Clinical trial NCT06370390: Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia
Official title: Community-based Group Rehabilitation Program for Stroke Patients With Dysphagia: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Chao Phya Abhaibhubejhr Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Detailed description: Stroke is complicated by oropharyngeal dysphagia in 29 to 81% of patients. Up to 40% of these individuals continue to experience swallowing difficulty even after a year later, which is associated with an increased risk of consequences such as aspiration pneumonia, dehydration, and malnutrition.

Community-based exercise programs have demonstrated potential for implementation in older adults; however, it remains imperative to ascertain whether this strategy will yield comparable benefit in stroke patients with dysphagia.Participants were randomly assigned to either the intervention group or the control group. Patients in the intervention group received swallowing function training in community public spaces for 5 days every week for four-week period (60 minutes per day). Patients in the control group received no intervention. Penetration-Aspiration Scale and Standardized Swallowing Assessment (SSA), depressive symptoms (Geriatric Depression Scale-15), and meal duration were assessed before and after all the treatment.

Eligibility criteria: Inclusion Criteria:

* Age over 65 years old.
* No hospitalization within the past six months.
* With clear consciousness and able to cooperate with questionnaires and training.
* The elderly people who voluntarily participate and agree to adhere until the end of the study.
* early dysphagia.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Physical disability.
* Simultaneously receiving other therapies that might influence this study.
* Individuals with a gastrostomy.
* Abnormalities of the oral, pharyngeal, or esophageal structures.

Primary outcomes:
measure: Standardized Swallowing Assessment Scale
timeFrame: day 1 and day 28
Secondary outcomes:
measure: Time consumed in eating
timeFrame: day 1 and day 28
measure: Penetration-Aspiration Scale
timeFrame: day 1 and day 28
measure: 15-item Geriatric Depression Scale
timeFrame: day 1 and day 28
Other outcomes:
Locations:
Study officials:
affiliation: Site Coordinator of United Medical Group located in Miami
name: Louis Wi
role: PRINCIPAL_INVESTIGATOR
References: