The Effectiveness of Baduajin in People With Intellectual Disability
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2021
CompletedStudy Start
First participant enrolled
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
November 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedDecember 3, 2021
November 1, 2021
10 months
July 25, 2021
November 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change of Strength
Baseline (week 0), post-intervention (week 28) and 3 month after the intervention (week 40).
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).
Study Arms (2)
intervention
EXPERIMENTALin this arm of participants will be receiving the Baduajin intervention.
control
NO INTERVENTIONin this arm of participants will not receive any intervention
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Previous experience in Baduajin
- Lack of capactiy to participate in groups.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of the Basque Country
Leioa, Bizkaia, 48903, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Masking Details
- 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.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr, Lecturer
Study Record Dates
First Submitted
July 25, 2021
First Posted
November 4, 2021
Study Start
September 1, 2021
Primary Completion
June 15, 2022
Study Completion
September 1, 2022
Last Updated
December 3, 2021
Record last verified: 2021-11