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

• Conditions: Multiple Sclerosis

• Registration Number: NCT04252599
• Lead Sponsor: Universidad de Granada

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-20
• Primary Completion: 2019-12-02
• Status Verified: 2020-01
• Study First Submitted: 2020-01-23
• Study Completion: 2020-01-24
• Study First Submitted QC: 2020-01-30
• Last Update Submitted: 2020-01-30
• Study First Posted: 2020-02-05
• Last Update Posted: 2020-02-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phonation function	baseline	The phonatory function and it´s repercussion on daily life was evaluated by the Voice handicap index (VHI-30),
Swallowing function	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	baseline	Ventilation capacity was measured with spirometry and peak flow using Spirobank II (MIR, Italy).
The exercise capacity focussed on lower limbs	baseline	The Five-Times-Sit-to-Stand test (5STS)
The exercise capacity focussed on upper limbs	baseline	The exercise capacity focussed on upper limbs was measured by the unsupported upper-limb exercise test (UULEX)
The anaerobic threshold	baseline	Incremental sit-to-stand test (ISTS)
Trunk motor control	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.

Secondary Outcome Measures

Name	Time	Method
The impact of the multiple sclerosis disease	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.
Psychological status	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.
The degree of neurological functioning	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.

Trial Locations

Locations (1)

Faculty of Healthy Sciences; 🇪🇸 Granada, Spain