Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease

Study Description

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Brief Summary:

Parkinson's disease (PD) is a chronic, degenerative disease described by motors and non-motors symptoms. Changes in swallowing and respiratory dynamics increase risk of tracheal aspiration largely responsible for increased morbidity and mortality in this population. Thus, interdisciplinary rehabilitation strategies can reduce the complications of dysphagia, with consequent improvement of the prognosis of individuals with PD. Objective: To determine the impact of combined oral motor exercises and breathing exercises on swallowing disorders in individuals with PD. Method: Clinical trial, randomized and blinded for the examinator. For all subjects will be given the stage of PD and applied quality of life questionnaire. The swallowing complaints will be investigated through structured questionnaire and functional aspects of swallowing with videofluoroscopy. The Manovacuometry Spirometry will determine measures of respiratory function. The assessment of vocal and speech disorders will be done with perceptive, acoustic, aerodynamic and electroglottographic measures as well as analysis of intelligibility. Three groups of intervention will be defined: one of them doing oral motor exercises for swallowing, one doing breathing exercises and another must do this two interventions combined. Effect of intervention will be assessed through measures of swallowing, breathing, voice and speech. The groups will be compared, according to the principle of "intention to treat" by appropriate statistical tests, according to the distribution of the dependent variables.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease; Dysphagia	Other: Swallowing exercise; Other: Breathing Exercises; Other: Swallowing and breathing exercises	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	38 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	3 arms were designed to evaluate the effect of swallowing and breathing exercises to dysphagia in PD patients. The groups were allocated randomly in A) swallowing exercises; b) Breathing exercises or C) Swallowing and breathing exercises
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effect of Oral Motor Exercises and Breathing Exercises for Dysphagia in Parkinson Disease: Randomized Clinical Trial
Actual Study Start Date :	November 2013
Actual Primary Completion Date :	December 15, 2016
Actual Study Completion Date :	December 15, 2016

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Swallowing and breathing exercises; This group will perform both swallowing and breathing exercises for five weeks.	Other: Swallowing and breathing exercises; For five weeks, patients will perform swallowing and breathing exercises that follow: expiratory muscle training and sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side.
Experimental: Swallowing exercises; This exercises aim to increase strength and range of motion of mouth, larynx and pharynx structures. All patients will perform sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side.	Other: Swallowing exercise; Patients will perform oral motor exercises for swallowing muscles for five weeks, four days a week. This exercises aim to increase strength and range of motion of mouth, larynx and pharynx structures. All patients will make sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side.
Experimental: Breathing exercises; Expiratory Muscle Training will be performed with Threshold® (Respironics HealthScan, Inc, Cedar Grove, Nova Iorque, EUA).	Other: Breathing Exercises; Patients will perform expiratory muscle training. Initial load will be 30% of maximal expiratory pressure which will increase until 75%. This load will be keep until end of training. Patients will made the exercises for 30 minutes with three minutes of training and two of rest.

Outcome Measures

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Primary Outcome Measures :

1. Swallowing dynamics [ Time Frame: five weeks ]
   Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.

Secondary Outcome Measures :

1. Vocal and speech measures [ Time Frame: five weeks ]
   After recording a sample of speech, aerodynamics measures will be extracted by Aeroview Plus software and measures of test results electroglottography will be assessed on EG2 - PCX equipment.
2. Breathing measures [ Time Frame: five weeks ]
   Spirometry will be made in KOKO® (software PDS Instrumentation, Inc., Louisville, Colorado, EUA), following American Thoracic Society protocol.

Eligibility Criteria

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Ages Eligible for Study:	Child, Adult, Senior
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Parkinson's disease diagnosed following UKPDS Criteria
• Complaints and symptoms of dysphagia
• Dopaminergic treatment

Exclusion Criteria:

• Cranial trauma
• Severe heart disease
• Others neurologic disease
• Psychiatric diseases
• Therapy for swallowing or breathing in the last 3 months

Contacts and Locations

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Locations

Brazil
Division of Neurology and Epidemiology
Salvador, Bahia, Brazil

Sponsors and Collaborators

Federal University of Bahia

Investigators

Principal Investigator:	Ana Caline N. da Costa, Phd	DINEP/UFBA

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Natalie Argolo Pereira Ponte, PhD, Federal University of Bahia
ClinicalTrials.gov Identifier:	NCT01420796 History of Changes
Other Study ID Numbers:	96/10
First Posted:	August 22, 2011
Last Update Posted:	April 27, 2017
Last Verified:	April 2017

Keywords provided by Natalie Argolo Pereira Ponte, Federal University of Bahia:

Parkinson's disease; dysphagia; swallowing treatment

Additional relevant MeSH terms:

Parkinson Disease; Deglutition Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Neurodegenerative Diseases	Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Menthol; Antipruritics; Dermatologic Agents