The Effectiveness of Baduajin in People With Intellectual Disability

NCT ID: NCT05107973

Last Updated: 2021-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Disability, Intellectual

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

intellectual disability sheltered work ageing function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Randomized Controlled Trail
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

intervention

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

Group Type EXPERIMENTAL

Baduajin

Intervention Type OTHER

The intervention will consist in a 1 hour supervised Baduajin sessions conducted once a week a certified instructor with more than 10 years of experience. Each session will start with 5 min of warm up, 50 minutes of Baduajin and 5 min of cool down. In the main part the participants exercise the wholes set of Baduajin that consist of eigth forms.

control

in this arm of participants will not receive any intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Baduajin

The intervention will consist in a 1 hour supervised Baduajin sessions conducted once a week a certified instructor with more than 10 years of experience. Each session will start with 5 min of warm up, 50 minutes of Baduajin and 5 min of cool down. In the main part the participants exercise the wholes set of Baduajin that consist of eigth forms.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* Previous experience in Baduajin
* Lack of capactiy to participate in groups.
Minimum Eligible Age

40 Years

Maximum Eligible Age

66 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of the Basque Country (UPV/EHU)

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

JON TORRES UNDA

Dr, Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of the Basque Country

Leioa, Bizkaia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TORRES-UNDA 2021 BADUAJIN ID

Identifier Type: -

Identifier Source: org_study_id