Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease

NCT01420796 | Completed DMC

• 1 other identifier: 96/10
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Dysphagia

Keywords

Parkinson's disease; dysphagia; swallowing treatment

Outcome Measures

Primary Outcomes (1)

• Swallowing dynamics

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

  five weeks

Secondary Outcomes (2)

• Vocal and speech measures

  five weeks

• Breathing measures

  five weeks

Study Arms (3)

Swallowing and breathing exercises

EXPERIMENTAL

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

Other: Swallowing and breathing exercises

Swallowing exercises

EXPERIMENTAL

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

Breathing exercises

EXPERIMENTAL

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

Other: Breathing Exercises

Interventions

Swallowing exercise OTHER

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.

Swallowing exercises

Breathing Exercises OTHER

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.

Breathing exercises

Swallowing and breathing exercises OTHER

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.

Swallowing and breathing exercises

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Parkinson's disease diagnosed following UKPDS Criteria
• Complaints and symptoms of dysphagia
• Dopaminergic treatment

You may not qualify if:

• Cranial trauma
• Severe heart disease
• Others neurologic disease
• Psychiatric diseases
• Therapy for swallowing or breathing in the last 3 months

Sponsors & Collaborators

• Federal University of Bahia: lead

Study Sites (1)

Division of Neurology and Epidemiology

Salvador, Estado de Bahia, Brazil

Location

MeSH Terms

Conditions

Parkinson Disease; Deglutition Disorders

Interventions

Breathing Exercises; Deglutition

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities; Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Ana Caline N. da Costa, Phd

  DINEP/UFBA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: 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

Study Record Dates

• First Submitted: August 18, 2011
• First Posted: August 22, 2011
• Study Start: November 1, 2013
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: April 27, 2017

Record last verified: 2017-04

Locations

BR (1)