Cognitive ImpairmentNCT06061900
Group Interval Fitness Program for Adolescents With Cognitive Impairments in the School Setting.
A study testing Group exercise program in people with Cognitive Impairment, run by University of Colorado, Denver.
Trial summary
This study examines the outcomes of a group interval fitness program for secondary students with cognitive impairments in the school setting. It is well documented in the literature that individuals with cognitive impairments and medical conditions are at an increased risk for a sedentary lifestyle, obesity, and poor… Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Group exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 23 Oct 2024to 31 May 2025
- 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 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Must be enrolled in a secondary school within the Aurora Public Schools district and attend a physical education class.
- Cognitive IQ less than 70 on a standardized measure documented in an Individualized Education Plan or Evaluation.
- Ambulatory without an assistive device.
- Not receiving intensive Physical Therapy services during the study or prior six months.
- Able to follow verbal instructions for completing exercises, physical activities, and outcome measures.
- At the time of the study, the participant does not have any acute orthopedic injuries that would impact active participation in physical education.
- -
Who cannot join
- Student is unable to follow verbal instructions for completing exercise, physical activities, and outcome measures.
- Student is 18 years old.
- Student used a wheelchair or assistive device for primary mobility.
- -
Trial locations and contacts
No sites are listed yet.
About this study
This study examines the outcomes of a group interval fitness program for secondary students with cognitive impairments in the school setting. It is well documented in the literature that individuals with cognitive impairments and medical conditions are at an increased risk for a sedentary lifestyle, obesity, and poor health-related fitness. These factors may further contribute to difficulties with planning for transitions from high school to young adulthood, independent or supported employment, and functional activities of daily living. An eight-week resistive exercise program was designed for secondary students with significant cognitive impairments who are participating in physical education classes as part of their standard curriculum. The goal of this study is to compare the outcomes related to strength, mobility, and functional activities for students in the intervention group compared to students who do not participate in this group interval program. This study investigates several important questions. Is a group fitness program effective in a school-based setting? Do individuals with cognitive impairments benefit from a group fitness program? Can a group fitness program correlate to functional and/or participation changes? With a group fitness program can changes be seen in lower extremity strength, upper extremity strength, grip strength, and mobility? How does a structured exercise group compare to a physical education class? Do physical education classes provide enough intensity for students with cognitive impairments?
Read the detailed description
This prospective cohort study will compare students who received an exercise intervention group to those who did not. The cohorts share some things in common such as IQ, ambulatory status, and attending a physical education class.
Intervention will include a warm-up, restive exercises with dumbbells, interval training, game or dancing, and cool down. Intervention sessions will run for 30-45 minutes, 2-3 times a week, for 8 weeks.
Warm-up - 2-5 minutes
Dumbbells - 10-15 minutes
Interval training - 10-15 minutes
Game/Dance/Cool Down - 10 minutes
Pre and post-testing will be completed by a trained physical therapist, occupational therapist, or student of physical therapy who is completing a supervised clinical internship under a licensed physical therapist. Prior to any testing, the PI will conduct training sessions to ensure consistency between all testers. Pre and post-testing will be completed by a different group of physical therapists, occupational therapists, or students of physical therapy than the individuals providing the intervention. Individuals leading the intervention sessions will attend training sessions on the protocol and could be a physical therapist, occupational therapist, student physical therapist, adapted physical education teacher, or teacher.
High school and middle school buildings will be assigned into two groups: control and intervention, with the goal to have 5-6 buildings in each group. Participants in the control buildings will participate in pre and post-testing at the start and end of the eight-week program. During the eight weeks, participants in control buildings will continue with their normally scheduled physical education classes. Participants in the intervention buildings will also complete pre and post-testing and attend the fitness program during the eight weeks. Participants in the intervention buildings will attend their regularly scheduled physical education classes 2-3 times a week and the intervention group fitness program the other 2-3 days.
- Conditions
- Cognitive Impairment
- Being tested
- Group exercise program
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group exercise programOther
Group fitness program
| Study group | Role | What they receive |
|---|---|---|
| Participants who receive group exercise intervention | Experimental | Intervention will include a warm-up, restive exercises with dumbbells, interval training, game or dancing, and cool down. Intervention sessions will run for 30-45 minutes, 2-3 times a week, for 8 weeks. Participants will also participate in pre and post-testing. Receives: Other: Group exercise program |
| Participants who do not receive group exercise intervention | No intervention | Participants will participate in pre and post-testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 Minute Walk Test
The 6MWT measures the distance an individual can walk in six minutes on a level, flat surface. Individuals are asked to walk as fast as possible without running or being unsafe. This test is a submaximal exercise test used to measure function and endurance.
Measured: 6 minutes
Secondary outcomes (1)
Functional Strength Tests
FST is comprised of three individual subtests including 30 seconds sit to stand, 30 seconds lateral step ups, and 30 seconds half-kneel to stand. Both half-kneel to stand and lateral step ups are completed on each leg. The individual is asked to complete as many repetitions as possible within the 30 second time frame. These tests measure lower extremity strength in a functional manner.
Measured: 30 second intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start23 Oct 2024 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Holly L Ingham, DPT, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06061900
- Sponsor's protocol ID
- 23-0605
- Status last verified
- Nov 2023
- First submitted
- 25 Sep 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wouters M, Evenhuis HM, Hilgenkamp TIM. Physical fitness of children and adolescents with moderate to severe intellectual disabilities. Disabil Rehabil. 2020 Sep;42(18):2542-2552. doi: 10.1080/09638288.2019.1573932. Epub 2019 Apr 11.
PubMed 30973765Wang A, Gao Y, Wang J, Brown TJ, Sun Y, Yu S, Tong TK, Zhong LLD, Fong SSM, Dutheil F, Baker JS. Interventions for health-related physical fitness and overweight and obesity in children with intellectual disability: Systematic review and meta-analysis. J Appl Res Intellect Disabil. 2022 Sep;35(5):1073-1087. doi: 10.1111/jar.12999. Epub 2022 Apr 20.
PubMed 35445495Oppewal A, Hilgenkamp TI, van Wijck R, Schoufour JD, Evenhuis HM. Physical fitness is predictive for a decline in the ability to perform instrumental activities of daily living in older adults with intellectual disabilities: Results of the HA-ID study. Res Dev Disabil. 2015 Jun-Jul;41-42:76-85. doi: 10.1016/j.ridd.2015.05.002. Epub 2015 Jun 14.
PubMed 26079525Yuksel HS, Sahin FN, Maksimovic N, Drid P, Bianco A. School-Based Intervention Programs for Preventing Obesity and Promoting Physical Activity and Fitness: A Systematic Review. Int J Environ Res Public Health. 2020 Jan 3;17(1):347. doi: 10.3390/ijerph17010347.
PubMed 31947891Collins K, Staples K. The role of physical activity in improving physical fitness in children with intellectual and developmental disabilities. Res Dev Disabil. 2017 Oct;69:49-60. doi: 10.1016/j.ridd.2017.07.020.
PubMed 28818714
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Interval Fitness Program for Adolescents With Cognitive Impairments in the School Setting.
- ClinicalTrials.gov ID
- NCT06061900
- Acronym / sponsor ID
- 23-0605
- Conditions
- Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 23 Oct 2024 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 29 Sep 2023 (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.
This study examines the outcomes of a group interval fitness program for secondary students with cognitive impairments in the school setting. It is well documented in the literature that individuals with cognitive impairments and medical conditions are at an increased risk for a sedentary lifestyle, obesity, and poor health-related fitness. These factors may further contribute to difficulties with planning for transitions from high school to young adulthood, independent or supported employment, and functional activities of daily living. An eight-week resistive exercise program was designed for secondary students with significant cognitive impairments who are participating in physical education classes as part of their standard curriculum. The goal of this study is to compare the outcomes related to strength, mobility, and functional activities for students in the intervention group compared to students who do not participate in this group interval program. This study investigates several important questions. Is a group fitness program effective in a school-based setting? Do individuals with cognitive impairments benefit from a group fitness program? Can a group fitness program correlate to functional and/or participation changes? With a group fitness program can changes be seen in lower extremity strength, upper extremity strength, grip strength, and mobility? How does a structured exercise group compare to a physical education class? Do physical education classes provide enough intensity for students with cognitive impairments?
Detailed description
This prospective cohort study will compare students who received an exercise intervention group to those who did not. The cohorts share some things in common such as IQ, ambulatory status, and attending a physical education class.
Intervention will include a warm-up, restive exercises with dumbbells, interval training, game or dancing, and cool down. Intervention sessions will run for 30-45 minutes, 2-3 times a week, for 8 weeks.
Warm-up - 2-5 minutes
Dumbbells - 10-15 minutes
Interval training - 10-15 minutes
Game/Dance/Cool Down - 10 minutes
Pre and post-testing will be completed by a trained physical therapist, occupational therapist, or student of physical therapy who is completing a supervised clinical internship under a licensed physical therapist. Prior to any testing, the PI will conduct training sessions to ensure consistency between all testers. Pre and post-testing will be completed by a different group of physical therapists, occupational therapists, or students of physical therapy than the individuals providing the intervention. Individuals leading the intervention sessions will attend training sessions on the protocol and could be a physical therapist, occupational therapist, student physical therapist, adapted physical education teacher, or teacher.
High school and middle school buildings will be assigned into two groups: control and intervention, with the goal to have 5-6 buildings in each group. Participants in the control buildings will participate in pre and post-testing at the start and end of the eight-week program. During the eight weeks, participants in control buildings will continue with their normally scheduled physical education classes. Participants in the intervention buildings will also complete pre and post-testing and attend the fitness program during the eight weeks. Participants in the intervention buildings will attend their regularly scheduled physical education classes 2-3 times a week and the intervention group fitness program the other 2-3 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants who receive group exercise intervention | Experimental | Other: Group exercise programIntervention will include a warm-up, restive exercises with dumbbells, interval training, game or dancing, and cool down. Intervention sessions will run for 30-45 minutes, 2-3 times a week, for 8 weeks. Participants will also participate in pre and post-testing. |
| Participants who do not receive group exercise intervention | No intervention | –Participants will participate in pre and post-testing. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Must be enrolled in a secondary school within the Aurora Public Schools district and attend a physical education class.
- Cognitive IQ less than 70 on a standardized measure documented in an Individualized Education Plan or Evaluation.
- Ambulatory without an assistive device.
- Not receiving intensive Physical Therapy services during the study or prior six months.
- Able to follow verbal instructions for completing exercises, physical activities, and outcome measures.
Key exclusion criteria (4 listed)
- Student is unable to follow verbal instructions for completing exercise, physical activities, and outcome measures.
- Student is 18 years old.
- Student used a wheelchair or assistive device for primary mobility.
- -
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 |
|---|---|---|
| Group exercise programGroup fitness program | Other | Participants who receive group exercise intervention |
Primary outcome
6 Minute Walk Test
Time frame: 6 minutes
The 6MWT measures the distance an individual can walk in six minutes on a level, flat surface. Individuals are asked to walk as fast as possible without running or being unsafe. This test is a submaximal exercise test used to measure function and endurance.
1 secondary outcome
Functional Strength Tests
Time frame: 30 second intervals
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Results publication: PubMed 30973765Wouters M, Evenhuis HM, Hilgenkamp TIM. Physical fitness of children and adolescents with moderate to severe intellectual disabilities. Disabil Rehabil. 2020 Sep;42(18):2542-2552. doi: 10.1080/09638288.2019.1573932. Epub 2019 Apr 11.
- Results publication: PubMed 35445495Wang A, Gao Y, Wang J, Brown TJ, Sun Y, Yu S, Tong TK, Zhong LLD, Fong SSM, Dutheil F, Baker JS. Interventions for health-related physical fitness and overweight and obesity in children with intellectual disability: Systematic review and meta-analysis. J Appl Res Intellect Disabil. 2022 Sep;35(5):1073-1087. doi: 10.1111/jar.12999. Epub 2022 Apr 20.
- Results publication: PubMed 26079525Oppewal A, Hilgenkamp TI, van Wijck R, Schoufour JD, Evenhuis HM. Physical fitness is predictive for a decline in the ability to perform instrumental activities of daily living in older adults with intellectual disabilities: Results of the HA-ID study. Res Dev Disabil. 2015 Jun-Jul;41-42:76-85. doi: 10.1016/j.ridd.2015.05.002. Epub 2015 Jun 14.
- Results publication: PubMed 31947891Yuksel HS, Sahin FN, Maksimovic N, Drid P, Bianco A. School-Based Intervention Programs for Preventing Obesity and Promoting Physical Activity and Fitness: A Systematic Review. Int J Environ Res Public Health. 2020 Jan 3;17(1):347. doi: 10.3390/ijerph17010347.
- Results publication: PubMed 28818714Collins K, Staples K. The role of physical activity in improving physical fitness in children with intellectual and developmental disabilities. Res Dev Disabil. 2017 Oct;69:49-60. doi: 10.1016/j.ridd.2017.07.020.
- 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.
Holly L Ingham, DPT principal investigator
University of Colorado, Denver
Questions about this trial
What is this clinical trial studying?
A study testing Group exercise program in people with Cognitive Impairment, run by University of Colorado, Denver.
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 7 inclusion and 4 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 30 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Holly Ingham, DPT (7202902569, holly.ingham@anschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 Minute Walk Test (time frame: 6 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06061900, which also lists 5 linked publications.
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 30 Nov 2023.