Recruiting

Observational Study

Sponsor:

University of Alabama at Birmingham

Code:

NCT06207084

Conditions

Mobility Limitations

Disability Physical

Telehealth

Health Coaching

Physical Activity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

asynchronous content only

Asynchronous content and health coaching and no live training

asynchronous content only and 1 on 1 live training

asynchronous content and health coaching and 1 on 1 training

asynchronous content and group training

Study Details

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.

Conditions

Mobility Limitations

Disability Physical

Telehealth

Health Coaching

Physical Activity

Study ID

NCT06207084

Start date

Sep 1, 2024

Status verified date

Jan, 2026

Completion date

Feb 1, 2029

Anticipated

Primary completion date

Feb 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

257 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: asynchronous exercise responder

Individuals only receiving asynchronous exercise content and are responding

experimental: Asynchronous exercise and health coaching responder

Individuals receiving asynchronous exercise content and health coaching and are responding

experimental: Asynchronous exercise non-responder and 1 on 1 live training

Individuals receiving asynchronous exercise content and are not responding. The are receiving 1 on 1 live exercise sessions.

experimental: Asynchronous exercise and health coaching non-responder and 1 on 1 live training

Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving 1 on 1 live exercise sessions.

experimental: Asynchronous exercise non-responder and group live training

Individuals receiving asynchronous exercise content and are not responding. The are receiving group live exercise sessions.

experimental: Asynchronous exercise and health coaching non-responder and group live training

Individuals receiving asynchronous exercise content and health coaching and are not responding. The are receiving group live exercise sessions.

Interventions

asynchronous content only

Receives asynchronous exercise content and no live training

Asynchronous content and health coaching and no live training

Receives asynchronous content, health coaching and no live training.

asynchronous content only and 1 on 1 live training

receives asynchronous content and live 1 on 1 training

asynchronous content and health coaching and 1 on 1 training

receives asynchronous content, health coaching, and live training

asynchronous content and group training

receives asynchronous content and live group training

Asynchronous content and health coaching and group training

receives asynchronous content, health coaching, and live group training

Primary outcome measure

  • Physical activity [ Time Frame: Fitbit: ongoing for 32 weeks; Godin: Baseline, week 8, week 16, and week 32 ]

Central Contacts and Locations

Central contacts

Mohanraj Thirumalai, PhD

205-934-7189mohanraj@uab.edu

Sangeetha Mohanraj, MS

205-975-0550sangee@uab.edu

Locations

Wellness, Health and Research Facility

Recruiting

Birmingham, Alabama, United States, 35209

Contacts

Ayse G Zengul, PhD

659 2733627aysezen@uab.edu

Principal Investigator:

Mohanraj Thirumalai, PhD

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Jan 9, 2026

Last verified

Jan, 2026

Keywords

  • telehealth
  • health coaching
  • disability

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-01-09.