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

November 28, 2023 updated by: University of Colorado, Denver
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?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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.

    -

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants who receive group exercise intervention
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
Group fitness program
No Intervention: Participants who do not receive group exercise intervention
Participants will participate in pre and post-testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Strength Tests
Time Frame: 30 second intervals
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Investigators

  • Principal Investigator: Holly L Ingham, DPT, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 23, 2024

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 25, 2023

First Posted (Actual)

September 29, 2023

Study Record Updates

Last Update Posted (Actual)

November 30, 2023

Last Update Submitted That Met QC Criteria

November 28, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23-0605

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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