Physical Activity, Sports and Health in Adults With Intellectual Disabilities

Study Overview
=================
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: 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? Can lasting effects be measured three and six months after the intervention? Does the intervention improve the motor competences for the participants? How does defined groups of adult persons with Down syndrome and Cerebral Palsy learn and retain a new motor skill?

Official Title
-----------------
Physical Activity, Sports, and Health in Adults With Intellectual Disabilities

Conditions
-----------------
Intellectual Disability

Intervention / Treatment
-----------------
* Other: Physical activity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of an intellectual disability Exclusion Criteria: Participants under guardianship Unable to give informed consent to participate on their own

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A physically active intervention group is compared to a physically inactive control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Activity group (PA-group)<br>The intervention group. Participants with intellectual disabilities is recruited from a local daily activity center, where the participants participate in teacher-organized physical activity  2 hours/day, 5 days/week. | Other: Physical activity<br>* 2 hours of physical activity per day, 5 days per week, for the intervention period<br>|
| No Intervention: Control Group (CON-group)<br>The control group. The participants with intellectual disabilities is recruited from daily activity centers, which does not use physical activity in their daily work with the participants. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intellectual disability, Physical activity, Cardiovascular fitness, Bone health, Body composition