CClinicalTrials.gg
Status unknownNCT04252599Updated Feb 5, 2020

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

An observational study in Multiple Sclerosis, sponsored by Universidad de Granada. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-05.

Sponsored by Universidad de Granada · Observational

The sponsor has not verified this record recently (last verified Jan 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
60
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Multiple Sclerosis
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 60 is below the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Universidad de Granada is the lead sponsor of 241 studies on the registry; 41 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

Exclusion Criteria:

  • Cancer diagnoses, cognitive or psychiatric disorders, severe musculoskeletal disorders, severe orthopaedic problems, organ failure, incapacity to cooperate
  • Inability to provide informed consent.
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Study design

Observational model
Other
Time perspective
Other
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • Control group
  • Multiple sclerosis group
  • Multiple sclerosis trunk impairment
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline

  2. 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).

    Time frame: baseline

  3. 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.

    Time frame: baseline

  4. Ventilation function

    Ventilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy).

    Time frame: baseline

  5. Phonation function

    The phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30),

    Time frame: baseline

  6. The exercise capacity focussed on lower limbs

    The Five-Times-Sit-to-Stand test (5STS)

    Time frame: baseline

  7. The exercise capacity focussed on upper limbs

    The exercise capacity focussed on upper limbs was measured by the unsupported upper-limb exercise test (UULEX)

    Time frame: baseline

  8. The anaerobic threshold

    Incremental sit-to-stand test (ISTS)

    Time frame: baseline

Secondary outcomes

  1. 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.

    Time frame: baseline

  2. 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.

    Time frame: baseline

  3. 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.

    Time frame: baseline

  4. 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.

    Time frame: baseline

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Study locations

1 of 1 sites recruiting
  • Faculty of Healthy Sciences
    Granada, 18016, Spain
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04252599
Lead sponsor
Universidad de Granada
Responsible party
Marie Carmen Valenza (assistant professor, Universidad de Granada) — Principal investigator
First posted
Feb 5, 2020
Start date
Nov 20, 2019
Primary completion
Dec 2, 2019
Completion
Jan 24, 2020 (estimated)
Last update
Feb 5, 2020

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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