跳至主要内容
临床试验/NCT05744011
NCT05744011招募中不适用

Effects of Tango on Older People With Dementia. Randomized Controlled Study.

University of Burgundy3 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
124
试验地点
3
主要终点
Change from Baseline physical abilities (balance, gait speed and lower limbs strength) at 1 and 3 months

研究概览

简要总结

Cognitive impairment (CI) is the leading cause of loss of autonomy and has a huge impact on physical performance and quality of life (QOL) in older people. Pharmacological treatments currently available have modest efficacy at best. Dance as both artistic and physical activity, combining emotions, social interaction, and sensory stimulation, therefore appears as a non-pharmacological intervention, which could contribute to the prevention of functional decline.

Among all the existing dances, tango occupies a special place because of the cultural and emotional resonance it carries, but also because of what it leads to motor mobilization (variations in the rhythm of walking, rotation of the belts, weight transfers...). These characteristics seem to make the tango an excellent tool for the rehabilitation of balance and gait, as well as for the prevention of the loss of autonomy in older adults with CI.

The objective of this study is to evaluate and compare the effectiveness of an intervention based on tango and classical physical activity.

详细描述

CI is a major cause of loss of independence in older people. Alterations in balance and gait are very often present, these worsen the overall condition of the patient and are a sign of poor prognosis. Consequently, the quality of life of the patient and his family is severely affected. The pharmacological treatments currently available aim to alleviate the symptoms. Current data support the modest efficacy of these treatments at best. Non-pharmacological interventions (NPI) are key tools for improving physical performance, functional abilities, cognitive, psychological and social functioning. The benefits of NPIs are observed daily in the field. To be better known, recognized and deployed more widely, it is essential to evaluate their effects and their implementation in a scientific way by following the criteria of evidence-based medicine. Dancing is widely appreciated by older people. "It is both an artistic and physical activity that combines emotions, social interaction, sensory stimulation, thus creating enriched environmental conditions for the elderly". Tango in particular has been used as a therapeutic instrument for a long time. Its regular practice has benefits in many aspects of health and can have a positive impact on cognitive abilities, as it requires sustained attention. Studies on tango as a therapy in Parkinson's disease have shown its effectiveness in improving psychomotor and cognitive signs and especially in the quality of life. Numerous studies have demonstrated the benefits that dance-based interventions can bring, far outweighing the risk of falls they represent. From a motor point of view, tango is a moderate-intensity exercise in which static and dynamic postural control is stimulated. This dance, based on walking, proves to be an excellent tool for rehabilitation, prevention of falls, as well as for the prevention of functional decline in older people with CI.

Objectives: The general goal of this project is to analyze the effects of tango on physical abilities, gait and quality of life of older people with C

Secondary objectives:

  • Evaluate the effectiveness of this type of program compared to traditional treatment.
  • Refine the characteristics of effective management, concerning the dose, frequency, and duration of intervention.
  • Analyze the effects of tango on the spatiotemporal parameters of walking.

General hypotheses: Various studies have highlighted the positive effects of tango face of different conditions, including Parkinson's disease. Based on these findings, the investigators hypothesize that tango interventions have a positive effect on physical abilities and quality of life in older adults with CI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Over 65 years old
  • MMSE < 21
  • agreed to participate
  • lived permanently in the nursing home
  • able to walk 10 meters without human assistance

排除标准

  • medical contraindications,
  • limited life expectancy
  • bedridden persons.

结局指标

主要结局

Change from Baseline physical abilities (balance, gait speed and lower limbs strength) at 1 and 3 months

时间窗: Before intervention/ after 1 month / after 3 months

Physical abilities will be measured with the Short Physical Performance Battery (SPPB). This test is composed of three evaluation criteria: balance, walking speed and sit to stand \[23\]. Specifically, during the balance test, the subject had to maintain each of three distinct positions for 10 seconds (feet together, semi-tandem and tandem). The failure of a step was the condition to start the second test, in which the subject walked 4 meters two consecutive times. The best score was retained. Finally, the time taken to complete the fastest 5 chair lifts without the help of the upper limbs was evaluated. At the end of the three tests, a score of a maximum of 12 points could be obtained.

Change from Baseline general physical performance at 1 and 3 months

时间窗: Before intervention/ after 1 month / after 3 months

The Timed Up \& Go test (TUG) is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances. The individual must stand up from a chair (which should not be leaned up against a wall), walk a distance of 3 meters, turn around, walk back to the chair and sit down - all performed at a comfortable and safe pace. One practice trial is permitted to allow the individual to familiarize him/herself with the task. Timing commences with the verbal instruction "go" and stops when the patient returns to seated position. The individual wears their regular footwear and is permitted to use their walking aid (cane/walker) with its use indicated on the data collection form. No physical assistance is given.

次要结局

  • Change from Baseline ability to perform activities of daily living (ADL) at 1 and 3 months(Before intervention/ after 1 month / after 3 months)
  • Change from Baseline questionnaire on Quality of Life (QoL) at 1 and 3 months(Before intervention/ after 1 month / after 3 months)
  • Change from Baseline neuropsychiatric symptoms at 1 and 3 months(Before intervention/ after 1 month / after 3 months)
  • Change from Baseline signs and symptoms of major depression at 1 and 3 months(Before intervention/ after 1 month / after 3 months)

研究者

发起方
University of Burgundy
申办方类型
Other
责任方
Principal Investigator
主要研究者

France Mourey

Professor

University of Burgundy

研究点 (3)

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