Physical Activity, Sports and Health in Adults With Intellectual Disabilities

Not Applicable

Active, not recruiting

• Conditions: Intellectual Disability
• Interventions: Other: Physical activity

• Registration Number: NCT05336487
• Lead Sponsor: University of Copenhagen

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?

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-01
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-19
• Study First Posted: 2022-04-20
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-07
• Last Update Posted: 2022-11-08
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

• Presence of an intellectual disability

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical Activity group (PA-group)	Physical activity	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.

Primary Outcome Measures

Name	Time	Method
Change in body fat mass	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)	Body fat mass in kilograms
Change in cardiovascular fitness	Measurements 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 T-scores of the whole body	Measurements 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 fat free mass	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)	Fat free mass in kilograms
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 lean mass	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)	Lean body mass in kilograms
Change in areal bone mineral density of the whole body	Measurements 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 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
Change in body weight	Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)	Body weight in kilograms
Change in areal bone mineral density of the bilateral femur regions	Measurement 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 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
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
Change in T-scores of the bilateral femur regions	Measurement 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.

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Health, University of Copenhagen; 🇩🇰 Copenhagen, Capital Region Of Denmark, Denmark