Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease

This study is not yet open for participant recruitment.
Verified October 2013 by Federal University of Bahia
Sponsor:
Information provided by (Responsible Party):
Natalie Argolo Pereira Ponte, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01420796
First received: August 18, 2011
Last updated: October 20, 2013
Last verified: October 2013
  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:


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: April 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: September 2014 (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

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
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 Not yet recruiting
Salvador, Bahia, Brazil
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

Additional Information:
No publications provided

Responsible Party: Natalie Argolo Pereira Ponte, PhD Student, 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: October 20, 2013
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
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on April 22, 2014