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Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.

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ClinicalTrials.gov Identifier: NCT04252599
Recruitment Status : Recruiting
First Posted : February 5, 2020
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Marie Carmen Valenza, Universidad de Granada

Study Description
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Brief 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. 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.

Condition or disease
Multiple Sclerosis

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Other
Official Title: Upper Airway Function and Cardiorespiratory Performance in Impair Trunk Motor Control Multiple Sclerosis Patients.
Actual Study Start Date : November 20, 2019
Actual Primary Completion Date : December 2, 2019
Estimated Study Completion Date : January 24, 2020

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Groups and Cohorts
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Group/Cohort
Control group
Multiple sclerosis group
Multiple sclerosis trunk impairment


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. Ventilation function [ Time Frame: baseline ]
    Ventilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy).

  5. Phonation function [ Time Frame: baseline ]
    The phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30),

  6. The exercise capacity focussed on lower limbs [ Time Frame: baseline ]
    The Five-Times-Sit-to-Stand test (5STS)

  7. 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)

  8. The anaerobic threshold [ Time Frame: baseline ]
    Incremental sit-to-stand test (ISTS)


Secondary Outcome Measures :
  1. Psychological status [ Time Frame: baseline ]
    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.

  2. Psychological status [ Time Frame: baseline ]
    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.

  3. The degree of neurological functioning [ Time Frame: baseline ]
    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.

  4. The impact of the multiple sclerosis disease [ Time Frame: baseline ]

    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.



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04252599


Contacts
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Contact: Marie Carmen Valenza, PhD 958248035 cvalenza@ugr.es

Locations
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Spain
Faculty of Healthy Sciences Recruiting
Granada, Spain, 18016
Contact: Marie Carmen Valenza, PhD    958248035    cvalenza@ugr.es   
Sponsors and Collaborators
Universidad de Granada
More Information
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Responsible Party: Marie Carmen Valenza, assistant professor, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04252599    
Other Study ID Numbers: DF0088UG
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases