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Physical Activity, Sports and Health in Adults With Intellectual Disabilities

Primary Purpose

Intellectual Disability

Status

Active

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Physical activity

About this trial

This is an interventional treatment trial for Intellectual Disability focused on measuring Intellectual disability, Physical activity, Cardiovascular fitness, Bone health, Body composition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Presence of an intellectual disability

Exclusion Criteria:

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

Sites / Locations

Department of Nutrition, Exercise and Health, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Physical Activity group (PA-group)

Control Group (CON-group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in body weight

Body weight in kilograms

Change in body fat mass

Body fat mass in kilograms

Change in lean mass

Lean body mass in kilograms

Change in fat free mass

Fat free mass in kilograms

Change in cardiovascular fitness

Change in heart rate during the same absolute submaximal exercise intensity

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

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.

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)

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.

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

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.

Change in plasma bone turn-over marker (CTX)

Carboxy-terminal collagen crosslinks (CTX), measured as μg/L

Change in Plasma bone turn-over marker (P1NP)

Procollagen type 1 N-terminal propeptide (P1NP), measured as μg/L

Plasma bone turn-over marker (Osteocalcin)

Osteocalcin, measured as μg/L

Secondary Outcome Measures

Full Information

NCT ID

NCT05336487

First Posted

March 31, 2022

Last Updated

November 7, 2022

Sponsor

University of Copenhagen

Collaborators

Novo Nordisk A/S, Elsass Foundation

1. Study Identification

Unique Protocol Identification Number

NCT05336487

Brief Title

Physical Activity, Sports and Health in Adults With Intellectual Disabilities

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

August 1, 2019 (Actual)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Copenhagen

Collaborators

Novo Nordisk A/S, Elsass Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Intellectual Disability

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

85 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Physical Activity group (PA-group)

Arm Type

Experimental

Arm Description

Arm Title

Control Group (CON-group)

Arm Type

No Intervention

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

Physical activity

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in body weight

Description

Body weight in kilograms

Time Frame

Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

Title

Change in body fat mass

Description

Body fat mass in kilograms

Time Frame

Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

Title

Change in lean mass

Description

Lean body mass in kilograms

Time Frame

Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

Title

Change in fat free mass

Description

Fat free mass in kilograms

Time Frame

Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

Title

Change in cardiovascular fitness

Description

Change in heart rate during the same absolute submaximal exercise intensity

Time Frame

Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

Title

Change in areal bone mineral density of the whole body

Description

Areal bone mineral density in grams per square centimeter (g/cm2) of the whole body

Time Frame

Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

Title

Change in T-scores of the whole body

Description

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.

Time Frame

Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)

Title

Change in areal bone mineral density of the lumbar spine (L1-L4)

Description

Areal bone mineral density in grams per square centimeter (g/cm2) of the lumbar spine (L1-L4)

Time Frame