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临床试验/NCT05107973
NCT05107973Unknown不适用

The Effectiveness of Baduajin in People With Intellectual Disability in Supported Employment: A Randomized Clinical Controlled Trial

University of the Basque Country (UPV/EHU)1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Change of Functionality

研究概览

简要总结

Due to the ageing process, individuals with intellectual disability (ID) experience decreased balance and loss of functionality at an earlier age than their peers without ID. Above-mentioned negative effects of the age affect particularly work ability, forcing to the retirement. It also implies difficulties for social interaction and economic problems, among others.

Baduajin is a traditional Chinese exercise and it has been demonstrated as an effective therapy in different alterations of the movement (i.e. Parkinson Disease).

The hypothesis of this study is that a training program of Badaujing will improve the balance and functionality of individuals with ID over 40 years old that from a company of in sheltered work.

Subjects with mild to moderate ID aged 40 years or older who are working in Lantegi Batuak (Bizkaia, Spain) will be invited to take part in an Baduajin intervention. The training program will consist in a 1 hour session each week during 9 month. Participants will be randomly assigned to a control or intervention group. Before and after the intervention, all the participants will be assessed with the following protocol: SPPB for functionality, balance in stabilometric platform, and strength of the upper limb.

详细描述

Intellectual disability (ID) is defined as a significantly reduced ability to understand new or complex information and to learn and apply new skills (impaired intelligence). This results in a reduced ability to cope independently (impaired social functioning), and begins before adulthood, with a lasting effect on development. For the first time in history, adults with intellectual and developmental disabilities are living to experience old age. Although the impact of ID on life expectancy is variable, most people with mild-to-moderate mental impairment can now expect to live as long as their non-disabled peers. Nevertheless, the ageing process and related functional problems seem to have an earlier onset in people with ID, charasterized by impairtment of movement and balance skills, which could lead to an increased risk of falls, and in turn, to a higher risk of disability and loss of quality of life.

The social and health-related benefits of the integration of the people with ID in the workplace are well known. People with ID often want to participate in work and organisation. However, these persons are much less likely to be employed than their non-disabled peers. In addition, people with ID who are in employment tend to need to retire earlier, producing social, economic and health problems.

On one hand, Lantegi Batuak is a provider of supported employment for more than 1000 people with ID in Bizkaia (Spain). At the above-mentioend company it was found that workers with ID over 40 years old showed problems related to ageing, which include loss of body balance and in consequence less functionality. In consequence, methodologies for the prevention of the problems related to the ageing process in people with ID are particularlly interesting for the above-mentioned comapany, and can be potentially interesting for other public and private providers of supported employment. On the other hand, as has been previously demonstrated, Baduajing can enhance the body balance and functionality in different conditions. However, it have found no evidence concerning the use of this method for improving the function of people with ID.

The aim of this research is to ascertain the efficacy of a Baduanjing program for improving the body balance and functionality of people with ID, aged 40 or older, who are working in Lantegi Batuak. A total of 40 participants will be randomly allocated to a control or intervention group. The intervention will consist in a 1 hour supervised Baduajin group sessions conducted once a week during 9 month. The effect of the intervention and the lack of this will be assessed. For this, a full test-protocol including anthropometry, functionality and body balance, will be perform inmediatly before and after the intervention, as well as after 3 month of the intervention.

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
Single (Investigator)

盲法说明

Randomization will be done by the person responsible for the project in the company. Nobody from the research team will know in which arm are enroled the participants.

入排标准

年龄范围
40 Years 至 66 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Workers of Lantegi Batuak (Basque Country, Spain),
  • •Age: between 40 and 66 years old
  • •Diagnostic: mild to moderate ID or down syndrome, or Steinert disease
  • •Enough ability to participate in activities in groups of 10 people.

排除标准

  • •Previous experience in Baduajin
  • •Lack of capactiy to participate in groups.

研究组 & 干预措施

intervention

Experimental

in this arm of participants will be receiving the Baduajin intervention.

干预措施: Baduajin (Other)

control

No Intervention

in this arm of participants will not receive any intervention

结局指标

主要结局

Change of Functionality

时间窗: Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).

Functionality assessed by the Short Physical Performance Battery.

次要结局

  • Change of Body Balance(Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).)
  • Anthopometry(Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).)
  • Change of Strength(Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).)

研究者

发起方
University of the Basque Country (UPV/EHU)
申办方类型
Other
责任方
Principal Investigator
主要研究者

JON TORRES UNDA

Dr, Lecturer

University of the Basque Country (UPV/EHU)

研究点 (1)

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