Bellur 2012.
Study characteristics | ||
Methods |
Study design: parallel, RCT. Recruitment period: November 2010 – June 2012. Duration of study: study start date: November 2010. Actual study completion date: June 2012. Study setting: outpatient. Hacettepe University Faculty of Physical Therapy and Rehabilitation Cardiopulmonary Rehabilitation Department. Ankara, Turkey. |
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Participants |
Key inclusion criteria: mild, moderate and severe patients with OSA who did not use CPAP, aged 19‐75 years. Key exclusion criteria: participants with a history of stroke, neurological disease, severe obstructive nasal disease and infection history in the last month, or BMI was 40 kg /m2 or more. Age (years): mean (SD): 53.7 (7.1) in oropharyngeal exercises group and 47.3 (7.3) in standard medical treatment control group. Gender: for participants that ended the study: therapy group: 11 men and 3 women; control group: 10 men and 2 women. Comorbidities: not stated. BMI: mean (SD): 31.4 (3.8) in oropharyngeal exercises group and 32.1 (3.7) in standard medical treatment control group. AHI (events/hour): not available. ESS: mean (SD): 8.1 (6.3) in oropharyngeal exercises group and 9.7 (5.9) in control group. PSQI: mean (SD): not available. N randomised: 36, 18 to each group. N analysed: 26. Dropouts: 4 in oropharyngeal exercises group and 6 in standard medical treatment control group. |
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Interventions |
Intervention: oropharyngeal exercises. Same set of oropharyngeal exercises used by Guimaraes (see NCT00660777 Guimaraes 2009). 5 days a week for 3 months supervised by physical therapist. Used mirror for visual feedback. Comparator: standard medical treatment. Concomitant interventions: none. |
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Outcomes |
Prespecified outcomes: protocol not available. Reported outcomes:
Time points of measurement: 3 months. |
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Notes | Publication: abstract from conference proceedings only. Additional information requested and received from authors on allocation procedures. Funding for trial: not reported. Conflicts of interest: none. Registered: not reported. Sample size calculations: not reported. Data sharing statement: none. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation with closed envelopes. |
Allocation concealment (selection bias) | Low risk | Randomisation with closed envelopes. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded study. |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded study. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Similar percentages of losses to follow‐up in both groups. |
Selective reporting (reporting bias) | Low risk | Protocol not available. |
Other bias | Low risk | The study appears to be free of other sources of bias. |