Teleexercise Methods for Improving Physical Activity

(FITWITHUS Trial)

Overseen By Sangeetha Mohanraj, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Significant visual impairment, Exercising 6 months, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

257 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of this treatment?

Research shows that web-based physical activity programs, including video coaching and adaptive interventions, can improve engagement and adherence to exercise routines. These methods have been effective in various groups, such as inactive adults and older adults, suggesting they may help increase physical activity levels. ^{1 2 3 4 5}

Is teleexercise safe for humans?

Research indicates that teleexercise methods, such as live online group training sessions for older adults, are generally safe. In a study with older adults, no adverse events were reported, and participants showed high adherence and satisfaction with the program. ^{1 3 6 7 8}

How is the Teleexercise treatment different from other physical activity interventions?

The Teleexercise treatment is unique because it uses adaptive interventions, which adjust the components or intensity based on the participant's progress, and it incorporates various combinations of asynchronous content, health coaching, and live training to increase physical activity. This approach leverages technology to provide personalized and flexible support, making it accessible and potentially more effective for diverse populations. ^{3 5 9 10 11}

What is the purpose of this trial?

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 another 8 weeks. After final surveys, participants will have open access to the website for another 16 weeks where we will passively observe their fitbit and website data. The study outcomes are: The effectiveness of the adaptive interventions Exploring mediating and moderating variables Sensitivity analysis of the predictive analytics

Research Team

Mohanraj Thirumalai, PhD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for individuals aged 18 to 64 with permanent mobility impairments who have internet access and can converse in English. It's not suitable for those who've been exercising regularly for the past 6 months or have significant visual issues preventing them from seeing a computer screen.

Inclusion Criteria

I have a long-term disability that affects my ability to move.

Has internet access

Can converse in English

Exclusion Criteria

Has been exercising for the past 6 months or longer

I cannot see well enough to follow exercises on a computer screen.

Timeline

Run-in

Participants consent to the study, complete baseline surveys, and receive exercise tracking devices and orientation.

2 weeks

1 orientation call

Adoption

Participants engage in pre-recorded exercise content. Non-responders receive live training.

8 weeks

Up to 8 health coaching calls, 3 live training sessions per week for non-responders

Maintenance

Participants receive asynchronous exercise content and complete final surveys.

8 weeks

Final survey packet

Follow-up

Participants have open access to the website and are monitored for activity data.

16 weeks

Passive data collection

Treatment Details

Interventions

• Asynchronous content and group training
• Asynchronous content and health coaching and 1 on 1 training
• Asynchronous content and health coaching and group training
• Asynchronous content and health coaching and no live training
• Asynchronous content only
• Asynchronous content only and 1 on 1 live training

Trial Overview The study tests various sequences of delivering teleexercise and health coaching, using SMART design to adapt interventions based on participant adherence. Participants will receive different combinations of recorded content, live training, and health coaching over a period of 32 weeks.

Participant Groups

Group I: asynchronous exercise responder Experimental Treatment 1 Intervention

Individuals only receiving asynchronous exercise content and are responding

Group II: Asynchronous exercise non-responder and group live training Experimental Treatment 1 Intervention

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

Group III: Asynchronous exercise non-responder and 1 on 1 live training Experimental Treatment 1 Intervention

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

Group IV: Asynchronous exercise and health coaching responder Experimental Treatment 1 Intervention

Individuals receiving asynchronous exercise content and health coaching and are responding

Group V: Asynchronous exercise and health coaching non-responder and group live training Experimental Treatment 1 Intervention

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

Group VI: Asynchronous exercise and health coaching non-responder and 1 on 1 live training Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

The study involved 151 inactive adults and assessed the feasibility and effectiveness of adding brief video coaching to a computer-tailored physical activity intervention, showing that participants who engaged in video coaching had improved adherence and engagement compared to those who did not.

While all groups increased their physical activity over 9 weeks, the video-coaching group showed a significantly greater increase compared to the control group, indicating that video coaching can enhance the effectiveness of web-based interventions, although the overall impact was modest.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Video-Coaching to Assist an Automated Computer-Tailored Physical Activity Intervention for Inactive Adults: A Randomized Controlled Trial. Alley, S., Jennings, C., Plotnikoff, RC., et al.[2022]

A study involving 305 participants with musculoskeletal conditions found that a web-based exercise programming system significantly improved adherence to home exercise programs compared to traditional methods, with notable differences in overall adherence and specific exercise metrics.

Participants using the web-based system reported greater confidence in their ability to perform prescribed exercises, although both groups had similar satisfaction levels with the exercise delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does a Web-Based Exercise Programming System Improve Home Exercise Adherence for People With Musculoskeletal Conditions?: A Randomized Controlled Trial. Bennell, KL., Marshall, CJ., Dobson, F., et al.[2020]

A 16-week randomized controlled trial with 41 healthy older adults showed that a home-based training program delivered via videoconference was as effective as face-to-face training in reducing body weight and fat mass, and improving cardiorespiratory fitness and lower limb strength.

While videoconferencing training was effective for many fitness measures, it was less effective than face-to-face training for improving certain strength metrics like handgrip and trunk extension strength.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-inferiority of a home-based videoconference physical training program in comparison with the same program administered face-to-face in healthy older adults: the MOTION randomised controlled trial. Langeard, A., Bigot, L., Maffiuletti, NA., et al.[2022]

The Internet-based physical activity support program (IPAS) did not show significant improvements in moderate-to-vigorous physical activity (MVPA) or secondary outcomes among 137 cancer survivors compared to a control group after 6 months.

Blended care, which included physiotherapist telephone counseling, received better satisfaction scores than online-only support, but overall adherence to the program was low, indicating a need for improved accessibility and support in future trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of and Lessons Learned from an Internet-Based Physical Activity Support Program (with and without Physiotherapist Telephone Counselling) on Physical Activity Levels of Breast and Prostate Cancer Survivors: The PABLO Randomized Controlled Trial. van de Wiel, HJ., Stuiver, MM., May, AM., et al.[2021]

An adaptive intervention for physical activity, which adjusted daily step goals based on individual performance, led to a significant increase in steps per day (2,728 steps) compared to a static intervention (1,598 steps) over a 6-month period with 20 participants.

The study demonstrated that the adaptive approach was more effective in promoting physical activity, suggesting that such dynamic goal-setting methods could be integrated into mobile health technologies to benefit larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An adaptive physical activity intervention for overweight adults: a randomized controlled trial. Adams, MA., Sallis, JF., Norman, GJ., et al.[2022]

This study will evaluate the effectiveness of a web-based physical activity intervention using personalized videos compared to a traditional text-based approach and a control group, involving 510 participants over a 3-month period.

The primary outcome measured will be objectively assessed physical activity levels, with secondary outcomes including engagement, quality of life, and mental health indicators, providing a comprehensive view of the intervention's impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TaylorActive--Examining the effectiveness of web-based personally-tailored videos to increase physical activity: a randomised controlled trial protocol. Vandelanotte, C., Short, C., Plotnikoff, RC., et al.[2019]

A newly designed online physical activity protocol delivered via video-conferencing was found to be safe and feasible for older adults, with no adverse events reported during the 8-week study involving 31 participants.

The protocol achieved a high adherence rate of 90%, and 97% of participants expressed interest in continuing such programs, indicating strong satisfaction with the exercise sessions and their delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staying physically active during the COVID-19 quarantine: exploring the feasibility of live, online, group training sessions among older adults. Schwartz, H., Har-Nir, I., Wenhoda, T., et al.[2021]

A pilot study involving 38 older adults showed that a four-week home-based resistance 'exercise snacking' program was feasible and safe, with high adherence rates (97% for once daily, 82% for twice daily, and 81% for thrice daily) and only two adverse events reported from 1317 sessions.

Participants found the exercise enjoyable and easy to perform, with 82% planning to continue similar exercises at home, indicating strong acceptability for this remote intervention strategy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a remotely delivered, home-based, pragmatic resistance 'exercise snacking' intervention in community-dwelling older adults: a pilot randomised controlled trial. Fyfe, JJ., Dalla Via, J., Jansons, P., et al.[2022]

An 8-week randomized trial involving 655 university staff found no significant overall increase in physical activity from either a print or a web-based intervention, indicating that both methods may be equally ineffective in increasing activity levels.

However, the print program was effective for participants who were inactive at the start, showing a significant increase in physical activity, while the web program led to a notable decrease in sitting time, suggesting different impacts based on the delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Print versus website physical activity programs: a randomized trial. Marshall, AL., Leslie, ER., Bauman, AE., et al.[2019]

A web-based program called Young & Active was developed to increase physical activity among overweight adolescents, incorporating features like self-monitoring, autonomy-supportive counseling, and social support forums, based on theories of self-determination and motivational interviewing.

Usability testing with adolescents aged 12-16 showed that the program was well accepted after iterative adjustments, indicating a strong foundation for further evaluation of its efficacy in a controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and usability testing of an internet intervention to increase physical activity in overweight adolescents. Riiser, K., Løndal, K., Ommundsen, Y., et al.[2021]

The study involved 59 older adults and 81 university students, using video communication to assess physical performance through tasks like sit-to-stand, demonstrating that older adults can be effectively monitored for motor function from home.

Results indicated that video-based measurements of maximum velocities during sit-to-stand tasks can estimate muscular strength in older adults, suggesting that remote monitoring can enhance their participation in fitness programs and support their overall wellness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the sit-to-stand task to evaluate motor function of older adults using telemetry. Kanai, A., Kiyama, S., Goto, H., et al.[2018]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Web-Based Video-Coaching to Assist an Automated Computer-Tailored Physical Activity Intervention for Inactive Adults: A Randomized Controlled Trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Does a Web-Based Exercise Programming System Improve Home Exercise Adherence for People With Musculoskeletal Conditions?: A Randomized Controlled Trial. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Non-inferiority of a home-based videoconference physical training program in comparison with the same program administered face-to-face in healthy older adults: the MOTION randomised controlled trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of and Lessons Learned from an Internet-Based Physical Activity Support Program (with and without Physiotherapist Telephone Counselling) on Physical Activity Levels of Breast and Prostate Cancer Survivors: The PABLO Randomized Controlled Trial. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

An adaptive physical activity intervention for overweight adults: a randomized controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

TaylorActive--Examining the effectiveness of web-based personally-tailored videos to increase physical activity: a randomised controlled trial protocol. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Staying physically active during the COVID-19 quarantine: exploring the feasibility of live, online, group training sessions among older adults. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of a remotely delivered, home-based, pragmatic resistance 'exercise snacking' intervention in community-dwelling older adults: a pilot randomised controlled trial. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Print versus website physical activity programs: a randomized trial. [2019]

10. Canada pubmed.ncbi.nlm.nih.gov

Development and usability testing of an internet intervention to increase physical activity in overweight adolescents. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Use of the sit-to-stand task to evaluate motor function of older adults using telemetry. [2018]