Preventive Program in Multiple Sclerosis

NCT ID: NCT04667130

Last Updated: 2021-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2019-10-01

Brief Summary

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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

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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).

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kamila Řasová

OTHER

Sponsor Role lead

Responsible Party

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Kamila Řasová

associate professor PhDr. Kamila Řasová, Ph.D.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kamila Řasová, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Third Faculty of Medicine Charles University

Locations

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Kamila Řasová

Prague, , Czechia

Site Status

Countries

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Czechia

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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EK-VP/25/0/2014

Identifier Type: -

Identifier Source: org_study_id

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