercise Science, University of Thessaly
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125628
- Sponsor's protocol ID
- 5. Multiple Sclerosis
- Status last verified
- Oct 2019
- First submitted
- 8 Oct 2019
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Head and Neck Cooling on Functional Ability and Fatigue of Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04125628
- Acronym / sponsor ID
- 5. Multiple Sclerosis
- Conditions
- Multiple Sclerosis
- Keywords
- Uthoff's phenomenon, Thermosensitivity, Functional capacity, Exercise intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Petros DinasUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 14 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise with cooling | Experimental | Behavioral: Exercise with coolingAssigned 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. |
| Exercise without cooling | Active comparator | Behavioral: Exercise without cooling10 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise with coolingThe 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 | Behavioural | Exercise with cooling |
| Exercise without coolingThe 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. | Behavioural | Exercise without cooling |
Primary outcome
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)].
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.
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
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
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
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.
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.
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia Kaltsatou, PhD principal investigator
FAME Laboratory, Department of Exercise Science, University of Thessaly
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise with cooling and Exercise without cooling in people with Multiple Sclerosis, run by Petros Dinas at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core Temperature (time frame: Change from baseline to after 40 minutes of continous cycling.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2019.