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Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease

Primary Purpose

Parkinson Disease, Dysphagia

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Swallowing exercise
Breathing Exercises
Swallowing and breathing exercises
Sponsored by
Federal University of Bahia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, dysphagia, swallowing treatment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Division of Neurology and Epidemiology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Swallowing and breathing exercises

Swallowing exercises

Breathing exercises

Arm Description

This group will perform both swallowing and breathing exercises for five weeks.

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.

Expiratory Muscle Training will be performed with Threshold® (Respironics HealthScan, Inc, Cedar Grove, Nova Iorque, EUA).

Outcomes

Primary Outcome Measures

Swallowing dynamics
Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.

Secondary Outcome Measures

Vocal and speech measures
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
Spirometry will be made in KOKO® (software PDS Instrumentation, Inc., Louisville, Colorado, EUA), following American Thoracic Society protocol.

Full Information

First Posted
August 18, 2011
Last Updated
April 25, 2017
Sponsor
Federal University of Bahia
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1. Study Identification

Unique Protocol Identification Number
NCT01420796
Brief Title
Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease
Official Title
Effect of Oral Motor Exercises and Breathing Exercises for Dysphagia in Parkinson Disease: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2013 (Actual)
Primary Completion Date
December 15, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Bahia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Dysphagia
Keywords
Parkinson's disease, dysphagia, swallowing treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Swallowing and breathing exercises
Arm Type
Experimental
Arm Description
This group will perform both swallowing and breathing exercises for five weeks.
Arm Title
Swallowing exercises
Arm Type
Experimental
Arm Description
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.
Arm Title
Breathing exercises
Arm Type
Experimental
Arm Description
Expiratory Muscle Training will be performed with Threshold® (Respironics HealthScan, Inc, Cedar Grove, Nova Iorque, EUA).
Intervention Type
Other
Intervention Name(s)
Swallowing exercise
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breathing Exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Swallowing and breathing exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Swallowing dynamics
Description
Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.
Time Frame
five weeks
Secondary Outcome Measure Information:
Title
Vocal and speech measures
Description
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.
Time Frame
five weeks
Title
Breathing measures
Description
Spirometry will be made in KOKO® (software PDS Instrumentation, Inc., Louisville, Colorado, EUA), following American Thoracic Society protocol.
Time Frame
five weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Caline N. da Costa, Phd
Organizational Affiliation
DINEP/UFBA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Neurology and Epidemiology
City
Salvador
State/Province
Bahia
Country
Brazil

12. IPD Sharing Statement

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Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease

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