Fitness TestingNCT06758310
Exercise Effects in Native American Adolscents
A study testing Individualized Exercise in people with Fitness Testing, run by Midwestern University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Fitness Testing
- What is being tested?
- Individualized Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2025to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Active members of the Gila River Indian Community (GRIC) with Native American ancestry
- Ages 11-17
Who cannot join
- Not active members of the GRIC or no Native American ancestry
- Age <11 or >17
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Fitness Testing
- Being tested
- Individualized Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized ExerciseOther
Each participant will be prescribed an individualized exercise program related to their fitness testing results and personal interests.
| Study group | Role | What they receive |
|---|---|---|
| Individualized exercise | Experimental | Not described Receives: Other: Individualized Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Push ups
Performed in 1 min
Measured: 6 weeks
Sit ups
Performed in 1 min
Measured: 6 weeks
Sit and Reach
Flexibility assessment
Measured: 6 weeks
1 mile run
For time
Measured: 6 weeks
Resting Heart Rate
Measured: 6 weeks
Secondary outcomes (1)
Blood Pressure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2025
- Study start16 Nov 2025 (estimated)
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fitness TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joshua Subialka, Midwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06758310
- Sponsor's protocol ID
- IRB-24-0013
- Status last verified
- Sep 2025
- First submitted
- 26 Dec 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Individualized Exercise Program on Physical Performance Measures in Southwest Native American Adolescents
- ClinicalTrials.gov ID
- NCT06758310
- Acronym / sponsor ID
- IRB-24-0013
- Conditions
- Fitness Testing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 16 Nov 2025 (estimated)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 3 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individualized exercise | Experimental | Other: Individualized Exercise |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Active members of the Gila River Indian Community (GRIC) with Native American ancestry
- Ages 11-17
Key exclusion criteria (2 listed)
- Not active members of the GRIC or no Native American ancestry
- Age <11 or >17
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Individualized ExerciseEach participant will be prescribed an individualized exercise program related to their fitness testing results and personal interests. | Other | Individualized exercise |
Primary outcome
Push ups
Time frame: 6 weeks
Performed in 1 min
Sit ups
Time frame: 6 weeks
Performed in 1 min
Sit and Reach
Time frame: 6 weeks
Flexibility assessment
1 mile run
Time frame: 6 weeks
For time
Resting Heart Rate
Time frame: 6 weeks
1 secondary outcome
Blood Pressure
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Exercise in people with Fitness Testing, run by Midwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josh Subialka, DPT, DSc (763-228-6370, jsubia@midwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Push ups (time frame: 6 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.