NCT05107973

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 4, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

10 months

First QC Date

July 25, 2021

Last Update Submit

November 22, 2021

Conditions

Keywords

intellectual disabilitysheltered workageingfunction

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

EXPERIMENTAL

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

Other: Baduajin

control

NO INTERVENTION

in 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.

intervention

Eligibility Criteria

Age40 Years - 66 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

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
Model Details: Parallel Randomized Controlled Trail
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

Locations