- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06413407
Tai Chi Exercise and Receptive Music Therapy for the Elderly
May 9, 2024 updated by: NİHAN TÜRKOĞLU, Ataturk University
The Effect of Tai Chi Exercise and Receptive Music Therapy Applied to Elderly Individuals on Frailty Levels and Mental Health
Frailty has become a major public health issue with the global aging population.
In general, severe physical impairments and accompanying frailty in older adults are associated with adverse clinical outcomes.
In addition to physical disorders, psychosocial disorders are also important in the formation of frailty.
Depression is one of the most common psychosocial disorders among older adults, with prevalence ranging from 6.5% to 25.3%.
Frail people may develop depression, and depressive symptoms negatively affect the physical functioning of the body, contributing to the development of frailty.
This interrelationship between depression and frailty can lead to a vicious cycle with detrimental consequences for older adults.
It is reported in the literature that elderly individuals experience low levels of well-being as well as depression.
Spiritual well-being means that the individual is aware of his or her own abilities, feels at peace, is not affected by the stresses that may exist in his or her life, and is not in a state of spiritual turmoil.
Poor mental health in the elderly increases fragility.
This explains that frailty in elderly individuals affects all physical, social and psychological health components, and seriously negatively affects the quality of life and the formation and management of diseases.
Most of the research literature on frailty has focused on physical health.
But mental health, which includes positive aspects such as cognition, sleep, social interactions and well-being, is just as important as that related to physical illness and disability.
There is a serious need for similar research focusing on psychosocial interventions to prevent and manage frailty.
Studies are needed to show that promoting components such as resilience, social participation, and emotional regulation reduces stress levels in older adults, positively impacts mental health, increases healthy behaviors, and improves lifestyle, thereby reducing the risk of frailty.
When the literature is evaluated, scientific studies in which music therapy and physical activity are applied have shown that these methods have positive effects on conditions that negatively affect mental health such as anxiety, stress and depression.
There are no studies in the literature that discuss relaxing exercise and music therapy together for frailty in the elderly.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
The aim of this study is to determine the effect of relaxing exercise and music therapy on the level of fragility and mental health in the elderly, who are considered to be a risk group in terms of public health.
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nihan Türkoğlu
- Phone Number: +904422312689
- Email: nihan-25-kilic@hotmail.com
Study Contact Backup
- Name: Nihan Türkoğlu
- Phone Number: 05315740889
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Being 65 years or older
- Not having any obstacle to exercise
- He has no problems with his hearing
Exclusion Criteria:
- Not volunteering to participate in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Tai Chi Exercise Group
As an intervention for this group, only Tai Chi Exercise will be applied.
|
Tai Chi Exercise will be applied to this group.
|
Active Comparator: Receptive Music Therapy Group
As an intervention for this group, only Receptive Music Therapy Group will be applied.
|
Receptive Music Therapy will be applied to this group.
|
Experimental: Experimental
As an intervention, both Tai Chi Exercise and Receptive Music Therapy will be applied to this group.
|
Tai Chi Exercise and Receptive Music Therapy techniques will be applied together to this group.
|
No Intervention: Control
No intervention will be applied to this group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression, Anxiety, Stress Scale (DASS-21)
Time Frame: two week
|
The four-point Likert-type scale developed by Lovibond and Lovibond (1995) consists of 14 depression, 14 anxiety and 14 stress dimensions; The short form of the scale, which consists of seven items each, consists of 21 items in order to have faster and more effective access to resources and more qualified use of time.
It is presented in a four-point Likert form as "Not at All Appropriate (0) Somewhat Appropriate (1) Generally Appropriate (2) Completely Appropriate (4)" and shows that as the scores obtained from the scale increase, depression, anxiety and stress symptoms increase.
Turkish validity and reliability studies were carried out by Yılmaz et al.
Considering the reliability values, Cronbach's Alpha values for the dimensions are between 0.75-0.82;
It is seen that the factor load Omega values for the dimensions are between 0.76 and 0.82 (Yılmaz et al., 2017).
|
two week
|
Edmonton Frail Scale
Time Frame: Two week
|
In order to evaluate frailty in the elderly, Rolfson et al.
The validity and reliability study of the scale developed by Aygör in our country was carried out by Aygör.
The scale consists of 11 questions and is evaluated in the range of 0-20 points.
If the score obtained from the scale is in the range of 0-4, the elderly person is not fragile; A score of 5-6 is considered visibly vulnerable, a score of 7-8 is considered slightly fragile, a score of 9-10 is considered moderately fragile, and a score of 11 and above is considered severely fragile.
In Aygör's study, the Cronbach alpha coefficient was determined as 0.75.
|
Two week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nihan Türkoğlu, Atatürk Üniversitesi
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 15, 2024
Primary Completion (Estimated)
August 15, 2024
Study Completion (Estimated)
December 15, 2024
Study Registration Dates
First Submitted
May 9, 2024
First Submitted That Met QC Criteria
May 9, 2024
First Posted (Actual)
May 14, 2024
Study Record Updates
Last Update Posted (Actual)
May 14, 2024
Last Update Submitted That Met QC Criteria
May 9, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- NihanT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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