Physical Activity, Sports and Health in Adults With Intellectual Disabilities

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Intellectual Disability
• Intervention / Treatment: Other: Physical activity

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region Of Denmark
    • Copenhagen, Capital Region Of Denmark, Denmark, 2200
      • Department of Nutrition, Exercise and Health, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of an intellectual disability

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical Activity group (PA-group); 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; 2 hours of physical activity per day, 5 days per week, for the intervention period
No Intervention: Control Group (CON-group); 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)

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Novo Nordisk A/S; Elsass Foundation

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Anticipated): December 30, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: March 31, 2022
• First Submitted That Met QC Criteria: April 19, 2022
• First Posted (Actual): April 20, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Physical activity; Body composition; Bone health; Intellectual disability; Cardiovascular fitness
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: 2553227/4242

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No