NCT06393283

Brief Summary

The goal of this clinical trial is to explore the Diaphragm Training on swallowing function in Elderly Nursing Home Residents (≥60 year old) with swallowing disorders. It primarily aims to address: the effects of Diaphragm Training on swallowing function and quality of life in Elderly Nursing Home Residents. All participants are divided into 2 groups. The intervention group is required to undergo a continuous three-week (21 days) Diaphragm Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

April 1, 2024

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 27, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

April 27, 2024

Last Update Submit

April 27, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gugging Swallowing Screen

    The Gugging Swallowing Screen is used to assess dysphagia. The Screen consists of 10 items covering various aspects of swallowing, including oral and pharyngeal muscle function, oral sensation, tongue coordination, and more. The total scores range from 1 to 20, with lower scores indicating more severe dysphagia.

    day 1 and day 21

Secondary Outcomes (4)

  • Time consumed in eating

    day 1 and day 21

  • Swallowing-Related Quality of Life Questionnaire

    day 1 and day 21

  • Dysphagia Handicap Index

    day 1 and day 21

  • Eating Assessment Tool-10

    day 1 and day 21

Study Arms (2)

the intervention group

EXPERIMENTAL

Diaphragm Training will be given twice a day and 30min per time.

Behavioral: Diaphragm Training

the blank group

NO INTERVENTION

No intervention will be applied.

Interventions

Diaphragm training includes both active and passive methods. Passive training involves placing weights on the participant's abdomen to provide resistance during breathing. Active training involves instructing participants to practice diaphragmatic breathing techniques.

the intervention group

Eligibility Criteria

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

You may qualify if:

  • Age over 60 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 caused by sarcopenia.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesPharyngeal DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Louis Wi

    Site Coordinator of United Medical Group

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

April 27, 2024

First Posted

May 1, 2024

Study Start

April 1, 2024

Primary Completion

June 1, 2024

Study Completion

June 1, 2024

Last Updated

May 1, 2024

Record last verified: 2024-04