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Preventive Program in Multiple Sclerosis

2021年1月27日 更新者：Kamila Řasová

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.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

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).

研究の種類

介入

入学 (実際)

17

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • チェコ
      • Praha、チェコ、128 00
        • Kamila Řasová

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～70年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
行動：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Questionnaires - The Fatigue scale for motor and cognitive functions
時間枠：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).
change after six months of the program and after next six moths without therapy is being assessed
Questionnaires - The Satisfaction With Life Scale
時間枠：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).
change after six months of the program and after next six moths without therapy is being assessed
Questionnaires - Multiple Sclerosis Acceptance Questionnaire
時間枠：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) .
change after six months of the program and after next six moths without therapy is being assessed
Questionnaires - Beck Depression Inventory Score
時間枠：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.
change after six months of the program and after next six moths without therapy is being assessed

二次結果の測定

結果測定
メジャーの説明
時間枠
Ventilation capacity
時間枠：change after six months of the program and after next six moths without therapy is being assessed
Forced vital capacity = FVC [ l ]
change after six months of the program and after next six moths without therapy is being assessed
Metabolic utilization
時間枠：change after six months of the program and after next six moths without therapy is being assessed
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
時間枠：change after six months of the program and after next six moths without therapy is being assessed
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
時間枠：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 ]
change after six months of the program and after next six moths without therapy is being assessed
Relative ventilation
時間枠：change after six months of the program and after next six moths without therapy is being assessed
[ VEmax.kg-1 ]
change after six months of the program and after next six moths without therapy is being assessed
Cortisol
時間枠：change after six months of the program and after next six moths without therapy is being assessed
levels of cortisol [ ng/mL ]
change after six months of the program and after next six moths without therapy is being assessed
Cortizone
時間枠：change after six months of the program and after next six moths without therapy is being assessed
levels of cortisone[ ng/mL ]
change after six months of the program and after next six moths without therapy is being assessed
Dehydroepiandrosterone (DHEA)
時間枠：change after six months of the program and after next six moths without therapy is being assessed
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 )
時間枠：change after six months of the program and after next six moths without therapy is being assessed
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 )
時間枠：change after six months of the program and after next six moths without therapy is being assessed
levels of 7-oxo-DHEA [ ng/mL ]
change after six months of the program and after next six moths without therapy is being assessed

その他の成果指標

結果測定
メジャーの説明
時間枠
Questionnaires - Modified Fatigue Impact Scale
時間枠：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.
change after six months of the program and after next six moths without therapy is being assessed

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Kamila Řasová

捜査官

  • 主任研究者：Kamila Řasová, Ph.D.、Third Faculty of Medicine Charles University

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2017年10月1日

一次修了 (実際)

2019年10月1日

研究の完了 (実際)

2019年10月1日

試験登録日

最初に提出

2020年11月20日

QC基準を満たした最初の提出物

2020年12月9日

最初の投稿 (実際)

2020年12月14日

学習記録の更新

投稿された最後の更新 (実際)

2021年2月1日

QC基準を満たした最後の更新が送信されました

2021年1月27日

最終確認日

2021年1月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • EK-VP/25/0/2014

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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