The Impact of Exercise Training on Living Quality in Multiple Sclerosis Individuals
Condition: Multiple Sclerosis; Fatigue; Mental Status Change; Physical Disability; Physical Activity; Mental Impairment; Quality of Life; Disabilities Psychological; Disability Physical; Pain; Energy Supply; Deficiency; Motivation
MeSH terms: Multiple Sclerosis; Sclerosis; Fatigue
Study type: Interventional

Summary: 
      The most common symptom displayed in patients with multiple sclerosis (MS) is a pronounced
      sense of fatigue that can have negative effect on functional ability and quality of life
      (QOL).

      An important goal of researchers and clinicians involves improving the QOL of individuals
      with MS, and the exercise therapy represents potentially modifiable behavior that positively
      impacts on pathogenesis of MS and thus the QOL.

      However, the main barrier for its application is low motivational level that MS patients
      experience due to fatigue with adjacent reduced exercise tolerability and mobility, and
      muscle weakness. Getting individuals with MS motivated to engage in continuous physical
      activity may be particularly difficult and challenging, especially those with severe
      disability or Expanded Disability Status Scale (EDSS 6-8).

      Till now, researchers have focused their attention mainly on the moderate or vigorous
      intensity of exercise and on cardiorespiratory training in MS patients to achieve
      improvements in daily life quality, less indicating the exercise content, and most
      importantly, breathing exercises.

      In addition, it is investigators intention to make exercise for MS patients more applicable
      and accessible, motivational and easier, but most important, productive.

      Investigators think that MS patients experience more stress with aerobic exercise or moderate
      to high intensity programme exercise, and can hardly keep continuum including endurance
      exercise, or treadmill.

      Hypothesis:

      Investigators hypothesis is that 4-weeks of continuous low demanding or mild exercise
      programme with specific content and an accent on breathing exercise can attenuate primary
      fatigue in MS patients, especially in those with more severe disability or EDSS from 6-8, and
      provide maintenance of exercise motivation. Investigators also propose that important
      assistant factor for final goal achievement is social and mental support of the exercise
      group (EDSS from 0-8) led by a physiotherapist. This will help to maintain exercise
      motivation and finally make better psychophysical functioning, and thus better QOL.
    

Detailed description: 
      This study will include individuals with multiple sclerosis including all MS types with EDSS
      from 0-8, who will be practicing at the Multiple Sclerosis Association in Rijeka for a period
      of 1 month, 2 times a week for 60 minutes per exercise (total 8h).

      Participants will be randomly selected into 2 groups: ambulatory and non-ambulatory
      (wheelchair) MS individuals that will exercise - group (MSE), with related control group
      (ambulatory and non-ambulatory (wheelchair) individuals who will not exercise) (MSC). In
      addition, a group of healthy control subjects without MS (HC) will be evaluated.

      Ambulatory and non-ambulatory group of individuals will exercise under the guidance of a
      physiotherapist. Exercise will be carried out sitting on the chairs for all participants,
      regardless of whether participants are able to walk or not. The practitioner of exercises
      will first demonstrate and explain each exercise. Participants will be emphasized during
      exercise to stop exercising if there is tiredness, weakness, pain or any other discomfort.

      At the beginning of each exercise session, exercise will be initiated by warming muscles and
      breathing exercises. Therapeutic and abdominal breathing exercises with extended exhalation
      will be also conducted. Then follow the exercises of stretching and increasing the movement
      range of the upper limbs. Participants will work with dumbbells and elastic straps to
      strengthen the muscles of the upper extremities. In the end of training session, there will
      be devoted to stretching of the muscle groups involved during exercise.

      Each participant involved in the study will undergo the examination through several
      functional tests at the beginning and up to 4-weeks of the study or exercise, including
      post-exercise questionnaire for motivation analysis:

        1. Assessment of pain level using a "Visual Analogue Scale" for pain (VAS). It is a
           psychometric response scale or a measurement instrument for subjective characteristics
           that cannot be directly measured. Here, the participants state their degree of agreement
           with the facial expression shown with the description of the pain in words, including
           the appropriate number below the image. VAS for pain is 5 units long, 0 to 5 (0-no pain
           and 5-hardest possible pain). Since every patient experiences a pain differently, this
           simple test can evaluate and make it visible.

        2. An assessment of the functional independence of daily activities and severity of
           individuals disability using the "Barthel Index". This test measures the level of
           independent daily functioning such as feeding, bathing, combing, controlling the bowel,
           bladder control, transferring from the chair, and mobility and climbing on stairs. This
           determines the level of disability. The test point to the need for help and care. Score
           range from 0-100.

        3. Evaluation of Quality of Life using the abbreviated version of the "36-Item Short Form
           Survey" (36-SF). It contains 36 questions including 8 subclasses: physical function,
           role of constraints due to physical problems, physical pain, general health perception,
           energy level, social function, the role of limitations due to psychological problems and
           general mental health. The test time is 10 minutes. The scoring system for the SF-36 is
           relatively complex and is obtained by summing the results for each sub-base separately.
           Two summaries can be derived from physical subclasses and psychic subclasses. SF-36 is
           one of "Multiple Sclerosis Quality of Life Inventory" (MSQLI) and Multiple Sclerosis
           Quality of Life-54(MSQOL-54) .

        4. Grip strength testing with hand dynamometer. It will be measured by hydraulic
           dynamometer (Jamar, Patterson Medical, USA). The dynamometer handle will be set at
           position number 2. Measurements will be performed on the dominant and non-dominant hand
           in the neutral position of the wrist and the elbow joint at 90 º. Each gripe must be
           maximal (3 in a row) for the mean value.

        5. Assessment of cognitive ability using the "Standardized Mini-Mental State Examination"
           test (SMMSE). SMMSE lasts only 5-10 minutes and is therefore a convenient test to use on
           multiple occasions.

           SMMSE is effective as a screening test for patients with less cognitive abilities than
           those without it. In addition, with the help of this test, it is possible to measure
           changes in the cognitive status that may have been corrected by the intervention.

        6. Fatigue estimation using the "Modified Fatigue Impact Scale" (MFIS). It is a modified
           form of the Fatigue Impact Scale based on data obtained from interviews with MS patients
           on how tiredness affects their lives. This test gives an assessment of tiredness effects
           on physical, cognitive and psychosocial functioning and can therefore be treated as 3
           separate categories. In full-time MFIS consists of 21 questions. The time to complete is
           5-10 minutes and the examinee can solve the test without the help of an interviewer. The
           total points are obtained by summing all the answers or the additions are made
           separately by the mentioned categories.

        7. Questionnaire upon completion of exercise. The final questionnaire will analyse whether
           the participants really felt health change after exercise cycle and motivated them in a
           group under the guidance of a physiotherapist to continue self-exercising at home.

      Each participant will be familiar with the research protocol to be implemented in accordance
      with the Code of Ethics and respecting the principles of the Patient Rights. The investigator
      will explain the use of the tests. Participants will confirm their participation by signing
      their consent. Participants voluntarily involved in this research will be provided oral and
      written consent with the explanation of the possibility of giving up at any time during this
      study without consequences for their further treatment, guaranteed discretion and anonymity
      of the obtained data.

      Statistical data processing:

      The results of the research will be statistically analyzed using a computer program of
      Version 13 (Sigma Plot Scientific Graphing System, v13.0). Statistical significance will be
      calculated by non-parametric test for dependent samples and parametric test for dependent
      samples in cases of normal data distribution. Data will be expressed as mean value ± standard
      error or as a central value of the median value range. The correlation of the observed
      changes will be investigated by Spearman's correlation for nonparametric data. Significant
      statistical changes will be considered at p <0.05.
    

Intervention name(s): Exercise training
Intervention type(s): Behavioral
Intervention description(s): Exercise programme includes breathing and upper limbs exercises.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly selected into 2 groups: ambulatory and non-ambulatory (wheelchair) MS individuals that will exercise - group (MSE), with related control group (ambulatory and non-ambulatory (wheelchair) individuals who will not exercise) (MSC). In addition, a group of healthy control subjects without MS (HC) will be evaluated.
Ambulatory and non-ambulatory group of individuals will exercise under the guidance of a physiotherapist.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Quality of Life; Fatigue; Physical Disability; Disabilities Psychological; Pain; Motivation; Multiple sclerosis