Physical Activity, Sports and Health in Adults With Intellectual Disabilities

Intellectual Disability Clinical Trial

Official title:

Physical Activity, Sports, and Health in Adults With Intellectual Disabilities

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05336487
• Other study ID #: 2553227/4242
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Currently, there is a paucity of quality research within the field of health science with a focus on persons with intellectual disabilities, and especially how longer lasting periods of varied physical activity affects the target group. There is a lack of insight, in how persons with intellectual disabilities learns and retains movement skills. Thus, the research group behind this project will investigate the following research questions:

1. Does 40 weeks of intense and varied sports and physical activities as an intervention lead to positive changes in health status for adults with intellectual disabilities?

2. Can lasting effects be measured three and six months after the intervention?

3. Does the intervention improve the motor competences for the participants?

4. How does defined groups of adult persons with Down syndrome and Cerebral Palsy learn and retain a new motor skill?

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 85
• Est. completion date: December 31, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of an intellectual disability

Exclusion Criteria:

• Participants under guardianship

• Unable to give informed consent to participate on their own

Related Conditions & MeSH terms

• Intellectual Disability

Intervention

Other:
• Physical activity
2 hours of physical activity per day, 5 days per week, for the intervention period

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Health, University of Copenhagen	Copenhagen	Capital Region Of Denmark

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Elsass Foundation, Novo Nordisk A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Body weight in kilograms	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in body fat mass	Body fat mass in kilograms	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in lean mass	Lean body mass in kilograms	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in fat free mass	Fat free mass in kilograms	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in cardiovascular fitness	Change in heart rate during the same absolute submaximal exercise intensity	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in areal bone mineral density of the whole body	Areal bone mineral density in grams per square centimeter (g/cm2) of the whole body	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in T-scores of the whole body	Whole body T-score. An arbitrary measure, describing the bone mineral density of the subjects relative to a reference value from 30 year old healthy persons.	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in areal bone mineral density of the lumbar spine (L1-L4)	Areal bone mineral density in grams per square centimeter (g/cm2) of the lumbar spine (L1-L4)	Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in T-scores of the lumbar spine (L1-L4)	Lumbar spine (L1-L4) T-score. An arbitrary measure, describing the bone mineral density of the subjects relative to a reference value from 30 year old healthy persons.	Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in areal bone mineral density of the bilateral femur regions	Areal bone mineral density grams per square centimeter (g/cm2) of the bilateral femur regions	Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in T-scores of the bilateral femur regions	T-scores of the bilateral femur regions. An arbitrary measure, describing the bone mineral density of the subjects relative to a reference value from 30 year old healthy persons.	Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in plasma bone turn-over marker (CTX)	Carboxy-terminal collagen crosslinks (CTX), measured as µg/L	Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Change in Plasma bone turn-over marker (P1NP)	Procollagen type 1 N-terminal propeptide (P1NP), measured as µg/L	Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Primary	Plasma bone turn-over marker (Osteocalcin)	Osteocalcin, measured as µg/L	Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

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