- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06758310
Exercise Effects in Native American Adolscents
September 24, 2025 updated by: Joshua Subialka, Midwestern University
Effects of an Individualized Exercise Program on Physical Performance Measures in Southwest Native American Adolescents
This longitudinal study will investigate effects of exercise participation in Southwest Native American adolescents, ages 11-17, from the Gila River Indian Community.
Vital signs, physical activity participation adherence, physical performance measures, and psychological/social measures will be assessed.
Participants will attend one educational presentation for the initial session, explaining the benefits of physical exercise and expectations throughout the program.
Baseline measurements for strength, flexibility, and cardiovascular fitness will be taken as well as height, weight and blood pressure.
Based on individual performance measures, each participant will be provided a personalized exercise program to complete 3-4 times/week for the duration for the duration of the study.
Participants will also be provided an exercise journal to track their adherence to their exercise program each week.
At the end of the session parents and adolescents separately will be asked to complete a written survey assessing physical, emotional, social, and school function.
Physical performance measures will be taken every other week from the initial education and data collection session through 6 weeks.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
10
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
- Name: Josh Subialka, DPT, DSc
- Phone Number: 763-228-6370
- Email: jsubia@midwestern.edu
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:
- Active members of the Gila River Indian Community (GRIC) with Native American ancestry
- Ages 11-17
Exclusion Criteria:
- Not active members of the GRIC or no Native American ancestry
- Age <11 or >17
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individualized exercise
|
Each participant will be prescribed an individualized exercise program related to their fitness testing results and personal interests.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Push ups
Time Frame: 6 weeks
|
Performed in 1 min
|
6 weeks
|
|
Sit ups
Time Frame: 6 weeks
|
Performed in 1 min
|
6 weeks
|
|
Sit and Reach
Time Frame: 6 weeks
|
Flexibility assessment
|
6 weeks
|
|
1 mile run
Time Frame: 6 weeks
|
For time
|
6 weeks
|
|
Resting Heart Rate
Time Frame: 6 weeks
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood Pressure
Time Frame: 6 weeks
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
November 16, 2025
Primary Completion (Estimated)
December 20, 2025
Study Completion (Estimated)
December 20, 2025
Study Registration Dates
First Submitted
December 26, 2024
First Submitted That Met QC Criteria
December 26, 2024
First Posted (Actual)
January 3, 2025
Study Record Updates
Last Update Posted (Estimated)
September 25, 2025
Last Update Submitted That Met QC Criteria
September 24, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- IRB-24-0013
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
product manufactured in and exported from the U.S.
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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