Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease
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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 |
- Swallowing dynamics [ Time Frame: five weeks ] [ Designated as safety issue: No ]Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and eletromiography.
- 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 eletroglotographical measures will be assessed on EG2 - PCX equipament.
- 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 2013 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (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 |
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| Contact: Ana Caline N. da Costa, PhD | 5571 99759905 | anacaline@uol.com.br |
| Brazil | |
| Division of Neurology and Epidemiology | Not yet recruiting |
| Salvador, Bahia, Brazil | |
| Principal Investigator: Ana Caline N. Costa, PhD | |
| 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: | November 4, 2012 |
| 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 May 16, 2013