Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Phase: NA
Conditions: Multiple Sclerosis
Sponsor: Kamila Řasová

Official Title: Preventive Complex Program for Newly Diagnosed 
People With Multiple Sclerosis 
Brief Title: Preventive Program in Multiple Sclerosis 
Unique Protocol ID: EK-VP/25/0/2014 
Identifiers: NCT04667130 
Date: 1.9. 2017  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Methods 
 
1.1. Study design 
The study Preventive Complex Program for Newly Diagnosed 
People With Multiple Sclerosis (NCT04355663) was realized between October 
2017 and October 2019. 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. 
 
1.2. Participants 
The study included 22 newly diagnosed MS patients who met the study entry 
criteria (definitively confirmed diagnosis of MS, maximum similarity of clinical 
manifestations and disease course, stability of the clinical condition over the last 
3 months, Expanded Disability Status Scale (EDSS) ≤ 6, no changes in 
pharmacotherapy. The evaluation of the entry criteria was performed by an 
independent neurologist of the MS Center of the Neurological Clinic of the FNKV 
in Prague. All subjects signed an informed consent form approved by the Ethics 
Committee of Kralovske Vinohrady University Hospital in Prague (full trial 
protocol EK-VP/25/0/2014 is available there). 
 
1.3. Examination  
All 22 participants were examined three times - before the start of the 
physiotherapy program, immediately after its end and six months apart. The 
effect on physical fitness (activity)  (spiroregometric examination), fatigue 
(Modify Fatigue Impact Scale, Fatigue scale for motor and cognitive functions), 
depression (Beck's scale for assessing depression), acceptance of MS (Inventory 
of Adoption of Multiple Sclerosis), quality of life (Scale life satisfaction) and 
selected neurohormones (cortisol, cortison, 7β-OH-DHEA, 7-oxo-DHEA, DHEA). 
Inclusion Criteria: 
• definite MS 

• stable clinical status in the preceding 3 months 
• imuno-modulatory treatment for at least two years (including glatiramer 
acetate, interferon beta-1a, 1b, mitoxantrone, fingolimod, natulizumab) 
• Expanded Disability Status Scale (EDSS)≤6 
• predominant motor impartment 
• six months or more without any physiotherapy 
• ability to undergo ambulatory physiotherapy 
Exlusion criteria: 
• other neurological disease or conditions disabling movement 
1.3.1.  
Basic characteristics 
The study collected some sociodemographic data, disease and treatment data: 
age, gender, height, weight, Body Mass Index (BMI), disease duration, type of 
disease, current pharmacological treatment, EDSS. 
1.3.2.  
Spiroergometric parameters  
The following parameters were measured during spiroergometric examination: 
ventilation capacity - Forced vital capacity (FVC), 
metabolic utilization (maximal muscle performance Watt kg-1  = Rmax), maximal 
oxygen uptake VO2 kg-1 = VO2max.kg-1), maximal oxygen pulse VO2 HR-1 kg-1 = 
VO2max.TF-1), relative ventilation (VEmax.kg-1), and overall fitness compared 
to the population of the same age in percent. 
It was used for P / O (flow-volume) spirometry automatic breathing gas analyzer 
Kardiospirox-W1. Instrumentation was used for spiroergometry on a bicycle 
ergometer, Vita maxima method: bicycle ergometer Sana Bike 350 GE, electrodes 
for restless conditions Cardio-Vac type Vacuboy D, monitor for continuous 
monitoring of exercise electrocardiogram DELL REV A02, USA, monitor for 
continuous monitoring of spiroergometric values Benq FP 72E, Taiwan, mercury 
tonometer Sphygmomanometer Global 660, automatic respiratory gas analyzer 
Kardiospirox-W1. 
 
 
 

1.3.3.  
Endocrine parameters  
A blinded assessor (unaware of the intervention assigned to the assessed 
participant) examined primary and secondary outcomes immediately before the 
beginning (Pre-assessment), immediately after (Post-assessment) and 8 weeks 
after the cessation of the two months’ PT program (Washout-assessment).  
The levels of serum hormones were assessed in continuous-flow left ventricular 
assist device (CF-LVAD) recipients between 7 to 8 a.m. in the morning before 
lumbar drainage test. Samples were collected in plastic tubes, frozen and stored 
at -79 °C. Levels of cortisol, cortisone, 7α-OH-DHEA, 7β-OH-DHEA, 7-oxo-DHEA, 
DHEA were measured by LC-MS/MS method described in Sosvorova et al., 2015.  
1.3.4.  
Questionnaires 
The study monitored fatigue, depression, acceptance of MS and quality of life 
using a questionnaire survey. The following questionnaires were used to assess 
the degree of fatigue: 
1) 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, which represents very frequent fatigue in the person. (Ritvo et. 
al., 1997). 
2) 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). Two subscales (mental and 
physical fatigue) can be made. Items included in the subscale mental are 1-4-7-8-
11-13-15-17-18-20 and items included in the subscale physical are 2-3-5-6-9-
10-12-14-16-19. (Penner et al.,2009). 
3) Questionnaires were used to assess the mental state and acceptance of MS:  
 The Satisfaction With Life 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). (Diener et al., 1985). 
4) Multiple Sclerosis Acceptance Questionnaire focuses on the method of 
adaptation to the diagnosis of MS. 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) (Ferenbach et al., 2011). 
5) Beck Depression Inventory Score. This 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. (Beck et al.,1961). 
 
1.4 Therapy  
The program included information on the possibilities of physiotherapy 
(seminar, brochure), influencing fatigue (recommending lifestyle changes, 
learning 
movement 
strategies, 
regular 
controlled 
aerobic 
training), 
psychotherapy, treatment of psychosomatic, somatovisceral and visceromotor 
functional disorders using computer kinesiology, and individual therapy for 
neurophysiological basis Motor programs activating therapy. 
1) Providing information about the possibilities of physiotherapy (seminar, 
brochure, Řasová et. Al., 2017). At the beginning of the program, an introductory 
lecture was organized, in which participants were introduced to the possibilities 
of physiotherapy in the treatment of multiple sclerosis (Řasová et. Al., 2017). We 
focused 
on 
fatigue 
management 
- 
recommending 
lifestyle 
changes. 
2) Individual therapy dealt with the treatment of psychosomatic, somatovisceral 
and visceromorotic functional disorders by reflexively poor connection through 
the locomotor system using computer kinesiology. The patients received a total 
of four individual therapies. This therapy was performed by a trained 
physiotherapist by manual contact according to the usual procedures in the field 

of rehabilitation and physical medicine, ie it examines the range of motion in 
individual limb segments, examines the spine in the basic planes, examines reflex 
changes in soft tissues and actively searches for trigger points. All tests are 
evaluated according to the required criteria and the obtained data are entered 
into special software. EIS Computer Kinesiology Profi The Start Complex 
compares the obtained data with the reflection contexts of Western and Eastern 
medicine. EIS Computer Kinesiology Profi Complex Start software processes 
information on feedback relationships of "horizontal" functions, ie segmental 
(meaning spinal segments, reflex relationships to visceral organs and endocrine 
glands) as well as "vertical relationships" (myofascial chains and chaining of 
functional disorders, muscle pathways from classical acupuncture). 
EIS Computer Kinesiology Profi Start Complex in therapy uses:  
• kinesiological analysis algorithm  
• algorithm for searching for reflex changes in soft tissues  
• currently individually adequate selection of exercises (patient education for 
homework) (Jandová et. Al., 2013). 
3) Group psychotherapy:  The program participants completed a total of six 
group psychotherapies. Psychotherapy used psychological means such as words, 
conversation, nonverbal behavior, working with emotions and awareness, 
creating a therapeutic relationship. During group psychotherapy, self-knowledge 
expands and deepens and leads to a reduction in self-destructive behavior, 
effective management of problems, conflicts and life tasks. It helps patients 
better adapt to life situations, gain insight (understanding the context and 
unconscious motives), gain new information, learn to solve their problems 
effectively (Schubertova, 2013). The main goal of psychotherapy was to accept a 
new life situation, change attitudes, improve self-awareness, persuade to take an 
active approach to treatment, create a new healthier lifestyle with respect for 
illness and oneself, and thus to increase the overall quality of life. 
4) A series of three workshops in which participants became actively introduced 
to how they can control momentum using Motorized Therapy Activating 
Programs (MPAT).  
In MPAT therapy, partial motor functions are induced, which mature during 
postural development. Motor programs that can only be activated at the 

subconscious level are activated. Postural stabilization is induced and supported 
in the sagittal plane, stabilizing functions while sitting, when getting up, standing 
and stepping. The whole body is activated, there is an interaction between the 
postural system, the upright system and the system of phasic movements. During 
therapy, the joints of the whole body are functionally centered, the spine is 
straightened and the dynamic reaction of the whole body is activated (Řasová et. 
Al., 2017). The workshop was attended by all participants in the study at once. 
The elements of sensorimotor learning and motor control were individually 
shown to everyone and the motor program was activated (during the first 
workshop the motor program for sitting, the second for standing and the third 
step). The programs were individually activated during the two-hour workshop 
(the workshop was also attended by eight postgraduate students, thanks to 
whom it was possible to correct the activated postural positions for all workshop 
participants). 
 
1.5.  
Primary outcome measures:  
Questionnaires:  Modified Fatigue Impact Scale, The Fatigue scale for motor and 
cognitive functions, The Satisfaction With Life Scale, Multiple Sclerosis Acceptance 
Questionnaire, Beck Depression Inventory Score.  
 
Secondary outcome measures:  
Spiroergometric parameters - ventilation capacity - Forced vital capacity (FVC), 
metabolic utilization (maximal muscle performance Watt kg-1  = Rmax), maximal 
oxygen uptake (VO2 kg-1 = VO2max.kg-1), maximal oxygen pulse (VO2 HR-1 kg-1 = 
VO2max.TF-1), relative ventilation (VEmax.kg-1).  
Endocrine parameters - levels of cortisol, cortisone, 7β-OH-DHEA, 7-oxo-DHEA, 
DHEA. 
 
1.6. 
Statistical analysis:  
All measured spiroergometric values as well as all the measured spirometric 
values were compared with the Czech population norm. (Seliger V, Bartůněk Z, 

Roth Z. Physical fitness of the Czech population aged from 12 to 55 years . Praha: 
Karolinum, 1977 (in Czech).