Multiple SclerosisNCT04667130
Preventive Program in Multiple Sclerosis
A study testing Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis in people with Multiple Sclerosis, run by Kamila Řasová at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Oct 2017to 1 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- other neurological disease or conditions disabling movement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Multiple Sclerosis
- Being tested
- Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
- Keywords
- Preventive program, Multiple Sclerosis, Rehabilitation
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive Complex Program for Newly Diagnosed People With Multiple SclerosisBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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) .
Measured: 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.
Measured: change after six months of the program and after next six moths without therapy is being assessed
Secondary outcomes (10)
Ventilation capacity
Forced vital capacity = FVC [ l ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Metabolic utilization
maximal muscle performance = Rmax [ Watt kg-1 ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Maximal oxygen uptake
VO2 kg-1 [ VO2max.kg-1 ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Maximal oxygen pulse
VO2 HR-1 kg-1 [ VO2max.TF-1 ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Relative ventilation
[ VEmax.kg-1 ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Cortisol
levels of cortisol [ ng/mL ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Cortizone
levels of cortisone[ ng/mL ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Dehydroepiandrosterone (DHEA)
levels of DHEA [ ng/mL ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
levels of 7β-OH-DHEA [ ng/mL ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
7-oxo dehydroepiandrosterone (7-oxo-DHEA )
levels of 7-oxo-DHEA [ ng/mL ]
Measured: change after six months of the program and after next six moths without therapy is being assessed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start1 Oct 2017
- Primary completion1 Oct 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kamila Řasová
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kamila Řasová, Charles University, Czech Republic
- Investigators
- Kamila Řasová, Ph.D., Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04667130
- Sponsor's protocol ID
- EK-VP/25/0/2014
- Status last verified
- Jan 2021
- First submitted
- 20 Nov 2020
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04667130
- Acronym / sponsor ID
- EK-VP/25/0/2014
- Conditions
- Multiple Sclerosis
- Keywords
- Preventive program, Multiple Sclerosis, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kamila ŘasováUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Oct 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis | Experimental | Behavioral: Preventive Complex Program for Newly Diagnosed People With Multiple SclerosisProviding information about the possibilities of physiotherapy, Computer Kinesiology, psychotherapy, Motor progam activating therapy, aerobic exercise |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- other neurological disease or conditions disabling movement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive Complex Program for Newly Diagnosed People With Multiple SclerosisPreventive 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. | Behavioural | Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis |
Primary outcome
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).
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).
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) .
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.
10 secondary outcomes
Ventilation capacity
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Metabolic utilization
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Maximal oxygen uptake
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Maximal oxygen pulse
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Relative ventilation
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Cortisol
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Cortizone
Time frame: change after six months of the program and after next six moths without therapy is being assessed
Dehydroepiandrosterone (DHEA)
Time frame: change after six months of the program and after next six moths without therapy is being assessed
7β-hydroxydehydroepiandrosterone (7β-OH-DHEA )
Time frame: change after six months of the program and after next six moths without therapy is being assessed
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Řasová, Ph.D. principal investigator
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis in people with Multiple Sclerosis, run by Kamila Řasová at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021.