Preventive Program in Multiple Sclerosis

Study Overview
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Brief Summary
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This study monitor the immediate and persistent impact of a preventive complex six-month program specifically developed for newly diagnosed people with multiple sclerosis on fatigue, mental and physical fitness, and quality of life. The study determined whether changes in clinical function are related to changes in neurohormones, and whether the effect of therapy is dependent on the active approach of study participants.

Detailed Description
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The patients who were newly diagnosed with MS underwent a six-month preventive comprehensive program, which included individual physiotherapy focused on the treatment of functional disorders of the loco-motor system and therapy on a neurophysiological basis, group psychotherapy and controlled aerobic training. The participants were examined three times - before the start of the physiotherapy program, immediately after its completion and six months apart. Influence on physical fitness (spiroergometric examination), fatigue (Modify Fatigue Impact Scale, fatigue scale for motor and cognitive functions), depression (Beck scale for evaluation of depression), admission of disease RS (Inventory of admission of multiple sclerosis, quality of life) life and selected neurohormones (dehydroepiandrosterone-DHEA, dehydroepiandrosterone sulphate - DHEAS, cortisol).

Official Title
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Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Behavioral: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: definite MS stable clinical status in the preceding 3 months imumnomodulatory treatment for at least two years (including glatiramer acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natalizumab) Expanded Disability Status Scale (EDSS)≤6 predominant motor impartment six months or more without any physiotherapy ability to undergo ambulatory physiotherapy Exclusion Criteria: other neurological disease or conditions disabling movement

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis<br>Providing information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise | Behavioral: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis<br>* Preventive program included informations of the possibilities of physiotherapy in the treatment of multiple sclerosis focused on fatigue management - recommending lifestyle changes. Program included a the treatment of psychosomatic, viscerosomatic functional disorders by reflexively poor connection through the locomotor system using computer kinesiology, psychotherapy, manual therapy - where patients are corrected into a postural position and the joints are functionally centred, and aerobic exercise to influence fatigue and improve the performance of the cardiovascular system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires - The Fatigue scale for motor and cognitive functions | FSMC - is an assessment of MS-related cognitive and motor fatigue. A Likert-type 5-point scale (ranging from 'does not apply at all' to 'applies completely') produces a score between 1 and 5 for each scored question. Thus minimum value is 20 (no fatigue at all) and maximum value is 100 (severest grade of fatigue). | change after six months of the program and after next six moths without therapy is being assessed | 
| Questionnaires - The Satisfaction With Life Scale | The scale measures the current level of satisfaction with one's own life. Investigators express the extent to which they agree or disagree with the five statements. The rating scale contains 7 points (1- strongly disagree and 7 - strongly agree). The maximum number of points on the scale is 35 (maximum satisfaction with your life) and the minimum number of points is 5 (dissatisfaction with your life). | change after six months of the program and after next six moths without therapy is being assessed | 
| Questionnaires - Multiple Sclerosis Acceptance Questionnaire | This questionnaire consists of 20 statements that relate to the lives of patients with MS. The rating scale has seven points (1- never pays to 7 - always pays). The minimum value is 20 (minimum adaptation to the diagnosis of MS for a large limitation of the normal life of MS) and the maximum value is 140 points (maximum adaptation to the diagnosis of MS - without the limitation of the normal life of MS) . | change after six months of the program and after next six moths without therapy is being assessed | 
| Questionnaires - Beck Depression Inventory Score | questionnaire is divided into thirteen categories and patients select a statement in each category which best fits their current feelings on the scale ranged from 0 (the best feelings) to 3 (the worst feelings). The maximum value of the total scale is 39 and shows the worst feeling of the person. | change after six months of the program and after next six moths without therapy is being assessed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation capacity | Forced vital capacity = FVC [ l ] | change after six months of the program and after next six moths without therapy is being assessed | 
| Metabolic utilization | maximal muscle performance = Rmax [ Watt kg-1 ] | change after six months of the program and after next six moths without therapy is being assessed | 
| Maximal oxygen uptake | VO2 kg-1 [ VO2max.kg-1 ] | change after six months of the program and after next six moths without therapy is being assessed | 
| Maximal oxygen pulse | VO2 HR-1 kg-1 [ VO2max.TF-1 ] | change after six months of the program and after next six moths without therapy is being assessed | 
| Relative ventilation | [ VEmax.kg-1 ] | change after six months of the program and after next six moths without therapy is being assessed | 
| Cortisol | levels of cortisol [ ng/mL ] | change after six months of the program and after next six moths without therapy is being assessed | 
| Cortizone | levels of cortisone[ ng/mL ] | change after six months of the program and after next six moths without therapy is being assessed | 
| Dehydroepiandrosterone (DHEA) | levels of DHEA [ ng/mL ] | change after six months of the program and after next six moths without therapy is being assessed | 
| 7β-hydroxydehydroepiandrosterone (7β-OH-DHEA ) | levels of 7β-OH-DHEA [ ng/mL ] | change after six months of the program and after next six moths without therapy is being assessed | 
| 7-oxo dehydroepiandrosterone (7-oxo-DHEA ) | levels of 7-oxo-DHEA [ ng/mL ] | change after six months of the program and after next six moths without therapy is being assessed | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Preventive program, Multiple Sclerosis, Rehabilitation