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

Primary Purpose

Cognitive Impairment

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group exercise program
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairment

Eligibility Criteria

11 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. - Exclusion Criteria: 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. -

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Participants who receive group exercise intervention

    Participants who do not receive group exercise intervention

    Arm Description

    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.

    Participants will participate in pre and post-testing.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    September 25, 2023
    Last Updated
    September 25, 2023
    Sponsor
    University of Colorado, Denver
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06061900
    Brief Title
    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

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 23, 2023 (Anticipated)
    Primary Completion Date
    March 31, 2024 (Anticipated)
    Study Completion Date
    May 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Colorado, Denver

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Impairment

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Outcomes Assessor
    Masking Description
    Individuals completing pre and post-testing will be blinded to if the participate received the intervention or not.
    Allocation
    Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Participants who receive group exercise intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Participants who do not receive group exercise intervention
    Arm Type
    No Intervention
    Arm Description
    Participants will participate in pre and post-testing.
    Intervention Type
    Other
    Intervention Name(s)
    Group exercise program
    Intervention Description
    Group fitness program
    Primary Outcome Measure Information:
    Title
    6 Minute Walk Test
    Description
    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.
    Time Frame
    6 minutes
    Secondary Outcome Measure Information:
    Title
    Functional Strength Tests
    Description
    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.
    Time Frame
    30 second intervals

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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. - Exclusion Criteria: 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. -
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Holly Ingham, DPT
    Phone
    7202902569
    Email
    holly.ingham@anschutz.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Holly L Ingham, DPT
    Organizational Affiliation
    University of Colorado, Denver
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30973765
    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.
    Results Reference
    result
    PubMed Identifier
    35445495
    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.
    Results Reference
    result
    PubMed Identifier
    26079525
    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.
    Results Reference
    result
    PubMed Identifier
    31947891
    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.
    Results Reference
    result
    PubMed Identifier
    28818714
    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.
    Results Reference
    result

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

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