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Recruiting NCT06207084

NCT06207084 The Fit With Us Study

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Clinical Trial Summary
NCT ID NCT06207084
Status Recruiting
Phase
Sponsor University of Alabama at Birmingham
Condition Mobility Limitations
Study Type INTERVENTIONAL
Enrollment 257 participants
Start Date 2024-09-01
Primary Completion 2028-02-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 89 Years
Study Type INTERVENTIONAL
Interventions
asynchronous content onlyAsynchronous content and health coaching and no live trainingasynchronous content only and 1 on 1 live training

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 257 participants in total. It began in 2024-09-01 with a primary completion date of 2028-02-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The purpose of this 32-week study is to use an innovative experimental design known as SMART (Sequential Multiple Assignment Randomized Trial), which will allow us to determine the best way to sequence the delivery of teleexercise (referred to as an adaptive intervention), combined with predictive analytics on participant adherence in a stepped program of physical activity interventions. All 257 participants will have access to a library of recorded video exercise content, and a weekly wellness article. Some participants will receive health coaching calls (1st randomization). Analytic data will be used to determine which participants are responding or not responding to the intervention. Participants not responding after 4 weeks will receive either live one-on-one or group exercise training (2nd randomization). After 8 weeks, the participant will receive only pre-recorded exercise content and articles for a 24-week maintenance phase (weeks 9-32). The study outcomes are: The effectiveness of the adaptive interventions; Exploring mediating and moderating variables; Sensitivity analysis of the predictive analytics.

Eligibility Criteria

Eligible participants must meet the following criteria to be included: (1) live with a permanent physical disability that limits their mobility; (2) be 18 to 89 years of age; (3) have broadband internet access; (4) be able to speak and read English; and (5) be able to attend coaching and training sessions during the weekdays. Participants are excluded from participation if they (1) possess significant visual acuity that prevents seeing a computer screen to follow a home exercise program; (2) have been regularly engaging in exercise for the previous 3 months; (3) are unable to use their arms and their legs at all to exercise; (4) are unsafe to exercise; (5) self-report that they are currently pregnant

Contact & Investigator

Central Contact

Mohanraj Thirumalai, PhD

✉ mohanraj@uab.edu

📞 205-934-7189

Principal Investigator

Mohanraj Thirumalai, PhD

PRINCIPAL INVESTIGATOR

University of Alabama at Birmingham

Frequently Asked Questions

Who can join the NCT06207084 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Mobility Limitations. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06207084 currently recruiting?

Yes, NCT06207084 is actively recruiting participants. Contact the research team at mohanraj@uab.edu for enrollment information.

Where is the NCT06207084 trial being conducted?

This trial is being conducted at Birmingham, United States.

Who is sponsoring the NCT06207084 clinical trial?

NCT06207084 is sponsored by University of Alabama at Birmingham. The principal investigator is Mohanraj Thirumalai, PhD at University of Alabama at Birmingham. The trial plans to enroll 257 participants.

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