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Preventive Program in Multiple Sclerosis

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Sponsored by
Kamila Řasová
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Sclerosis focused on measuring Preventive program, Multiple Sclerosis, Rehabilitation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kamila Řasová

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

Arm Description

Providing information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise

Outcomes

Primary Outcome Measures

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).
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).
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) .
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.

Secondary Outcome Measures

Ventilation capacity
Forced vital capacity = FVC [ l ]
Metabolic utilization
maximal muscle performance = Rmax [ Watt kg-1 ]
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 ]
Cortisol
levels of cortisol [ ng/mL ]
Cortizone
levels of cortisone[ ng/mL ]
Dehydroepiandrosterone (DHEA)
levels of DHEA [ ng/mL ]
7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
levels of 7β-OH-DHEA [ ng/mL ]
7-oxo dehydroepiandrosterone (7-oxo-DHEA )
levels of 7-oxo-DHEA [ ng/mL ]

Full Information

First Posted
November 20, 2020
Last Updated
January 27, 2021
Sponsor
Kamila Řasová
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1. Study Identification

Unique Protocol Identification Number
NCT04667130
Brief Title
Preventive Program in Multiple Sclerosis
Official Title
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
October 1, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Kamila Řasová

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Preventive program, Multiple Sclerosis, Rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Arm Type
Experimental
Arm Description
Providing information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise
Intervention Type
Behavioral
Intervention Name(s)
Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Questionnaires - The Fatigue scale for motor and cognitive functions
Description
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
Title
Questionnaires - The Satisfaction With Life Scale
Description
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
Title
Questionnaires - Multiple Sclerosis Acceptance Questionnaire
Description
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
Title
Questionnaires - Beck Depression Inventory Score
Description
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
Secondary Outcome Measure Information:
Title
Ventilation capacity
Description
Forced vital capacity = FVC [ l ]
Time Frame
change after six months of the program and after next six moths without therapy is being assessed
Title
Metabolic utilization
Description
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
Title
Maximal oxygen uptake
Description
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
Title
Maximal oxygen pulse
Description
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
Title
Relative ventilation
Description
[ VEmax.kg-1 ]
Time Frame
change after six months of the program and after next six moths without therapy is being assessed
Title
Cortisol
Description
levels of cortisol [ ng/mL ]
Time Frame
change after six months of the program and after next six moths without therapy is being assessed
Title
Cortizone
Description
levels of cortisone[ ng/mL ]
Time Frame
change after six months of the program and after next six moths without therapy is being assessed
Title
Dehydroepiandrosterone (DHEA)
Description
levels of DHEA [ ng/mL ]
Time Frame
change after six months of the program and after next six moths without therapy is being assessed
Title
7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
Description
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
Title
7-oxo dehydroepiandrosterone (7-oxo-DHEA )
Description
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
Other Pre-specified Outcome Measures:
Title
Questionnaires - Modified Fatigue Impact Scale
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kamila Řasová, Ph.D.
Organizational Affiliation
Third Faculty of Medicine Charles University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamila Řasová
City
Praha
ZIP/Postal Code
128 00
Country
Czechia

12. IPD Sharing Statement

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Preventive Program in Multiple Sclerosis

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