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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04252599
• Other study ID #: DF0088UG
• Status: Recruiting
• Start date: November 20, 2019
• Est. completion date: January 24, 2020

Study information

• Verified date: January 2020
• Source: Universidad de Granada
• Contact: Marie Carmen Valenza, PhD
• Phone: 958248035
• Email: cvalenza[@]ugr.es
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 24, 2020
• Est. primary completion date: December 2, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Spain	Faculty of Healthy Sciences	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

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