- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01420796
Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease
Effect of Oral Motor Exercises and Breathing Exercises for Dysphagia in Parkinson Disease: Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil
- Division of Neurology and Epidemiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Swallowing and breathing exercises
This group will perform both swallowing and breathing exercises for five weeks.
|
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.
|
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).
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Swallowing dynamics
Time Frame: five weeks
|
Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.
|
five weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
five weeks
|
Breathing measures
Time Frame: five weeks
|
Spirometry will be made in KOKO® (software PDS Instrumentation, Inc., Louisville, Colorado, EUA), following American Thoracic Society protocol.
|
five weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ana Caline N. da Costa, Phd, DINEP/UFBA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Gastrointestinal Diseases
- Pharyngeal Diseases
- Otorhinolaryngologic Diseases
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Esophageal Diseases
- Parkinson Disease
- Deglutition Disorders
Other Study ID Numbers
- 96/10
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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