ClinicalTrials.gov
ClinicalTrials.gov Menu

Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01420796
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
Natalie Argolo Pereira Ponte, Federal University of Bahia

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01420796


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
Go to 
Top of Page 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    Key Record Dates
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