Clinical trial NCT01420796: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Dysphagia
Keywords: Parkinson's disease
dysphagia
swallowing treatment
Lead sponsor: Federal University of Bahia
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Swallowing dynamics
timeFrame: five weeks
Secondary outcomes:
measure: Vocal and speech measures
timeFrame: five weeks
measure: Breathing measures
timeFrame: five weeks
Other outcomes:
Locations:
city: Salvador
country: Brazil
facility: Division of Neurology and Epidemiology
state: Bahia
Study officials:
affiliation: DINEP/UFBA
name: Ana Caline N. da Costa, Phd
role: PRINCIPAL_INVESTIGATOR
References: