Exercise on Multiple Sclerosis Patients

NCT04125628 | Completed

• 1 other identifier: 5. Multiple Sclerosis
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Uthoff's phenomenon; Thermosensitivity; Functional capacity; Exercise intolerance

Outcome Measures

Primary Outcomes (11)

• 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) \[Tsk; 0.3 (chest C arm) C 0.2 (thigh C leg)\].

  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.

  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

  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

  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

  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.

  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.

  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

  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.

  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.

  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.

  Change from baseline to after 40 minutes of continous cycling.

Study Arms (2)

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.

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.

Behavioral: Exercise without cooling

Interventions

Exercise with cooling BEHAVIORAL

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 with cooling

Exercise without cooling BEHAVIORAL

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.

Exercise without cooling

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Petros Dinas: lead

Study Sites (1)

FAME Lab, Department of Exercise Science, University of Thessaly

Trikala, Thessaly, 42100, Greece

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Exercise

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Antonia Kaltsatou, PhD

  FAME Laboratory, Department of Exercise Science, University of Thessaly

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Researcher in human physiology

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 14, 2019
• Study Start: June 1, 2019
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)