NCT06758310

Brief 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. 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.

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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

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

December 26, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2025

Completed
11 months until next milestone

Study Start

First participant enrolled

November 16, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2025

Completed
Last Updated

September 25, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

December 26, 2024

Last Update Submit

September 24, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • Push ups

    Performed in 1 min

    6 weeks

  • Sit ups

    Performed in 1 min

    6 weeks

  • Sit and Reach

    Flexibility assessment

    6 weeks

  • 1 mile run

    For time

    6 weeks

  • Resting Heart Rate

    6 weeks

Secondary Outcomes (1)

  • Blood Pressure

    6 weeks

Study Arms (1)

Individualized exercise

EXPERIMENTAL
Other: Individualized Exercise

Interventions

Each participant will be prescribed an individualized exercise program related to their fitness testing results and personal interests.

Individualized exercise

Eligibility Criteria

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

You may qualify if:

  • Active members of the Gila River Indian Community (GRIC) with Native American ancestry
  • Ages 11-17

You may not qualify if:

  • Not active members of the GRIC or no Native American ancestry
  • Age \<11 or \>17

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Josh Subialka, DPT, DSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 26, 2024

First Posted

January 3, 2025

Study Start

November 16, 2025

Primary Completion

December 20, 2025

Study Completion

December 20, 2025

Last Updated

September 25, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share