Intellectual Disability Clinical Trial
Official title:
Physical Activity, Sports, and Health in Adults With Intellectual Disabilities
Verified date | November 2022 |
Source | University of Copenhagen |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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?
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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Nutrition, Exercise and Health, University of Copenhagen | Copenhagen | Capital Region Of Denmark |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | Elsass Foundation, Novo Nordisk A/S |
Denmark,
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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