Physical Activity, Sports and Health in Adults With Intellectual Disabilities

• Sponsor: University of Copenhagen (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05336487
• Collaborator: Novo Nordisk A/S (Industry), Elsass Foundation (Other)
• Enrollment: 85
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Intellectual Disability	Other: Physical activity	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 85 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A physically active intervention group is compared to a physically inactive control groupA physically active intervention group is compared to a physically inactive control group
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Physical Activity, Sports, and Health in Adults With Intellectual Disabilities
• Actual Study Start Date: Aug 1, 2019
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Dec 31, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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.

8. 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)

9. 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.

10. 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

11. 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.

12. 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

13. 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

14. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Nutrition, Exercise and Health, University of Copenhagen	Copenhagen	Capital Region Of Denmark	Denmark	2200

Sponsors and Collaborators

• University of Copenhagen
• Novo Nordisk A/S
• Elsass Foundation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Jacob Wienecke, Principal Investigator, Associate Professor, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT05336487
• Other Study ID Numbers: 2553227/4242
• First Posted: Apr 20, 2022
• Last Update Posted: Apr 20, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jacob Wienecke, Principal Investigator, Associate Professor, University of Copenhagen: Intellectual disability; Physical activity; Cardiovascular fitness; Bone health; Body composition
• Additional relevant MeSH terms: Intellectual Disability

Study Results

No Results Posted as of Apr 20, 2022