NCT06256874

Brief Summary

The goal of this clinical trial is to explore the impact of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals (≥60 year old) with swallowing disorders. It primarily aims to address the effects of Myofascial Release Training on swallowing function and quality of life in community-dwelling elderly individuals with swallowing disorders. All participants are required to undergo a continuous three-week (21 days) Myofascial Release Training, 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

57
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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 Feb 2024

Geographic Reach
1 country

2 active sites

Status
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

February 3, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 13, 2024

Completed
16 days until next milestone

Study Start

First participant enrolled

February 29, 2024

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

1 day

First QC Date

February 3, 2024

Last Update Submit

March 2, 2024

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

  • Swallowing-Related Quality of Life Questionnaire

    The Swallowing-Related Quality of Life Questionnaire (SWAL-QOL) is a validated tool used to assess the impact of swallowing difficulties on quality of life. It is a 44-item questionnaire designed to measure the physical, emotional, and social domains of swallowing-related quality of life.The higher final scores indicate the better life quality. The total score will be converted into a standard percentage

    day 1 and day 21

Secondary Outcomes (3)

  • Water Swallow Test

    day 1 and day 21

  • Time consumed in eating

    day 1 and day 21

  • Functional Oral Intake Scale

    day 1 and day 21

Study Arms (1)

the observation group

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 Myofascial Release Training, with weekends off and training conducted only on weekdays, two sessions per day, each lasting 15-30 minutes. Each training session will be conducted approximately one hour prior to meals. Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors

Behavioral: Myofascial Release Training

Interventions

Myofascial Release TrainingBEHAVIORAL

Myofascial release, also known as fascial release or fascial manipulation, is a physical therapy used to treat muscle and fascial tissue tension or pain. It involves applying appropriate pressure and stretching to release tight fascia and soft tissues, improving blood circulation, alleviating pain, and promoting rehabilitation. Myofascial release therapy is commonly used to treat muscle spasms, chronic pain, skeletal and joint issues, among others.

the observation 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.
  • Dysphagia

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

Study Sites (2)

Gaoxiong Rehabilitation Hospital

Xinzhu, Taiwan

RECRUITING

Hsinchu Rehabilitation Hospital

Xinzhu, Taiwan

RECRUITING

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 located in Miami

    STUDY CHAIR

Central Study Contacts

Hongji Zeng, Master

CONTACT

17695841016535226944@qq.com

Weiji Zhao, Master

CONTACT

17839973473zwjww2009@163.com

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

February 3, 2024

First Posted

February 13, 2024

Study Start

February 29, 2024

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

March 6, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)