ElderlyNCT06413407
Tai Chi Exercise and Receptive Music Therapy for the Elderly
A study testing Tai Chi Exercise, Receptive Music Therapy and Experimental in people with Elderly and Exercise, run by Ataturk University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- What is being tested?
- Tai Chi Exercise, Receptive Music Therapy and Experimental
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2024to 15 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Being 65 years or older
- Not having any obstacle to exercise
- He has no problems with his hearing
Who cannot join
- Not volunteering to participate in the study
Trial locations and contacts
No sites are listed yet.
Nihan Türkoğlu contact
About this study
Official title: 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.
Read the 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.
- Being tested
- Tai Chi Exercise, Receptive Music Therapy, Experimental
- Keywords
- Tai Chi Exercise, Receptive Music Therapy, Elderly, Vulnerability, Depression
- Medical subject headings
- Motor Activity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ExerciseBehavioural
Tai Chi Exercise will be applied to this group.
Receptive Music TherapyBehavioural
Receptive Music Therapy will be applied to this group.
ExperimentalBehavioural
Tai Chi Exercise and Receptive Music Therapy techniques will be applied together to this group.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi Exercise Group | Active comparator | As an intervention for this group, only Tai Chi Exercise will be applied. Receives: Behavioral: Tai Chi Exercise |
| Receptive Music Therapy Group | Active comparator | As an intervention for this group, only Receptive Music Therapy Group will be applied. Receives: Behavioral: Receptive Music Therapy |
| Experimental | Experimental | As an intervention, both Tai Chi Exercise and Receptive Music Therapy will be applied to this group. Receives: Behavioral: Experimental |
| Control | No intervention | No intervention will be applied to this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety, Stress Scale (DASS-21)
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).
Measured: two week
Edmonton Frail Scale
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.
Measured: Two week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start15 May 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NİHAN TÜRKOĞLU, Ataturk University
- Investigators
- Nihan Türkoğlu, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413407
- Sponsor's protocol ID
- NihanT
- Status last verified
- May 2024
- First submitted
- 9 May 2024
- Last updated
- 14 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Tai Chi Exercise and Receptive Music Therapy Applied to Elderly Individuals on Frailty Levels and Mental Health
- ClinicalTrials.gov ID
- NCT06413407
- Acronym / sponsor ID
- NihanT
- Keywords
- Tai Chi Exercise, Receptive Music Therapy, Elderly, Vulnerability, Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 14 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tai Chi Exercise Group | Active comparator | Behavioral: Tai Chi ExerciseAs an intervention for this group, only Tai Chi Exercise will be applied. |
| Receptive Music Therapy Group | Active comparator | Behavioral: Receptive Music TherapyAs an intervention for this group, only Receptive Music Therapy Group will be applied. |
| Experimental | Experimental | Behavioral: ExperimentalAs an intervention, both Tai Chi Exercise and Receptive Music Therapy will be applied to this group. |
| Control | No intervention | –No intervention will be applied to this group. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Being 65 years or older
- Not having any obstacle to exercise
- He has no problems with his hearing
Key exclusion criteria (1 listed)
- Not volunteering to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi ExerciseTai Chi Exercise will be applied to this group. | Behavioural | Tai Chi Exercise Group |
| Receptive Music TherapyReceptive Music Therapy will be applied to this group. | Behavioural | Receptive Music Therapy Group |
| ExperimentalTai Chi Exercise and Receptive Music Therapy techniques will be applied together to this group. | Behavioural | Experimental |
Primary outcome
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nihan Türkoğlu contact
Nihan Türkoğlu principal investigator
Ataturk University
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi Exercise, Receptive Music Therapy and Experimental in people with Elderly and Exercise, run by Ataturk University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nihan Türkoğlu (+904422312689, nihan-25-kilic@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression, Anxiety, Stress Scale (DASS-21) (time frame: two week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2024.