Preventive Program in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04667130
• Other study ID #: EK-VP/25/0/2014
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: January 2021
• Source: Charles University, Czech Republic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
Czechia	Kamila Rasová	Praha

Sponsors (1)

Lead Sponsor	Collaborator
Kamila Rasová

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	change after six months of the program and after next six moths without therapy is being assessed
Primary	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
Primary	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
Primary	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
Primary	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	Ventilation capacity	Forced vital capacity = FVC [ l ]	change after six months of the program and after next six moths without therapy is being assessed
Secondary	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
Secondary	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
Secondary	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
Secondary	Relative ventilation	[ VEmax.kg-1 ]	change after six months of the program and after next six moths without therapy is being assessed
Secondary	Cortisol	levels of cortisol [ ng/mL ]	change after six months of the program and after next six moths without therapy is being assessed
Secondary	Cortizone	levels of cortisone[ ng/mL ]	change after six months of the program and after next six moths without therapy is being assessed
Secondary	Dehydroepiandrosterone (DHEA)	levels of DHEA [ ng/mL ]	change after six months of the program and after next six moths without therapy is being assessed
Secondary	7ß-hydroxydehydroepiandrosterone (7ß-OH-DHEA )	levels of 7ß-OH-DHEA [ ng/mL ]	change after six months of the program and after next six moths without therapy is being assessed
Secondary	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