Clinical trial NCT06644690: Creative Dance-Supported CO-OP Approach in Older Adults With Mild Cognitive Impairment
Official title: The Effect of a Creative Dance-Supported CO-OP Approach on Executive Functions, Attention, Memory, and Dual-Task Performance in Older Adults With Mild Cognitive Impairment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Keywords: Cognitive Rehabilitation
Mild Cognitive Impairment
Executive Function
Creative Dance
Dual-Task Performance
Older Adults
CO-OP Approach
Lead sponsor: Çankırı Karatekin University
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 24
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: In this parallel-group randomized controlled trial, participants will be assigned to one of two groups. The first group will receive the CO-OP approach combined with creative dance, while the second group will receive only the CO-OP intervention. Both groups will participate in 8-week intervention programs, with sessions held three times a week. The outcomes of interest, such as improvements in executive functions, attention, memory, and dual-task performance, will be compared between the two groups at baseline, post-intervention, and follow-up assessments at 3 and 6 months.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to evaluate if the CO-OP (Cognitive Orientation to daily Occupational Performance) approach, supported by creative dance, can improve cognitive functions in older adults with mild cognitive impairment (MCI). The study focuses on the effects of this intervention on executive functions, attention, memory, and dual-task performance.

The main questions this study aims to answer are:

Does the CO-OP approach with creative dance improve executive functions, attention, and memory more than CO-OP alone? How effective is this intervention in enhancing dual-task performance compared to the standard CO-OP approach?

Participants will:

Engage in either the CO-OP intervention alone or the CO-OP approach combined with creative dance for 8 weeks.

Complete cognitive tasks, participate in creative dance activities, and perform daily tasks during the sessions.

Detailed description: This clinical trial aims to assess the effectiveness of a Cognitive Orientation to daily Occupational Performance (CO-OP) approach, enhanced with creative dance, in older adults with mild cognitive impairment (MCI). The CO-OP method is a cognitive rehabilitation strategy that helps individuals improve occupational performance through goal-setting, problem-solving, and the use of metacognitive strategies. In this study, the CO-OP approach will be integrated with creative dance movements, a form of physical and artistic expression known to stimulate both cognitive and motor functions.

The study will enroll 24 participants between the ages of 65 and 85, diagnosed with MCI according to DSM-5 criteria. Participants will be randomly assigned to two groups:

CO-OP with Creative Dance Group: This group will receive the CO-OP intervention along with creative dance sessions. The creative dance component will consist of simple movements designed to improve motor coordination, memory, and attention, all while fostering social interaction and emotional expression.

CO-OP Only Group: This group will undergo the CO-OP approach alone without any creative dance involvement.

The intervention will last for 8 weeks, with three 60-minute sessions each week. During the sessions, participants in the CO-OP with creative dance group will alternate between cognitive tasks and dance-based activities. The sessions are designed to progressively challenge cognitive and motor skills while ensuring safety and comfort for older adults.

The primary outcome measures include improvements in executive functions, attention, memory, and dual-task performance. Cognitive function will be assessed using standardized neuropsychological tests such as the Trail Making Test Part B (for executive function), Stroop Test (for attention), Rey-Osterrieth Complex Figure Test (for memory), and dual-task assessments combining walking with cognitive tasks. Participants' quality of life will be measured using the SF-36 Health Survey, and depression and social isolation will be evaluated through the Geriatric Depression Scale (GDS) and UCLA Loneliness Scale, respectively.

Secondary measures will focus on the potential emotional and social benefits of integrating creative dance into the CO-OP approach. These will include participant feedback on enjoyment and perceived improvements in social interaction and emotional well-being. The trial will also explore whether the addition of creative dance enhances motivation, engagement, and adherence to the intervention.

Data will be collected at baseline, at the end of the 8-week intervention, and again at 3 and 6 months post-intervention to evaluate both short-term and long-term effects. Statistical analysis will be conducted using repeated measures ANOVA to assess changes over time between groups.

This study is expected to provide insights into how integrating creative dance with the CO-OP approach can potentially offer a more holistic and effective intervention for older adults with MCI, addressing both cognitive and physical domains while also promoting social interaction and emotional health.

Eligibility criteria: Inclusion Criteria:

* Age between 65 and 85 years old
* Diagnosis of mild cognitive impairment (MCI) according to DSM-5 criteria
* Ability to participate in physical activities, including creative dance movements
* Willingness to attend all study sessions and follow-up assessments
* Able to give informed consent

Exclusion Criteria:

* Diagnosis of a major neurocognitive disorder (e.g., Alzheimer's disease)
* Presence of severe physical impairments that prevent participation in physical activity
* Current use of medications that significantly affect cognitive function
* Participation in another clinical trial within the past 3 months
* History of significant psychiatric disorders (e.g., major depression, schizophrenia)

Primary outcomes:
measure: Change in Executive Function as Measured by the Trail Making Test Part B
timeFrame: Baseline, immediately after the 8-week intervention, and at 3 and 6 months post-intervention
Secondary outcomes:
measure: Change in Attention as Measured by the Stroop Test
timeFrame: Baseline, immediately after the 8-week intervention, and at 3 and 6 months post-intervention
measure: Change in Memory Performance as Measured by the Rey-Osterrieth Complex Figure Test
timeFrame: Baseline, immediately after the 8-week intervention, and at 3 and 6 months post-intervention
measure: Change in Dual-Task Performance as Measured by Walking While Performing a Cognitive Task"
timeFrame: Baseline, immediately after the 8-week intervention, and at 3 and 6 months post-intervention
Other outcomes:
Locations:
city: Çankırı
country: Turkey
facility: Çankırı Karatekin University, Faculty of Health Sciences
state: Not Applicable For Türkiye
Study officials:
affiliation: Çankırı Karatekin University
name: Ceyhun Türkmen, PhD
role: PRINCIPAL_INVESTIGATOR
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