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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04252599
Enrollment
60
Registered
2020-02-05
Start date
2019-11-20
Completion date
2020-01-24
Last updated
2020-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

None listed

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The anaerobic thresholdbaselineIncremental sit-to-stand test (ISTS)
Phonation functionbaselineThe phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30),
The exercise capacity focussed on lower limbsbaselineThe Five-Times-Sit-to-Stand test (5STS)
The exercise capacity focussed on upper limbsbaselineThe exercise capacity focussed on upper limbs was measured by the unsupported upper-limb exercise test (UULEX)
Trunk motor controlbaselineThe 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 functionbaselineTo 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).
Ventilation functionbaselineVentilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy).

Secondary

MeasureTime frameDescription
The degree of neurological functioningbaselineThe 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.
The impact of the multiple sclerosis diseasebaselineThe 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.
Psychological statusbaselinePsychological 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.

Countries

Spain

Contacts

Primary ContactMarie Carmen Valenza, PhD
cvalenza@ugr.es958248035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026