Multiple SclerosisNCT04252599
Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.
An observational study of Multiple Sclerosis, run by Universidad de Granada at 1 site in Spain.
Trial summary
Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 20 Nov 2019to 24 Jan 2020
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Inclusion Criteria: * Have a diagnosis of MS in any of its forms according to McDonald criteria * Were aged higher than 18 years * No pathology in the uppers extremities * Capacity to understand and response the questionnaires * Ability to provide informed consent. Exclusion Criteria: * Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate * Inability to provide informed consent.
Who may be able to join
- Have a diagnosis of MS in any of its forms according to McDonald criteria
- Were aged higher than 18 years
- No pathology in the uppers extremities
- Capacity to understand and response the questionnaires
- Ability to provide informed consent.
Who cannot join
- Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Faculty of Healthy Sciences
Granada, 18016
Marie Carmen Valenza, PhD, 958248035, cvalenza@ugr.es
About this study
Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. Different areas are affected, including upper airway function, trunk motor control and cardiorespiratory performance. The aim of this study was to determinate the relevance of trunk motor control in upper airway function and cardiorespiratory performance in patients with multiple sclerosis.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Not described | |
| Multiple sclerosis group | Not described | |
| Multiple sclerosis trunk impairment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunk motor control
The impairment of trunk motor control was measured with the Modified Trunk Impairment Scale (mTIS). The values range to 0 from 16 being higher values, better trunk motor control.
Measured: baseline
Swallowing function
To evaluate swallowing function we used two questionnaires: the Swallowing quality of life questionnaire (SWAL-QOL). It contains 44 items and each item was scored from zero (the worst state) to four (the best state).
Measured: baseline
Swallowing function
To evaluate swallowing function we used two questionnaires: the Eating Assessment Tool-10 (EAT-10). The values range from 0 to 4 being higher values worse swallowing function.
Measured: baseline
Ventilation function
Ventilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy).
Measured: baseline
Phonation function
The phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30),
Measured: baseline
The exercise capacity focussed on lower limbs
The Five-Times-Sit-to-Stand test (5STS)
Measured: baseline
The exercise capacity focussed on upper limbs
The exercise capacity focussed on upper limbs was measured by the unsupported upper-limb exercise test (UULEX)
Measured: baseline
The anaerobic threshold
Incremental sit-to-stand test (ISTS)
Measured: baseline
Secondary outcomes (4)
Psychological status
Psychological status was evaluated with and the Beck Depression Inventory (Beck) to measure depression. The values range to 0 from 63, being higher values, most severe depression.
Measured: baseline
Psychological status
Psychological status was evaluated with the Beck Anxiety Inventory (BAI) to measure anxiety. The values range to 0 from 63, being higher values, most severe anxiety.
Measured: baseline
The degree of neurological functioning
The degree of neurological functioning in patients with MS was measured with the Kurtzke Expanded Disability Status Scale (EDSS). The values range to 0 from 10, being 0 normal status healthy and 10 the death.
Measured: baseline
The impact of the multiple sclerosis disease
The impact of the disease was determinate with the Multiple Sclerosis Impact Scale (MSIS-29).
It´s an instrument with 20 physical items and 9 psychological items.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start20 Nov 2019
- Primary completion2 Dec 2019
- Study completion24 Jan 2020 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04252599
- Sponsor's protocol ID
- DF0088UG
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2020
- Last updated
- 5 Feb 2020
- 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 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.
- ClinicalTrials.gov ID
- NCT04252599
- Acronym / sponsor ID
- DF0088UG
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 20 Nov 2019 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 24 Jan 2020 (estimated)
- First posted
- 5 Feb 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.
Multiple sclerosis is a chronic and highly disabling disorder with considerable social impact and economic consequences. It is caused by damage to the myelin sheath, the protective covering that surrounds nerve cells. Different areas are affected, including upper airway function, trunk motor control and cardiorespiratory performance. The aim of this study was to determinate the relevance of trunk motor control in upper airway function and cardiorespiratory performance in patients with multiple sclerosis.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | – | – |
| Multiple sclerosis group | – | – |
| Multiple sclerosis trunk impairment | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion Criteria: * Have a diagnosis of MS in any of its forms according to McDonald criteria * Were aged higher than 18 years * No pathology in the uppers extremities * Capacity to understand and response the questionnaires * Ability to provide informed consent. Exclusion Criteria: * Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate * Inability to provide informed consent.
Key inclusion criteria (5 listed)
- Have a diagnosis of MS in any of its forms according to McDonald criteria
- Were aged higher than 18 years
- No pathology in the uppers extremities
- Capacity to understand and response the questionnaires
- Ability to provide informed consent.
Key exclusion criteria (2 listed)
- Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate
- Inability to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trunk motor control
Time frame: baseline
The impairment of trunk motor control was measured with the Modified Trunk Impairment Scale (mTIS). The values range to 0 from 16 being higher values, better trunk motor control.
Swallowing function
Time frame: baseline
To evaluate swallowing function we used two questionnaires: the Swallowing quality of life questionnaire (SWAL-QOL). It contains 44 items and each item was scored from zero (the worst state) to four (the best state).
Swallowing function
Time frame: baseline
To evaluate swallowing function we used two questionnaires: the Eating Assessment Tool-10 (EAT-10). The values range from 0 to 4 being higher values worse swallowing function.
Ventilation function
Time frame: baseline
Ventilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy).
Phonation function
Time frame: baseline
The phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30),
The exercise capacity focussed on lower limbs
Time frame: baseline
The Five-Times-Sit-to-Stand test (5STS)
The exercise capacity focussed on upper limbs
Time frame: baseline
The exercise capacity focussed on upper limbs was measured by the unsupported upper-limb exercise test (UULEX)
The anaerobic threshold
Time frame: baseline
Incremental sit-to-stand test (ISTS)
4 secondary outcomes
Psychological status
Time frame: baseline
Psychological status
Time frame: baseline
The degree of neurological functioning
Time frame: baseline
The impact of the multiple sclerosis disease
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Universidad de Granada at 1 site in Spain.
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 5 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 5 Feb 2020. 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 Spain. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Carmen Valenza, PhD (958248035, cvalenza@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trunk motor control (time frame: baseline). The study lists 8 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 5 Feb 2020.