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临床试验/NCT04788238
NCT04788238Unknown不适用

Dual-Task Zumba Gold for Improving the Cognition of Community-Dwelling Older Adults With Mild Cognitive Impairment: A Pilot Randomized Controlled Trial

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年3月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
60
试验地点
1
主要终点
Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up)

研究概览

简要总结

The study aims to assess the preliminary efficacy of a Dual-Task Zumba Gold (DTZ) intervention that will support physical and cognitive training among community-dwelling persons with mild cognitive impairment (MCI). A 12-week Dual-Task Zumba Gold (DTZ) intervention will be implemented among 30 participants with MCI in the treatment group, while health education will be provided to another 30 subjects allocated in the control group. Changes in global cognitive function, together with the quality of life, mood, functional mobility, and bodily measures, will be re-assessed after the 12-week intervention and a 6-week follow-up period. Quantitative and qualitative methods will also be employed to assess the feasibility and acceptability outcomes of the study.

详细描述

Background: Dementia risk reduction is considered a public health priority. However, there is a paucity of related interventions among low- and middle-income countries (LMICs), such as the Philippines, despite the higher number of dementia cases in these regions. Meanwhile, individuals with mild cognitive impairment (MCI), being at risk for dementia, are important targets for interventions to promote cognitive health.

The enrichment of physical activities with cognitive exercises, known as dual-task training, is an innovative approach that has been noted to potentially improve cognitive outcomes in persons with MCI. Zumba is a popular dance worldwide, which combines rhythmic aerobic steps and whole-body movements. It has a modified version for older adults, called Zumba Gold, but information about its effects on older people is limited.

Literature states that ensuring sufficient cognitive load in complex motor activities is important to achieve significant and superior cognitive outcomes. Dual-Task Zumba Gold (DTZ), an intervention combining Zumba Gold and simultaneous cognitive training, and is a novel and inexpensive non-pharmacological intervention that may enhance the cognition of persons at risk for dementia. However, its feasibility and potential efficacy among older people with MCI are unknown.

Objectives of the Study: There are two objectives in this study: (1) To determine the feasibility and acceptability of a Dual-Task Zumba Gold (DTZ) intervention among community-dwelling individuals with MCI. (2) To investigate the preliminary efficacy of the DTZ intervention in improving the cognitive function among the recruited participants with MCI.

Methods: This is a mixed-method pilot study, involving quantitative and qualitative methods to evaluate the study outcomes. The proposed 12-week DTZ intervention will be conducted three times/week for 45-60 minutes among individuals with MCI. Cognitive domains of executive function, visuospatial ability, memory, and complex attention will be stimulated through mental exercises which will be performed concurrently with the dance steps during particular sequences of the Zumba Gold dance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Outcome assessors and data analysts will be blinded to the group allocation until the whole data analyses are completed. They will also not be involved in any part of the treatment administration. Furthermore, participants will be advised not to disclose their group assignment during data collection.

入排标准

年龄范围
55 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •subjective report/concern about changes in memory or cognition
  • •objective cognitive impairment, based on Montreal Cognitive Assessment (MoCA) score of ≤25
  • •absence of diagnosis of dementia or Alzheimer's disease
  • •normal function in daily activities, via Katz ADL scale score of 6
  • •ambulatory, without the need to use assistive devices
  • •able to read/communicate in the Filipino/English language

排除标准

  • •medical diagnosis of any form of neurological or psychiatric disorder
  • •uncontrolled or severe heart condition, cancer, major musculoskeletal disorder, psychiatric condition, serious hearing/visual impairment, or any condition that would limit study safety; or being at risk for adverse events to PA participation, assessed via the revised Physical Activity Readiness Questionnaire (rPARQ)
  • •intake of medications such as anti-depressants, sedatives, or anti-epileptics that may affect cognition
  • •participation in any organized physical activity program in the past 3 months

研究组 & 干预措施

Intervention group

Experimental

Participants in the intervention arm will participate in the dual-task Zumba Gold (DTZ) program. They will be grouped into 10 participants per class.

干预措施: Dual-Task Zumba Gold (Behavioral)

Control group

No Intervention

Participants in the control group will receive health education about dementia risk reduction provided by community health nurses.

结局指标

主要结局

Changes in Montreal Cognitive Assessment score (from baseline to 18 weeks follow-up)

时间窗: Baseline; 12 weeks; 18 weeks

Montreal Cognitive Assessment (MoCA) evaluates global cognition by involving multiple domains such as attention, memory, language, visuospatial skills, abstraction, calculation, and orientation. The scores range from 0 to 30, with higher scores indicating better cognitive performance.

Changes in Digit Span test (from baseline to 18 weeks follow-up)

时间窗: Baseline; 12 weeks; 18 weeks

In Digit Span Test, numbers are read to the participant at a rate of one per second and then later asked to repeat them in a forward and backward manner. Scores range from 0 - 14 and higher scores indicate better short-term memory.

Changes in Trail Making Test Part A (from baseline to 18 weeks follow-up)

时间窗: Baseline; 12 weeks; 18 weeks

Trail Making Test Part A is a time-based examination that requires individuals to connect randomly arranged numbers following the correct sequence. The time limit for this test is up to 150 seconds, and shorter duration pertains to better processing speed.

Changes in Trail Making Test Part B (from baseline to 18 weeks follow-up)

时间窗: Baseline; 12 weeks; 18 weeks

Trail Making Test Part B is a time-based examination that requires individuals to connect randomly arranged numbers and letters following the correct and alternating sequence. The time limit for this test is up to 300 seconds, and shorter duration pertains to better executive function.

Changes in the MoCA-Memory Index score (from baseline to 18 weeks follow-up)

时间窗: Baseline; 12 weeks; 18 weeks

The Memory Index Score of the Montreal Cognitive Assessment (MoCA-MIS) ranges from 0-15, which is based on free delayed recall, category cued recall, and multiple choice cued recall. Higher scores indicate better delayed recall ability.

次要结局

  • Changes in quality of life using Perceived Well-Being Scale (from baseline to 18 weeks follow-up)(Baseline; 12 weeks; 18 weeks)
  • Changes in mood using Geriatric Depression Scale-Short Form (from baseline to 18 weeks follow-up)(Baseline; 12 weeks; 18 weeks)
  • Changes in functional mobility using Short Physical Performance Battery (from baseline to 18 weeks follow-up)(Baseline; 12 weeks; 18 weeks)
  • Changes in blood pressure (from baseline to 18 weeks follow-up)(Baseline; 12 weeks; 18 weeks)
  • Changes in body-mass index (from baseline to 18 weeks follow-up)(Baseline; 12 weeks; 18 weeks)
  • Changes in waist circumference (from baseline to 18 weeks follow-up)(Baseline; 12 weeks; 18 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Angela Leung

Associate Professor

The Hong Kong Polytechnic University

研究点 (1)

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