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Dysphagia in Parkinson's disease(PD) is common and its presence is related to motor and sensory abnormalities, and incoordination between swallowing and breathing. Despite harming as respiratory infections and increased risk of death, treatment of this condition remains uncertain. This study aims to evaluate the effect of oral motor exercises on the swallowing dynamics and quality of life of dysphagic Parkinson's disease patients. This study is an open trial, self-paired and blinded to the examiner. The participants will perform oropharyngeal exercises for five weeks and will be evaluated before and after intervention by swallowing videofluoroscopy and questionnaires about quality of life in dysphagia (SWAL-QOL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Swallowing exercises | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motor exercises for swallowing, breathing and phonation | Other | This exercises aimed to increase strength and range of motion of mouth, larynx and pharynx structures. All patients made 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. Patients underwent oral motor exercises twice a day, five days a week, for five weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Oropharyngeal Swallowing Score | Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group. | five weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life. | five weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Caline Nóbrega, PhD | Federal University of Bahia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal University of Bahia | Salvador | Estado de Bahia | 40110-170 | Brazil |
Patients with severe dysphagia who needed others interventions (for example: management of food consistency, alternative way of feeding) were excluded. During the study, subjects with absence in three sessions of exercises were excluded from the study and sent to Ambulatory of Speech and Deglutition Disorders at Federal University of Bahia.
Consecutive patients from Movement Disorders Ambulatory of Federal University of Bahia in Brazil with idiopathic Parkinson disease (IPD) and complaint of dysphagia, from March 2009 to June 2010, were invited to participate.
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| ID | Title | Description |
|---|---|---|
| FG000 | Swallowing Exercise Group | One group made swallowing exercises for five weeks. This group was compared before and after the study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Swallowing Exercise Group | One group made swallowing exercises for five weeks. This group was compared before and after the study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Quality of Life | Measured by the Swal-qol (Quality of life in Swallowing disorders). In this questionnaire the score range from 0 to 100 and higher scores is better quality of life. | Posted | Median | Inter-Quartile Range | scores in a scale | five weeks |
|
Adverse event was not collected after end of study.
No formal tool to collect adverse event was used because there is no report that oral exercise can cause adverse event.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Swallowing Exercise Group | One group made swallowing exercises for five weeks. This group was compared before and after the study. |
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There was a delay because of faulty equipment that performs videofluoroscopy of swallowing.
Study limitations include small number of participants and no comparison group.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Natalie Argolo Ponte | University Federal of Bahia | 55 31 3274 5579 | natyargolo@hotmail.com |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003680 | Deglutition Disorders |
| D014832 | Voice Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D003679 | Deglutition |
| D012119 | Respiration |
| D010699 | Phonation |
| ID | Term |
|---|---|
| D004068 | Digestive System Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012143 | Respiratory Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
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|
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Oropharyngeal Swallowing Score | Based on videofluoroscopy, were awarded points for the swallowing events according to their clinical relevance. The sum of these points results in the OSP (Oropharyngeal Swallowing Score), so that higher scores signify greater impairment in swallowing. OSP-score range from 0 to 243.5. This tool is being validated for that group. | Posted | Mean | Standard Deviation | Scores on a scale | five weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |