Group Interval Fitness Program for Adolescents With Cognitive Impairments in the School Setting.

Cognitive Impairment Clinical Trial

Official title:

Group Interval Fitness Program for Adolescents With Cognitive Impairments in the School Setting.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06061900
• Other study ID #: 23-0605
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 23, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: November 2023
• Source: University of Colorado, Denver
• Contact: Holly Ingham, DPT
• Phone: 7202902569
• Email: holly.ingham[@]anschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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?

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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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Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• Group exercise program
Group fitness program

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

References & Publications (5)

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. — View 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. Re — View 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 — View 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. — View 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/ijerph1701 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 minutes
Secondary	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.	30 second intervals