NCT06413407

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 14, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

May 9, 2024

Last Update Submit

May 9, 2024

Conditions

Keywords

Tai Chi ExerciseReceptive Music TherapyElderlyVulnerabilityDepression

Outcome Measures

Primary Outcomes (2)

  • 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).

    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.

    Two week

Study Arms (4)

Tai Chi Exercise Group

ACTIVE COMPARATOR

As an intervention for this group, only Tai Chi Exercise will be applied.

Behavioral: Tai Chi Exercise

Receptive Music Therapy Group

ACTIVE COMPARATOR

As an intervention for this group, only Receptive Music Therapy Group will be applied.

Behavioral: Receptive Music Therapy

Experimental

EXPERIMENTAL

As an intervention, both Tai Chi Exercise and Receptive Music Therapy will be applied to this group.

Behavioral: Experimental

Control

NO INTERVENTION

No intervention will be applied to this group.

Interventions

Tai Chi Exercise will be applied to this group.

Tai Chi Exercise Group

Receptive Music Therapy will be applied to this group.

Receptive Music Therapy Group
ExperimentalBEHAVIORAL

Tai Chi Exercise and Receptive Music Therapy techniques will be applied together to this group.

Experimental

Eligibility Criteria

Age65 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being 65 years or older
  • Not having any obstacle to exercise
  • He has no problems with his hearing

You may not qualify if:

  • Not volunteering to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Motor ActivityDepression

Interventions

Aquatic Therapy

Condition Hierarchy (Ancestors)

BehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitation

Study Officials

  • Nihan Türkoğlu

    Ataturk University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nihan Türkoğlu

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist Prof.

Study Record Dates

First Submitted

May 9, 2024

First Posted

May 14, 2024

Study Start

May 15, 2024

Primary Completion

August 15, 2024

Study Completion

December 15, 2024

Last Updated

May 14, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share