Multiple Sclerosis
Conditions
Keywords
Preventive program, Multiple Sclerosis, Rehabilitation
Brief summary
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
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).
Interventions
BEHAVIORALPreventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
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.
Sponsors
Kamila Řasová
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Questionnaires - Beck Depression Inventory Score | change after six months of the program and after next six moths without therapy is being assessed | 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. |
| Questionnaires - The Fatigue scale for motor and cognitive functions | change after six months of the program and after next six moths without therapy is being assessed | 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). |
| Questionnaires - The Satisfaction With Life Scale | change after six months of the program and after next six moths without therapy is being assessed | 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). |
| Questionnaires - Multiple Sclerosis Acceptance Questionnaire | change after six months of the program and after next six moths without therapy is being assessed | 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) . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximal oxygen pulse | change after six months of the program and after next six moths without therapy is being assessed | VO2 HR-1 kg-1 \[ VO2max.TF-1 \] |
| Relative ventilation | change after six months of the program and after next six moths without therapy is being assessed | \[ VEmax.kg-1 \] |
| Cortisol | change after six months of the program and after next six moths without therapy is being assessed | levels of cortisol \[ ng/mL \] |
| Dehydroepiandrosterone (DHEA) | change after six months of the program and after next six moths without therapy is being assessed | levels of DHEA \[ ng/mL \] |
| 7β-hydroxydehydroepiandrosterone (7β-OH-DHEA ) | change after six months of the program and after next six moths without therapy is being assessed | levels of 7β-OH-DHEA \[ ng/mL \] |
| 7-oxo dehydroepiandrosterone (7-oxo-DHEA ) | change after six months of the program and after next six moths without therapy is being assessed | levels of 7-oxo-DHEA \[ ng/mL \] |
| Cortizone | change after six months of the program and after next six moths without therapy is being assessed | levels of cortisone\[ ng/mL \] |
| Ventilation capacity | change after six months of the program and after next six moths without therapy is being assessed | Forced vital capacity = FVC \[ l \] |
| Metabolic utilization | change after six months of the program and after next six moths without therapy is being assessed | maximal muscle performance = Rmax \[ Watt kg-1 \] |
| Maximal oxygen uptake | change after six months of the program and after next six moths without therapy is being assessed | VO2 kg-1 \[ VO2max.kg-1 \] |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaires - Modified Fatigue Impact Scale | change after six months of the program and after next six moths without therapy is being assessed | This scale consists of 21 statements that describe how often fatigue has affected a person during last four weeks. Each statement is ranged from 0 (never) to 4 (almost, always). The maximum value of the scale is 84. |
Countries
Czechia
Outcome results
None listed