Clinical trial NCT06061900: Group Interval Fitness Program for Adolescents With Cognitive Impairments in the School Setting.
Official title: Group Interval Fitness Program for Adolescents With Cognitive Impairments in the School Setting.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2023-09-29
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

1. Must be enrolled in a secondary school within the Aurora Public Schools district and attend a physical education class.
2. Cognitive IQ less than 70 on a standardized measure documented in an Individualized Education Plan or Evaluation.
3. Ambulatory without an assistive device.
4. Not receiving intensive Physical Therapy services during the study or prior six months.
5. Able to follow verbal instructions for completing exercises, physical activities, and outcome measures.
6. At the time of the study, the participant does not have any acute orthopedic injuries that would impact active participation in physical education.

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Exclusion Criteria:

1. Student is unable to follow verbal instructions for completing exercise, physical activities, and outcome measures.
2. Student is 18 years old.
3. Student used a wheelchair or assistive device for primary mobility.

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Primary outcomes:
measure: 6 Minute Walk Test
timeFrame: 6 minutes
Secondary outcomes:
measure: Functional Strength Tests
timeFrame: 30 second intervals
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Holly L Ingham, DPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Wang 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.
citation: Oppewal 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.
citation: Yuksel 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.
citation: Collins 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.