Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease - Full Text View

Purpose

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	Intervention
Parkinson Disease Dysphagia	Other: Swallowing exercise Other: Breathing Exercises Other: Swallowing and breathing exercises


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of Oral Motor Exercises and Breathing Exercises for Dysphagia in Parkinson Disease: Randomized Clinical Trial

Resource links provided by NLM:

Genetics Home Reference related topics: Parkinson disease Perry syndrome

MedlinePlus related topics: Exercise and Physical Fitness Parkinson's Disease Swallowing Disorders

U.S. FDA Resources

Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:

Swallowing dynamics [ Time Frame: five weeks ] [ Designated as safety issue: No ]
Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.

Secondary Outcome Measures:

Vocal and speech measures [ Time Frame: five weeks ] [ Designated as safety issue: No ]
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.
Breathing measures [ Time Frame: five weeks ] [ Designated as safety issue: No ]
Spirometry will be made in KOKO® (software PDS Instrumentation, Inc., Louisville, Colorado, EUA), following American Thoracic Society protocol.


Estimated Enrollment:	100
Study Start Date:	November 2013
Estimated Study Completion Date:	July 2016
Estimated Primary Completion Date:	April 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	Child, Adult, Senior
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420796

Contacts


Contact: Ana Caline N. da Costa, PhD	5571 99759905	anacaline@uol.com.br

Locations


Brazil
Division of Neurology and Epidemiology	Recruiting
Salvador, Bahia, Brazil
Contact: Patricia F Pinho, MsC 55 71 3247 6982 patricia_francesca@yahoo.com.br
Principal Investigator: Ana Caline N. Costa, PhD

Sponsors and Collaborators

Federal University of Bahia

Investigators


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

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
Study First Received:	August 18, 2011
Last Updated:	August 26, 2015
Health Authority:	Brazil: Ministry of Health

Keywords provided by Federal University of Bahia:


Parkinson's disease dysphagia swallowing treatment

Additional relevant MeSH terms:


Deglutition Disorders Parkinson Disease 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

ClinicalTrials.gov processed this record on September 29, 2016