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

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.

Study Overview

• Status: Unknown
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18016
    • Recruiting
    • Faculty of Healthy Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Control group
Multiple sclerosis group
Multiple sclerosis trunk impairment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): December 2, 2019
• Study Completion (Anticipated): January 24, 2020

Study Registration Dates

• First Submitted: January 23, 2020
• First Submitted That Met QC Criteria: January 30, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): February 5, 2020
• Last Update Submitted That Met QC Criteria: January 30, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: DF0088UG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No