Parkinson DiseaseNCT01420796
Swallowing and Breathing Exercises for Dysphagia in Parkinson Disease
A study testing Swallowing exercise, Breathing Exercises and Swallowing and breathing exercises in people with Parkinson Disease and Dysphagia, run by Federal University of Bahia at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson Disease, Dysphagia
- What is being tested?
- Swallowing exercise, Breathing Exercises and Swallowing and breathing exercises
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parkinson's disease diagnosed following UKPDS Criteria
- Complaints and symptoms of dysphagia
- Dopaminergic treatment
Who cannot join
- Cranial trauma
- Severe heart disease
- Others neurologic disease
- Psychiatric diseases
- Therapy for swallowing or breathing in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Oral Motor Exercises and Breathing Exercises for Dysphagia in Parkinson Disease: Randomized Clinical Trial
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
- Being tested
- Swallowing exercise, Breathing Exercises, Swallowing and breathing exercises
- Keywords
- Parkinson's disease, dysphagia, swallowing treatment
- Medical subject headings
- Parkinson Disease, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Swallowing exerciseOther
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.
Breathing ExercisesOther
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.
Swallowing and breathing exercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Swallowing and breathing exercises | Experimental | This group will perform both swallowing and breathing exercises for five weeks. Receives: 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. Receives: Other: Swallowing exercise |
| Breathing exercises | Experimental | Expiratory Muscle Training will be performed with Threshold® (Respironics HealthScan, Inc, Cedar Grove, Nova Iorque, EUA). Receives: Other: Breathing Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Swallowing dynamics
Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.
Measured: five weeks
Secondary outcomes (2)
Vocal and speech measures
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.
Measured: five weeks
Breathing measures
Spirometry will be made in KOKO® (software PDS Instrumentation, Inc., Louisville, Colorado, EUA), following American Thoracic Society protocol.
Measured: five weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startNov 2013
- Primary completion15 Dec 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Bahia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalie Argolo Pereira Ponte, Federal University of Bahia
- Investigators
- Ana Caline N. da Costa, Phd, Principal investigator, DINEP/UFBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420796
- Sponsor's protocol ID
- 96/10
- Status last verified
- Apr 2017
- First submitted
- 18 Aug 2011
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oral Motor Exercises and Breathing Exercises for Dysphagia in Parkinson Disease: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01420796
- Acronym / sponsor ID
- 96/10
- Conditions
- Parkinson Disease, Dysphagia
- Keywords
- Parkinson's disease, dysphagia, swallowing treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Federal University of BahiaUniversity, hospital or other
- Study start
- Nov 2013 (actual)
- Primary completion
- 15 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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
| Arm | Type | Receives |
|---|---|---|
| Swallowing and breathing exercises | Experimental | Other: Swallowing and breathing exercisesThis group will perform both swallowing and breathing exercises for five weeks. |
| Swallowing exercises | Experimental | Other: Swallowing exerciseThis 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. |
| Breathing exercises | Experimental | Other: Breathing ExercisesExpiratory Muscle Training will be performed with Threshold® (Respironics HealthScan, Inc, Cedar Grove, Nova Iorque, EUA). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Parkinson's disease diagnosed following UKPDS Criteria
- Complaints and symptoms of dysphagia
- Dopaminergic treatment
Key exclusion criteria (5 listed)
- Cranial trauma
- Severe heart disease
- Others neurologic disease
- Psychiatric diseases
- Therapy for swallowing or breathing in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Swallowing exercisePatients 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. | Other | Swallowing exercises |
| Breathing ExercisesPatients 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. | Other | Breathing exercises |
| Swallowing and breathing exercisesFor 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. | Other | Swallowing and breathing exercises |
Primary outcome
Swallowing dynamics
Time frame: five weeks
Swallowing dynamics will be evaluated through videofluoroscopy of swallowing and electromyography.
2 secondary outcomes
Vocal and speech measures
Time frame: five weeks
Breathing measures
Time frame: five weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ana Caline N. da Costa, Phd principal investigator
DINEP/UFBA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Swallowing exercise, Breathing Exercises and Swallowing and breathing exercises in people with Parkinson Disease and Dysphagia, run by Federal University of Bahia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallowing dynamics (time frame: five weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2017.