Clinical trial NCT05336487: Physical Activity, Sports and Health in Adults With Intellectual Disabilities
Official title: Physical Activity, Sports, and Health in Adults With Intellectual Disabilities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intellectual Disability
Keywords: Intellectual disability
Physical activity
Cardiovascular fitness
Bone health
Body composition
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: Elsass Foundation
First posted: 2022-04-20
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A physically active intervention group is compared to a physically inactive control group
Primary purpose: TREATMENT

Brief 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?


Eligibility criteria: Inclusion Criteria:

* Presence of an intellectual disability

Exclusion Criteria:

* Participants under guardianship
* Unable to give informed consent to participate on their own

Primary outcomes:
measure: Change in body weight
timeFrame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in body fat mass
timeFrame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in lean mass
timeFrame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in fat free mass
timeFrame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in cardiovascular fitness
timeFrame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in areal bone mineral density of the whole body
timeFrame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in T-scores of the whole body
timeFrame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in areal bone mineral density of the lumbar spine (L1-L4)
timeFrame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in T-scores of the lumbar spine (L1-L4)
timeFrame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in areal bone mineral density of the bilateral femur regions
timeFrame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in T-scores of the bilateral femur regions
timeFrame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in plasma bone turn-over marker (CTX)
timeFrame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Change in Plasma bone turn-over marker (P1NP)
timeFrame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
measure: Plasma bone turn-over marker (Osteocalcin)
timeFrame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Health, University of Copenhagen
state: Capital Region Of Denmark
Study officials:
References: