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Physical Activity, Sports and Health in Adults With Intellectual Disabilities

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05336487
Enrollment
85
Registered
2022-04-20
Start date
2019-08-01
Completion date
2022-12-31
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intellectual Disability

Keywords

Intellectual disability, Physical activity, Cardiovascular fitness, Bone health, Body composition

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?

Interventions

OTHERPhysical activity

2 hours of physical activity per day, 5 days per week, for the intervention period

Sponsors

Novo Nordisk A/S
CollaboratorINDUSTRY
Elsass Foundation
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

A physically active intervention group is compared to a physically inactive control group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Presence of an intellectual disability

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Change in body weightMeasurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Body weight in kilograms
Change in body fat massMeasurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Body fat mass in kilograms
Change in lean massMeasurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Lean body mass in kilograms
Change in fat free massMeasurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Fat free mass in kilograms
Change in cardiovascular fitnessMeasurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Change in heart rate during the same absolute submaximal exercise intensity
Change in areal bone mineral density of the whole bodyMeasurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Areal bone mineral density in grams per square centimeter (g/cm2) of the whole body
Change in T-scores of the whole bodyMeasurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)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.
Change in areal bone mineral density of the lumbar spine (L1-L4)Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Areal bone mineral density in grams per square centimeter (g/cm2) of the lumbar spine (L1-L4)
Change in T-scores of the lumbar spine (L1-L4)Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)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.
Change in areal bone mineral density of the bilateral femur regionsMeasurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Areal bone mineral density grams per square centimeter (g/cm2) of the bilateral femur regions
Change in T-scores of the bilateral femur regionsMeasurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)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.
Change in plasma bone turn-over marker (CTX)Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Carboxy-terminal collagen crosslinks (CTX), measured as μg/L
Change in Plasma bone turn-over marker (P1NP)Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Procollagen type 1 N-terminal propeptide (P1NP), measured as μg/L
Plasma bone turn-over marker (Osteocalcin)Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)Osteocalcin, measured as μg/L

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026