Exercise Training for Cervicogenic Dysphagia

NCT06173388 | Completed DMC

• 1 other identifier: HAPO-02-K-012-202
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia, Esophageal

Keywords

Deglutition Disorders; Pulmonary Functions; Manipulation; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• 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 disturbance questionnaire score greater than 12.5 indicates the presence of swallowing disturbances, with a high score reflecting increased dysphagia severity.

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

• 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 smaller craniovertebral angle is associated with greater forward head position, with the craniovertebral angle of ≤ 49 degrees suggesting the presence of forward head position.

  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 Outcomes (1)

• 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).

Study Arms (2)

The structured exercise training program

EXPERIMENTAL

Th study group received the structured exercise training program (composed of cervical stretching, strengthening and stabilizing exercises) plus the swallow resistance exercise.

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

The swallow resistance exercise

OTHER

The control group: received only the swallow resistance exercise.

Other: Only the swallow resistance exercise program.

Interventions

Structured exercise training program + The swallow resistance exercise program. OTHER

Structured exercise training program + The swallow resistance exercise program.

Also known as: Intervention for the study group.

The structured exercise training program

Only the swallow resistance exercise program. OTHER

Only the swallow resistance exercise program.

Also known as: Intervention for the control group.

The structured exercise training program; The swallow resistance exercise

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- Patients with unstable cardiopulmonary or psychological disorders.

Sponsors & Collaborators

• Umm Al-Qura University: lead

Study Sites (1)

Umm Al-Qura University

Mecca, Saudi Arabia

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Ashraf Abdelaal, Ph.D.

  Umm Al-Qura University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: December 15, 2023
• Study Start: February 1, 2022
• Primary Completion: January 20, 2023
• Study Completion: May 20, 2023
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)