An interventional study of Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis in Multiple Sclerosis, sponsored by Kamila Řasová. Completed at 1 site in Czechia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-02-01.
Sponsored by Kamila Řasová · Not applicable, Interventional, and Prevention
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.
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).
3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.
This study's enrollment of 17 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →This is the only study on the registry with Kamila Řasová as lead sponsor.
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Exclusion Criteria:
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
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.
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).
Time frame: 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).
Time frame: 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) .
Time frame: 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.
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Ventilation capacity
Forced vital capacity = FVC \[ l \]
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Metabolic utilization
maximal muscle performance = Rmax \[ Watt kg-1 \]
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Maximal oxygen uptake
VO2 kg-1 \[ VO2max.kg-1 \]
Time frame: 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 \[ VO2max.TF-1 \]
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Relative ventilation
\[ VEmax.kg-1 \]
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Cortisol
levels of cortisol \[ ng/mL \]
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Cortizone
levels of cortisone\[ ng/mL \]
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Dehydroepiandrosterone (DHEA)
levels of DHEA \[ ng/mL \]
Time frame: 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 \[ ng/mL \]
Time frame: 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 \[ ng/mL \]
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Questionnaires - Modified Fatigue Impact Scale
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.
Time frame: change after six months of the program and after next six moths without therapy is being assessed
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