Preventive Program in Multiple Sclerosis

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Behavioral: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

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).

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Praha, Czechia, 128 00
    • Kamila Řasová

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kamila Řasová
• Investigators: Principal Investigator: Kamila Řasová, Ph.D., Third Faculty of Medicine Charles University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): October 1, 2019
• Study Completion (Actual): October 1, 2019

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 27, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Multiple Sclerosis; Preventive program
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: EK-VP/25/0/2014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No