Exercise Training for Cervicogenic Dysphagia

Dysphagia, Esophageal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06173388
• Other study ID #: HAPO-02-K-012-202
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: December 2023
• Source: Umm Al-Qura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Postural correction therapeutic approaches are essential components in the dysphagia management program, but current evidence about their efficacy in dysphagia treatment is still limited. Although it is difficult to achieve a complete cervicogenic dysphagia cure; conservative therapies targeting postural realignment can alleviate the symptoms and treat cervicogenic dysphagia.

Definitely, there is a confirmed correlation between cervical spine pathologies and oropharyngeal dysphagia, further research is warranted to further explore the efficacy of the different rehabilitative non-surgical approaches in the treatment of cervicogenic dysphagia.

The objective of this study was to explore the efficacy of the structured physical therapy treatment program on pulmonary function, swallowing difficulty, and craniovertebral angle in patient with cervicogenic dysphagia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 50 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• Patients with unstable cardiopulmonary or psychological disorders.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Esophageal

Intervention

Other:
• Structured exercise training program + The swallow resistance exercise program.
Structured exercise training program + The swallow resistance exercise program.
• Only the swallow resistance exercise program.
Only the swallow resistance exercise program.

Locations

Country	Name	City	State
Saudi Arabia	Umm Al-Qura University	Mecca

Sponsors (1)

Lead Sponsor	Collaborator
Umm Al-Qura University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline swallowing function at 8-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 function change was evaluated at the beginning of the study and after treatment completion (after 8 intervention weeks)
Primary	Change in the forward head position (through the craniovertebral angle value) was evaluated at 8-weeks.	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 head position change was evaluated initially at the at beginning of the study and at the end of the study (8-weeks interval).
Secondary	Change in the pulmonary functions	The pulmonary functions including the forced vital capacity and the forced expiratory volume in one second was evaluated using the portable spirometer.	he pulmonary functions were evaluated initially at the at beginning of the study and at the end of the study (8-weeks interval).