Intellectual DisabilityNCT05336487
Physical Activity, Sports and Health in Adults With Intellectual Disabilities
A study testing Physical activity in people with Intellectual Disability, run by University of Copenhagen at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of an intellectual disability
Who cannot join
- Participants under guardianship
- Unable to give informed consent to participate on their own
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Nutrition, Exercise and Health, University of Copenhagen
Copenhagen, Capital Region of Denmark, 2200
About this study
Official title: 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:
- 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?
- Conditions
- Intellectual Disability
- Being tested
- Physical activity
- Keywords
- Intellectual disability, Physical activity, Cardiovascular fitness, Bone health, Body composition
- Medical subject headings
- Intellectual Disability, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activityOther
2 hours of physical activity per day, 5 days per week, for the intervention period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in body weight
Body weight in kilograms
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start1 Aug 2019
- Primary completion30 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A physically active intervention group is compared to a physically inactive control group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Elsass Foundation
- Responsible party
- Principal investigator, Jacob Wienecke, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05336487
- Sponsor's protocol ID
- 2553227/4242
- Status last verified
- Nov 2022
- First submitted
- 31 Mar 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity, Sports, and Health in Adults With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT05336487
- Acronym / sponsor ID
- 2553227/4242
- Conditions
- Intellectual Disability
- Keywords
- Intellectual disability, Physical activity, Cardiovascular fitness, Bone health, Body composition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Elsass Foundation
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A physically active intervention group is compared to a physically inactive control group
| Arm | Type | Receives |
|---|---|---|
| Physical Activity group (PA-group) | Experimental | Other: Physical activityThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of an intellectual disability
Key exclusion criteria (2 listed)
- Participants under guardianship
- Unable to give informed consent to participate on their own
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity2 hours of physical activity per day, 5 days per week, for the intervention period | Other | Physical Activity group (PA-group) |
Primary outcome
Change in body weight
Time frame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Body weight in kilograms
Change in body fat mass
Time frame: 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 lean mass
Time frame: 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 fat free mass
Time frame: 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 cardiovascular fitness
Time frame: 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 areal bone mineral density of the whole body
Time frame: 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 T-scores of the whole body
Time frame: 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)
Time frame: 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 T-scores of the lumbar spine (L1-L4)
Time frame: 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 areal bone mineral density of the bilateral femur regions
Time frame: 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 T-scores of the bilateral femur regions
Time frame: 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.
Change in plasma bone turn-over marker (CTX)
Time frame: 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
Change in Plasma bone turn-over marker (P1NP)
Time frame: 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
Plasma bone turn-over marker (Osteocalcin)
Time frame: Measurement will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)
Osteocalcin, measured as μg/L
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity in people with Intellectual Disability, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in body weight (time frame: Measurements will be obtained at pre-intervention, (0 weeks), mid intervention (14 weeks) and post intervention (40 weeks)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.