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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05336487
Other study ID # 2553227/4242
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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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