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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Tai Chi Exercise Group
As an intervention for this group, only Tai Chi Exercise will be applied.
Behavioral: Tai Chi Exercise
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.
Behavioral: Receptive Music Therapy
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.
Behavioral: Experimental
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ataturk University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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