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The Effectiveness of Baduajin in People With Intellectual Disability

Primary Purpose

Disability, Intellectual

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Baduajin
Sponsored by
University of the Basque Country (UPV/EHU)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disability, Intellectual focused on measuring intellectual disability, sheltered work, ageing, function

Eligibility Criteria

40 Years - 66 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of the Basque Country

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

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

in this arm of participants will not receive any intervention

Outcomes

Primary Outcome Measures

Change of Functionality
Functionality assessed by the Short Physical Performance Battery.

Secondary Outcome Measures

Change of Strength
Strength of the upper extremity assessed by the handgrip strength measured by a Jamar dynamometer
Change of Body Balance
Postural control is assessed with an stabilometric platform at an acquisition frequency of 50 Hz during 40 seconds.
Anthopometry
Height and body mass will be measured. Body Mass Index will be calculated as weight divided by height (kg/m2)

Full Information

First Posted
July 25, 2021
Last Updated
November 22, 2021
Sponsor
University of the Basque Country (UPV/EHU)
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1. Study Identification

Unique Protocol Identification Number
NCT05107973
Brief Title
The Effectiveness of Baduajin in People With Intellectual Disability
Official Title
The Effectiveness of Baduajin in People With Intellectual Disability in Supported Employment: A Randomized Clinical Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 1, 2021 (Actual)
Primary Completion Date
June 15, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Basque Country (UPV/EHU)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disability, Intellectual
Keywords
intellectual disability, sheltered work, ageing, function

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Randomized Controlled Trail
Masking
Investigator
Masking Description
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.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
in this arm of participants will be receiving the Baduajin intervention.
Arm Title
control
Arm Type
No Intervention
Arm Description
in this arm of participants will not receive any intervention
Intervention Type
Other
Intervention Name(s)
Baduajin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Functionality
Description
Functionality assessed by the Short Physical Performance Battery.
Time Frame
Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).
Secondary Outcome Measure Information:
Title
Change of Strength
Description
Strength of the upper extremity assessed by the handgrip strength measured by a Jamar dynamometer
Time Frame
Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).
Title
Change of Body Balance
Description
Postural control is assessed with an stabilometric platform at an acquisition frequency of 50 Hz during 40 seconds.
Time Frame
Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).
Title
Anthopometry
Description
Height and body mass will be measured. Body Mass Index will be calculated as weight divided by height (kg/m2)
Time Frame
Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of the Basque Country
City
Leioa
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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The Effectiveness of Baduajin in People With Intellectual Disability

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