Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease
This study has been completed.
Sponsor:
Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT01420796
First Posted: August 22, 2011
Last Update Posted: April 27, 2017
Information provided by (Responsible Party):
Natalie Argolo Pereira Ponte, Federal University of Bahia
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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 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 |
Resource links provided by NLM:
Further study details as provided by Natalie Argolo Pereira Ponte, Federal University of Bahia:
Primary Outcome Measures:
- Swallowing dynamics [ Time Frame: five weeks ]Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.
Secondary Outcome Measures:
- 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.
- Breathing measures [ Time Frame: five weeks ]Spirometry will be made in KOKO® (software PDS Instrumentation, Inc., Louisville, Colorado, EUA), following American Thoracic Society protocol.
| Enrollment: | 38 |
| Actual Study Start Date: | November 2013 |
| Study Completion Date: | December 15, 2016 |
| Primary Completion Date: | December 15, 2016 (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.
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Eligibility
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| Ages Eligible for Study: | Child, Adult, Senior |
| 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
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
| 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 Submitted: | August 18, 2011 |
| First Posted: | August 22, 2011 |
| 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 |