NCT06061900

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?

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 25, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 29, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 23, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
Last Updated

November 30, 2023

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

September 25, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Functional Strength Tests

    30 second intervals

Study Arms (2)

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.

Other: Group exercise program

Participants who do not receive group exercise intervention

NO INTERVENTION

Participants will participate in pre and post-testing.

Interventions

Group fitness program

Participants who receive group exercise intervention

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Holly L Ingham, DPT

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Holly Ingham, DPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Individuals completing pre and post-testing will be blinded to if the participate received the intervention or not.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2023

First Posted

September 29, 2023

Study Start

October 23, 2024

Primary Completion

March 31, 2025

Study Completion

May 31, 2025

Last Updated

November 30, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share