Dysphagia, EsophagealNCT06173388
Exercise Training for Cervicogenic Dysphagia
A study testing Structured exercise training program + The swallow resistance exercise program. and Only the swallow resistance exercise program. in people with Dysphagia, Esophageal, run by Umm Al-Qura University at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 35 to 50 years
- Conditions the study is for
- Dysphagia, Esophageal
- What is being tested?
- Structured exercise training program + The swallow resistance exercise program. and Only the swallow resistance exercise program.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2022to 20 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Patients with unstable cardiopulmonary or psychological disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Structured Exercise Training Program on Swallowing and Ventilatory Functions in Patients With Cervicogenic Dysphagia
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.
Read the detailed 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.
- Conditions
- Dysphagia, Esophageal
- Being tested
- Structured exercise training program + The swallow resistance exercise program., Only the swallow resistance exercise program.
- Keywords
- Deglutition Disorders, Pulmonary Functions, Manipulation, Physical Therapy
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured exercise training program + The swallow resistance exercise program.Other
Also called Intervention for the study group.
Structured exercise training program + The swallow resistance exercise program.
Only the swallow resistance exercise program.Other
Also called Intervention for the control group.
Only the swallow resistance exercise program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Only the swallow resistance exercise program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
The pulmonary functions including the forced vital capacity and the forced expiratory volume in one second were evaluated using the portable spirometer.
The pulmonary functions are usually expressed as percentages of predicted normal values %.
Measured: he pulmonary functions were evaluated initially at the at beginning of the study and at the end of the study (8-weeks interval).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Feb 2022
- Primary completion20 Jan 2023
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, EsophagealStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umm Al-Qura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Abdelaal, Umm Al-Qura University
- Investigators
- Ashraf Abdelaal, Ph.D., Principal investigator, Umm Al-Qura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173388
- Sponsor's protocol ID
- HAPO-02-K-012-202
- Status last verified
- Sep 2025
- First submitted
- 21 Feb 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Structured Exercise Training Program on Swallowing and Ventilatory Functions in Patients With Cervicogenic Dysphagia
- ClinicalTrials.gov ID
- NCT06173388
- Acronym / sponsor ID
- HAPO-02-K-012-202
- Conditions
- Dysphagia, Esophageal
- Keywords
- Deglutition Disorders, Pulmonary Functions, Manipulation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Umm Al-Qura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 15 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The structured exercise training program | Experimental | Other: Structured exercise training program + The swallow resistance exercise program., Other: Only the swallow resistance exercise program.Th study group received the structured exercise training program (composed of cervical stretching, strengthening and stabilizing exercises) plus the swallow resistance exercise. |
| The swallow resistance exercise | Other | Other: Only the swallow resistance exercise program.The control group: received only the swallow resistance exercise. |
Who may qualify
- Ages
- 35 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients with unstable cardiopulmonary or psychological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Structured exercise training program + The swallow resistance exercise program.Also: Intervention for the study group.Structured exercise training program + The swallow resistance exercise program. | Other | The structured exercise training program |
| Only the swallow resistance exercise program.Also: Intervention for the control group.Only the swallow resistance exercise program. | Other | The structured exercise training program, The swallow resistance exercise |
Primary outcome
Change from the baseline swallowing function at 8-weeks.
Time frame: 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.
Time frame: 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.
1 secondary outcome
Change in the pulmonary functions
Time frame: he pulmonary functions were evaluated initially at the at beginning of the study and at the end of the study (8-weeks interval).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf Abdelaal, Ph.D. principal investigator
Umm Al-Qura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured exercise training program + The swallow resistance exercise program. and Only the swallow resistance exercise program. in people with Dysphagia, Esophageal, run by Umm Al-Qura University at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline swallowing function at 8-weeks. (time frame: The swallowing function change was evaluated at the beginning of the study and after treatment completion (after 8 intervention weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.