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Completed

NCT Number: NCT04667130

Preventive Program in 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kamila Řasová

Prague, 128 00, Czechia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

Behavioral

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 outcomes

  1. Questionnaires - The Fatigue scale for motor and cognitive functions

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    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).

  2. Questionnaires - The Satisfaction With Life Scale

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    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).

  3. Questionnaires - Multiple Sclerosis Acceptance Questionnaire

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    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) .

  4. Questionnaires - Beck Depression Inventory Score

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    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 outcomes

  1. Ventilation capacity

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    Forced vital capacity = FVC [ l ]

  2. Metabolic utilization

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    maximal muscle performance = Rmax [ Watt kg-1 ]

  3. Maximal oxygen uptake

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    VO2 kg-1 [ VO2max.kg-1 ]

  4. Maximal oxygen pulse

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    VO2 HR-1 kg-1 [ VO2max.TF-1 ]

  5. Relative ventilation

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    [ VEmax.kg-1 ]

  6. Cortisol

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    levels of cortisol [ ng/mL ]

  7. Cortizone

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    levels of cortisone[ ng/mL ]

  8. Dehydroepiandrosterone (DHEA)

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    levels of DHEA [ ng/mL ]

  9. 7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    levels of 7β-OH-DHEA [ ng/mL ]

  10. 7-oxo dehydroepiandrosterone (7-oxo-DHEA )

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    levels of 7-oxo-DHEA [ ng/mL ]

Other outcomes

  1. Questionnaires - Modified Fatigue Impact Scale

    Time frame: change after six months of the program and after next six moths without therapy is being assessed

    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.

Sponsors and collaborators

Lead sponsor

Kamila Řasová

Other

Registry information

Official study title

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 14, 2020
Registry last updated
Feb 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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