NCT06303856

Brief Summary

The goal of this clinical trial is to explore the impact of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of dysphagia among community-dwelling elderly individuals, and 2) the effects of Active Breathing Exercises on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants enrolled are required to undergo a continuous three-week (21 days) Active Breathing Exercises, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 15-30 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
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 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

March 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

March 13, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 5, 2024

Last Update Submit

March 11, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Eating Assessment Tool-10

    Eating Assessment Tool-10 is a scale used to evaluate swallowing function problems, and is one of the commonly used tools for assessing the swallowing ability of elderly individuals. Eating Assessment Tool-10 stands for 'Eating Assessment Tool-10', and was developed by professional medical institutions in the United States with the aim of quickly assessing potential difficulties and problems during the process of swallowing.The Eating Assessment Tool-10 scale consists of 10 questions that cover different aspects of swallowing function. Each question has a rating score ranging from 0 to 4, indicating the severity of difficulty in swallowing, with 0 representing no problem and 4 representing severe difficulty. The higher the total score, the more severe the swallowing function problem. The scale ranges 0 - 40.

    day 1 and day 21

Secondary Outcomes (2)

  • Time consumed in eating

    day 1 and day 21

  • Swallowing-Related Quality of Life Questionnaire

    day 1 and day 21

Study Arms (1)

Active Breathing Exercises

EXPERIMENTAL

The observation group is the only group of the participants.The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Active Breathing Exercises, with weekends off and training conducted only on weekdays. Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors.

Behavioral: Active Breathing Exercises

Interventions

Active breathing exercises aim to enhance the strength and flexibility of respiratory muscles through a series of exercises, improving breathing patterns and increasing respiratory efficiency. The following are common components of active breathing exercises: 1) Deep Breathing. 2) Chest Expansion. 3) Diaphragmatic Breathing. 4) Coughing Techniques. 5) Expiratory Resistance Training. 6) Gradual Increase in Activity.

Active Breathing Exercises

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.

You may not qualify if:

  • Complicated with severe liver and kidney failure, tumors, or hematological disorders.
  • Physical disability.
  • Difficulty in mobility.

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

  • Nieto Luis, Master

    Site Coordinator of United Medical Group

    STUDY CHAIR

Central Study Contacts

Lavie Ce, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

March 5, 2024

First Posted

March 12, 2024

Study Start

March 1, 2024

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

March 13, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share