NCT07049471

Brief Summary

This clinical trial aimed to evaluate the effectiveness of a structured swallowing exercise and maneuver program for older adults with dysphagia living in a nursing home. Dysphagia, or difficulty in swallowing, is common in elderly populations and may lead to malnutrition, dehydration, and aspiration pneumonia. In this study, 72 participants aged 60 years and older were randomly assigned to either an intervention group or a control group. The intervention group received a combined swallowing exercise and maneuver program-including Masako Maneuver, Chin Tuck Against Resistance, Supraglottic Swallow, and Super-Supraglottic Swallow-performed three times daily before meals over a six-week period. The control group received standard care, including upright sitting posture during meals. Swallowing ability was measured using the EAT-10 questionnaire. The intervention group showed significant improvement in swallowing scores, while no meaningful changes were observed in the control group. This study suggests that nurse-led swallowing exercises can be a safe, simple, and effective strategy to improve swallowing function and quality of life in older adults living in long-term care settings.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 3, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

July 10, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

July 3, 2025

Status Verified

June 1, 2025

Enrollment Period

2 months

First QC Date

June 25, 2025

Last Update Submit

June 25, 2025

Conditions

Keywords

Oropharyngeal Dysphagiaolder adultnursing homeswallowing

Outcome Measures

Primary Outcomes (2)

  • Improvement in Swallowing Function Measured by EAT-10 Score

    Swallowing function is assessed using the Eating Assessment Tool-10 (EAT-10), a validated 10-item self-report questionnaire for identifying symptoms of dysphagia. Each item is scored from 0 (no problem) to 4 (severe problem), with a total possible score ranging from 0 to 40. A score of 3 or more indicates clinically significant dysphagia. The primary outcome is the change in EAT-10 scores from baseline (prior to intervention) to the end of the 6-week intervention period. A decrease in score reflects improvement in swallowing function.

    Baseline (Day 0) and Week 6 (Post-intervention)

  • Change in Swallowing Function as Measured by EAT-10 Score

    Swallowing function was assessed using the Eating Assessment Tool-10 (EAT-10), a validated 10-item questionnaire designed to identify symptoms of dysphagia. Each item is scored on a 5-point Likert scale (0-4), with total scores ranging from 0 to 40. A score ≥3 indicates clinically significant swallowing difficulty. The primary outcome is the change in total EAT-10 score from baseline (pre-intervention) to the end of the 6-week intervention period. A greater reduction in the EAT-10 score indicates an improvement in swallowing function.

    Baseline and 6 weeks after intervention initiation

Study Arms (2)

Swallowing Exercise and Maneuver Group

EXPERIMENTAL

Participants in this arm received a structured swallowing exercise and maneuver program consisting of four techniques: Masako Maneuver, Chin Tuck Against Resistance (CTAR), Supraglottic Swallow, and Super-Supraglottic Swallow. The exercises were administered by nurses using a video-guided protocol, three times daily before meals for six weeks. The program was designed to improve pharyngeal muscle strength and enhance airway protection during swallowing.

Behavioral: Swallowing Exercise and Maneuver Program for Older Adults with Dysphagia

Standard Care Group

NO INTERVENTION

Participants in this arm received standard care for dysphagia, which involved upright sitting positioning during meals without any structured swallowing exercises or maneuvers. No additional behavioral interventions were provided during the study period.

Interventions

The intervention is a structured swallowing exercise and maneuver program designed specifically for older adults with oropharyngeal dysphagia in nursing homes. It combines four evidence-based techniques: Masako Maneuver, Chin Tuck Against Resistance (CTAR), Supraglottic Swallow, and Super-Supraglottic Swallow. The program was delivered by nurses using video-guided instructions and was conducted three times daily before meals for six weeks. Unlike interventions targeting post-stroke dysphagia, this program focuses on non-stroke-related swallowing difficulties in frail elderly populations residing in long-term care facilities.

Swallowing Exercise and Maneuver Group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 60 years or older
  • experiencing swallowing difficulties as assessed by the Eating Assessment Tool-10 (EAT-10)
  • having no history of neurological disease
  • possessing adequate communication abilities
  • and being capable of performing daily activities either independently or with partial assistance

You may not qualify if:

  • individuals with dermatological conditions in the anterior neck region, hypertension, orofacial pain such as trigeminal neuropathy or toothache, as well as those with significant malocclusion or facial asymmetry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Nursing Universitas Indonesia

Depok, West Java, 16424, Indonesia

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Aging

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Central Study Contacts

Etty Rekawati, Doctor of Nursing

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study used a randomized, parallel-group design involving two arms: an intervention group receiving a structured swallowing exercise and maneuver program, and a control group receiving standard care. Participants were randomly assigned using a simple random sampling technique. The intervention was administered three times daily for six weeks. Outcomes were compared between groups to evaluate the effectiveness of the intervention on swallowing function in older adults with oropharyngeal dysphagia living in a nursing home.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator of the Clinical Trial

Study Record Dates

First Submitted

June 25, 2025

First Posted

July 3, 2025

Study Start

July 10, 2025

Primary Completion

August 31, 2025

Study Completion

August 31, 2025

Last Updated

July 3, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will share

Individual Participant Data (IPD) will be shared upon reasonable request for academic or scientific purposes.

Shared Documents
STUDY PROTOCOL

Locations