NCT04667130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable multiple-sclerosis

Timeline
Completed

Started Oct 2017

Typical duration for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
24 days until next milestone

First Posted

Study publicly available on registry

December 14, 2020

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

November 20, 2020

Last Update Submit

January 27, 2021

Conditions

Multiple Sclerosis

Keywords

Preventive programMultiple SclerosisRehabilitation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (10)

  • Ventilation capacity

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

  • Metabolic utilization

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

  • Maximal oxygen uptake

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

  • Maximal oxygen pulse

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

  • Relative ventilation

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

  • +5 more secondary outcomes

Other Outcomes (1)

  • Questionnaires - Modified Fatigue Impact Scale

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

Study Arms (1)

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

EXPERIMENTAL

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

Interventions

Preventive Complex Program for Newly Diagnosed People With Multiple SclerosisBEHAVIORAL

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.

Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • other neurological disease or conditions disabling movement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kamila Řasová

Prague, 128 00, Czechia

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Kamila Řasová, Ph.D.

    Charles University, Czech Republic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
associate professor PhDr. Kamila Řasová, Ph.D.

Study Record Dates

First Submitted

November 20, 2020

First Posted

December 14, 2020

Study Start

October 1, 2017

Primary Completion

October 1, 2019

Study Completion

October 1, 2019

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations

CZ(1)