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临床试验/NCT06173388
NCT06173388已完成不适用

Efficacy of Structured Exercise Training Program on Swallowing and Ventilatory Functions in Patients With Cervicogenic Dysphagia

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Change from the baseline swallowing function at 8-weeks.

研究概览

简要总结

Background: Cervicogenic dysphagia is a swallowing difficulty caused by cervical problems that negatively impact pulmonary health, and quality of life and may increase the risk of mortality.

Study design: Randomized Controlled Study Purpose: The purpose was to explore the effect of a structured exercise training program composed of cervical stretching, strengthening and stabilizing exercises on the swallowing function, craniovertebral angle, and pulmonary function in patient with cervicogenic dysphagia.

Methods: 32 patients (age 35-50 years) with cervicogenic dysphagia were randomly allocated into study group (n=17) and control group (n=15). The craniovertebral angle (CVA), the swallowing function (using the swallow-difficulty questionnaire "SDQ") and the pulmonary function (including the forced vital capacity "FVC" and forced expiratory volume in one second "FEV1") were evaluated pre-study and post-study. All participants received three sessions/week for 8-weeks. The study group received the structured exercise program, in addition to the swallow resistance exercise (SRE), while the control group received the swallow resistance exercise only.

详细描述

Dysphagia is a common complaint in patients with cervical problems, and it is usually transient and responds favorably to rehabilitation programs. Cervicogenic dysphagia is difficulty in swallowing due to cervical spine pathology. Considering the close proximity of the cervical spine to the oropharynx and esophagus; the existence of any cervical pathology can adversely impact the pharynx and esophagus dimensions, through direct compression on the esophagus resulting in epiglottic tilt, cricopharyngeal spasm, and disturbed laryngeal inlet closure pattern, ending in disturbing the normal swallowing that can be evaluated by the swallowing disturbance questionnaire results in which the lower scores on the swallowing difficulty questionnaire reflects better swallowing status than higher scores, furthermore; with the cut-off value for 12.5 is a good predictor of the disturbed swallowing function.

Cervical malalignment is associated with an increased incidence of dysphagia. Cervical kyphosis is associated with malfunctional pharyngeal structure and disturbed swallowing. Additionally; cervical kyphosis is associated with deep cervical flexor muscles' weakness that in turn can significantly disturb cervical stability during swallowing. The combined effect of muscle weakness and poor cervical posture negatively impacts the laryngeal and cricopharyngeal sphincteric action and ends in cervical kyphosis.

Disturbed swallowing can negatively impact respiratory function, causing rapid deterioration in patients' ventilatory function and increasing the rate of pulmonary disorders' exacerbations. Maintaining normal swallowing function is essential in preventing consequent pulmonary complications.

Mal-aligned cervical spine predisposes to altered pulmonary functions that can be successfully corrected with therapeutic exercises, and manual therapy approaches.

A proper dysphagia management program is important not only to restore the normal coordinated swallowing-breathing pattern; but also, to eliminate the dysphagia-associated morbidity and health-related economic burden. Since cervicogenic dysphagia results from cervical spine pathologies or deformities, management of cervicogenic dysphagia should be focused on the treatment of cervical disturbances.

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)

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants with cervicogenic dysphagia,
  • Age 35-50 years,
  • Patients with forward head posture (the craniovertebral angle ≤ 49 degree),
  • Patients who agreed to sign the written consent.

排除标准

  • - Patients with unstable cardiopulmonary or psychological disorders.

结局指标

主要结局

Change from the baseline swallowing function at 8-weeks.

时间窗: The swallowing function change was evaluated at the beginning of the study and after treatment completion (after 8 intervention weeks)

The change in the swallowing function was evaluated across the 8 weeks period using the swallowing disturbance questionnaire. The swallowing function change was evaluated by assessing the swallowing function at the beginning of the study and at the end of the study (8 weeks interval). The swallowing disturbance questionnaire score greater than 12.5 indicates the presence of swallowing disturbances, with a high score reflecting increased dysphagia severity.

Change in the forward head position (through the craniovertebral angle value) was evaluated at 8-weeks.

时间窗: The head position change was evaluated initially at the at beginning of the study and at the end of the study (8-weeks interval).

The forward head position was evaluated across the 8-weeks period using the craniovertebral angle, defined between the horizontal line crossing the 7th cervical vertebra and second line extending from the 7th cervical vertebra to the ear tragus. The smaller craniovertebral angle is associated with greater forward head position, with the craniovertebral angle of ≤ 49 degrees suggesting the presence of forward head position.

Change from the baseline swallowing function at 8-weeks.

时间窗: The swallowing function change was evaluated at the beginning of the study and after treatment completion (after 8 intervention weeks)

The change in the swallowing function was evaluated across the 8 weeks period using the swallowing disturbance questionnaire. The swallowing function change was evaluated by assessing the swallowing function at the beginning of the study and at the end of the study (8 weeks interval). The swallowing disturbance questionnaire score greater than 12.5 indicates the presence of swallowing disturbances, with a high score reflecting increased dysphagia severity.

Change in the forward head position (through the craniovertebral angle value) was evaluated at 8-weeks.

时间窗: The head position change was evaluated initially at the at beginning of the study and at the end of the study (8-weeks interval).

The forward head position was evaluated across the 8-weeks period using the craniovertebral angle, defined between the horizontal line crossing the 7th cervical vertebra and second line extending from the 7th cervical vertebra to the ear tragus. The smaller craniovertebral angle is associated with greater forward head position, with the craniovertebral angle of ≤ 49 degrees suggesting the presence of forward head position.

次要结局

  • Change in the pulmonary functions(he pulmonary functions were evaluated initially at the at beginning of the study and at the end of the study (8-weeks interval).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ashraf Abdelaal

Principal Investigator

Umm Al-Qura University

研究点 (1)

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