Respiratory Muscle Strength Training in Presbyphonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Post-Treatment Mean in Voice Handicap Index Score
研究概览
简要总结
Presbyphonia is an age-related voice disorder that affects more than 10 million people in the United States. Presbyphonia is characterized by vocal fold atrophy that impairs older individuals' ability to communicate, leading to social isolation and reduced quality of life. Outcomes from current treatment approaches are often suboptimal for patients with presbyphonia as they do not sufficiently challenge the respiratory system to induce meaningful change. It is highly likely that the addition of respiratory training would result in greatly improved outcomes, such as the ability to speak loud and long enough to have a normal conversation. The purpose of this study will be to examine the effect of adding inspiratory muscle strength training (IMST) or expiratory muscle strength training (EMST) to standard of care voice therapy on respiratory and voice outcomes in patients with an age-related voice disorder.
Forty-eight participants diagnosed with presbyphonia will be blocked-randomized into three intervention groups, using a 3-parallel arm design: IMST and voice exercises, EMST and voice exercises, and voice exercises during all session. Study endpoints will be the change in voice and respiratory measures after four treatment sessions compared to baseline values. Response to treatment will be analyzed to determine if there are subgroups of high- or low-responders based on baseline voice and respiratory characteristics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Perceptual ratings of voice quality and of videostroboscopic images of the larynx will be rater by external judges, who will be blinded to the group assignment and to the assessment time (pre or post treatment).
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must receive a diagnosis of presbyphonia by a trained laryngologist. The diagnosis will be given following a visual examination if the observations are consistent with the characteristics of a presbylarynx, as judged by the laryngologist.
- •must be 50 years old and older.
排除标准
- •has received voice therapy in the past year
- •presents with a vocal fold pathology other than presbyphonia
- •has a known neurologic or a progressive neuromuscular disease
- •has a medical condition that could be aggravated by the experimental intervention, or any condition judged by the physician (Dr. Halstead) as being unsuitable for RMST.
- •has dysarthria or a language disorder
- •has a hearing loss that is not adequately managed
- •has a cognitive disorder that might affect treatment compliance
- •is unable to give informed consent
结局指标
主要结局
Post-Treatment Mean in Voice Handicap Index Score
时间窗: up to 5 weeks after baseline
Voice Handicap Index-10 (ordinal scale that measures the degree of handicap a person experiences because of their voice disorder. Minimum score 0, maximal score 40. A lower score is better )
次要结局
- Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)(up to 5 weeks after baseline)
- Post-treatment Mean in Overall Severity of Voice Quality(up to 5 weeks after baseline)
- Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score(up to 5 weeks after baseline)
- Post-treatment Mean in Average Subglottal Pressure(up to 5 weeks after baseline)
- Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)(up to 5 weeks after baseline)
- Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)(up to 5 weeks after baseline)
- Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)(up to 5 weeks after baseline)
- Post-treatment Mean in (Habitual) Sound Pressure Level(up to 5 weeks after baseline)
- Post-treatment Mean in Baseline Bowing Index(up to 5 weeks after baseline)
- Post-treatment Mean in Aerodynamic Resistance(up to 5 weeks after baseline)
- Post-treatment Mean in Average Glottal Airflow(up to 5 weeks after baseline)
- Post-treatment Mean in Forced Vital Capacity (FVC)(up to 5 weeks after baseline)
- Post-treatment Mean in Glottal Function Index (GFI) Score(up to 5 weeks after baseline)
- Post-treatment Mean in Maximum Expiratory Pressure (MEP)(up to 5 weeks after baseline)
- Post-Treatment Mean for FEV1/FVC(up to 5 weeks after baseline)
- Post-treatment Mean in Maximum Inspiratory Pressure (MIP)(up to 5 weeks after baseline)