The Effectiveness of Baduajin in People With Intellectual Disability

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Disability, Intellectual
• Intervention / Treatment: Other: Baduajin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Leioa, Bizkaia, Spain, 48903
      • University of the Basque Country

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention; in this arm of participants will be receiving the Baduajin intervention.	Other: 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.
No Intervention: control; in this arm of participants will not receive any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Functionality	Functionality assessed by the Short Physical Performance Battery.	Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Strength	Strength of the upper extremity assessed by the handgrip strength measured by a Jamar dynamometer	Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).
Change of Body Balance	Postural control is assessed with an stabilometric platform at an acquisition frequency of 50 Hz during 40 seconds.	Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).
Anthopometry	Height and body mass will be measured. Body Mass Index will be calculated as weight divided by height (kg/m2)	Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).

Collaborators and Investigators

• Sponsor: University of the Basque Country (UPV/EHU)

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2021
• Primary Completion (Anticipated): June 15, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: October 23, 2021
• First Posted (Actual): November 4, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: function; ageing; intellectual disability; sheltered work
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: TORRES-UNDA 2021 BADUAJIN ID

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No