Ignite Creation Date:
2024-07-17 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490705
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2024-06-29
Brief Title:
The Efficacy of Tongue Exercises on Swallowing Function in the Elderly With Mild Cognitive Impairment
Sponsor:
Chang Gung Medical Foundation
Organization:
Chang Gung Medical Foundation
Study Overview
Official Title:
Chang Gung Memorial Hospital at Linkou
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to explore the effects of tongue muscle strength and resistance exercises on dysphagia tongue muscle strength oral hygiene repetitive saliva swallowing nutrition depression and swallowing-related quality of life in frail elderly people with mild cognitive impairment in the community
This is a longitudinal research design using cluster randomization Participants were randomly divided into three groups by computer Experimental Group 1 received tongue resistance exercises Experimental Group 2 received both tongue strengthening exercises and tongue resistance exercises and the control group received oral and cheek bulging exercises
This is a longitudinal research design using cluster randomization Participants were randomly divided into three groups by computer Experimental Group 1 received tongue resistance exercises Experimental Group 2 received both tongue strengthening exercises and tongue resistance exercises and the control group received oral and cheek bulging exercises
Detailed Description:
Recruitment was carried out in nursing homes day passport centers and community care centers in New Taipei City and Taoyuan City Taiwan The subjects were elderly people aged 65 years or older with cognitive impairment and frailty recruited from November 19 2021 to January 25 2024Participants were randomly divided into three groups by computer 30 people per group Group 1 received tongue resistance exercises Group 2 received both tongue strengthening exercises and tongue resistance exercises Group 3 control group received oral and cheek bulging exercises
The exercise intervention is divided into two stages After completing the pre-test T1 the first stage of 12 weeks of exercise begins with evaluations conducted at the 4th week T2 8th week T3 and 12th week T4 After a 12-week rest period T5 the second phase of Boosters exercise is conducted for another 12 weeks followed by an immediate post-test T6 and a final evaluation after another 12 weeks of rest T7 Participants received exercise 6 days a week 3 times a day before meals with each session lasting 30 minutes
Before conducting the study all participants received a complete explanation of the purpose risks and procedures of the investigation and provided written informed consent Procedures were in accordance with the ethical standards of the committee on human experimentation at the institution where the work was conducted and this study was approved by the Institutional Review Board
The exercise intervention is divided into two stages After completing the pre-test T1 the first stage of 12 weeks of exercise begins with evaluations conducted at the 4th week T2 8th week T3 and 12th week T4 After a 12-week rest period T5 the second phase of Boosters exercise is conducted for another 12 weeks followed by an immediate post-test T6 and a final evaluation after another 12 weeks of rest T7 Participants received exercise 6 days a week 3 times a day before meals with each session lasting 30 minutes
Before conducting the study all participants received a complete explanation of the purpose risks and procedures of the investigation and provided written informed consent Procedures were in accordance with the ethical standards of the committee on human experimentation at the institution where the work was conducted and this study was approved by the Institutional Review Board
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None