Physical Activity, Sports and Health in Adults With Intellectual Disabilities

NCT05336487 | Unknown

• 1 other identifier: 2553227/4242
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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. 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. 2.Can lasting effects be measured three and six months after the intervention?
3. 3.Does the intervention improve the motor competences for the participants?
4. 4.How does defined groups of adult persons with Down syndrome and Cerebral Palsy learn and retain a new motor skill?

Conditions

Intellectual Disability

Keywords

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

Outcome Measures

Primary Outcomes (14)

• 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)

Study Arms (2)

Physical Activity group (PA-group)

EXPERIMENTAL

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

Control Group (CON-group)

NO INTERVENTION

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.

Interventions

Physical activity OTHER

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

Physical Activity group (PA-group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of an intellectual disability

You may not qualify if:

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

Sponsors & Collaborators

• University of Copenhagen: lead
• Novo Nordisk A/S: collaborator
• Elsass Foundation: collaborator

Study Sites (1)

Department of Nutrition, Exercise and Health, University of Copenhagen

Copenhagen, Capital Region of Denmark, 2200, Denmark

Location

Related Links

• Related Info

MeSH Terms

Conditions

Intellectual Disability; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Associate Professor

Model Details: A physically active intervention group is compared to a physically inactive control group

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 20, 2022
• Study Start: August 1, 2019
• Primary Completion: December 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)