An interventional study of Motor exercises for swallowing, breathing and phonation in Parkinson's Disease, Deglutition Disorders and Voice Disorders, sponsored by Federal University of Bahia. Completed at 1 site in Brazil. Per ClinicalTrials.gov, last updated 2011-11-08.
Sponsored by Federal University of Bahia · Not applicable, Interventional, and Treatment
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).
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
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Exclusion Criteria:
Other: Motor exercises for swallowing, breathing and phonation
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.
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.
Time frame: five weeks
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.
Time frame: five weeks
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.
| Milestone | Swallowing Exercise Group |
|---|---|
| Started | 17 |
| Completed | 15 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
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.
| scores in a scale | Pre-intervention Measure | Post-intervention Measure |
|---|---|---|
| Quality of Life | 64.33 (40.05 to 79.8) | 70.58 (47.72 to 77.13) |
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.
| Scores on a scale | Pre-intervention Measure | Post-intervention Measure |
|---|---|---|
| Oropharyngeal Swallowing Score | 22.15 ± 9.36 | 21.93 ± 12.81 |
Collected over Adverse event was not collected after end of study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Swallowing Exercise Group | — | — | — |
| Age, Categorical(Participants) | Swallowing Exercise Group |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 12 |
| >=65 years | 5 |
| Age Continuous(years) | Swallowing Exercise Group |
|---|---|
| Mean | 60.12 ± 12.34 |
| Sex: Female, Male(Participants) | Swallowing Exercise Group |
|---|---|
| Female | 6 |
| Male | 11 |
| Region of Enrollment(participants) | Swallowing Exercise Group |
|---|---|
| Brazil | 17 |
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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Federal University of Bahia