Smartphone Feedback for Physical Activity in Spinal Cord Injury

Overseen By Shivayogi V Hiremath, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Temple University

Disqualifiers: Cardiovascular disease, Pressure injuries, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 8

196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help individuals with spinal cord injuries (SCI) increase physical activity through smartphone feedback. It compares a web-based exercise program alone to the same program enhanced with a just-in-time adaptive intervention (JITAI), which offers timely, personalized activity suggestions. Participants who have had an SCI for at least six months, primarily use a wheelchair, and can exercise using their arms may be suitable candidates. The goal is to determine if the added feedback encourages more activity than the web program alone. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to innovative SCI care solutions.

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 prior data suggests that this intervention strategy is safe for individuals with spinal cord injury?

A previous study suggested that the web-based physical activity program (WI) was well-received and easy for participants to use. It showed promise in helping people with spinal cord injuries (SCI) increase their exercise levels without major issues. The program was considered feasible, meaning it was practical and doable for those involved.

Early findings suggest that the JITAI (just-in-time adaptive intervention) physical activity message can effectively increase physical activity in people with SCI. This approach provides personalized feedback and suggestions at the right time for each person. Initial evidence indicated it was safe and did not cause significant problems for those who tried it.

Overall, the safety of these treatments looks promising. However, this study is still in an early phase, so more research is needed to confirm these results. Since these treatments are not yet fully approved, participants should continue receiving updates and guidance from their healthcare providers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they aim to enhance physical activity for individuals with spinal cord injury using personalized and adaptive technology. Unlike standard care options, which often involve generalized exercise programs, the JITAI approach offers just-in-time feedback and recommendations tailored to the individual's needs and activities. This micro-randomization technique allows for real-time, personalized interventions that can adapt to the user's circumstances, potentially leading to more effective engagement and sustained physical activity. By merging this with a web-based program, participants receive continuous support and motivation, which could significantly improve their overall health and quality of life.

What evidence suggests that this trial's treatments could be effective for increasing physical activity in individuals with spinal cord injury?

Research has shown that online exercise programs, like the WI program, can help people with spinal cord injuries (SCI) become more active. These programs motivate users and help them overcome challenges to staying active. In this trial, one group of participants will receive the WI program alone, while another group will receive the WI program combined with a just-in-time adaptive intervention (JITAI). Studies have found that adding JITAI to these programs can further increase physical activity by providing real-time feedback and personalized tips to encourage more movement. This combination is expected to lead to even greater improvements in activity levels for individuals with SCI. ^{1 2 3 4 6}

Who Is on the Research Team?

Shivayogi V Hiremath, PhD

Principal Investigator

Temple University

Are You a Good Fit for This Trial?

This trial is for individuals aged 18-75 with spinal cord injury at C5 level or below, who are at least 6 months post-injury. They must primarily use a wheelchair and be able to exercise using their arms. Participants should be ready for physical activity and experienced in using smartphones and smartwatches. Those with medical conditions restricting activity or traumatic brain injury cannot join.

Inclusion Criteria

I mainly use a wheelchair to get around.

I had a spinal cord injury at least 6 months ago.

Participants who show readiness to physical activity as assessed by the Physical Activity Readiness Questionnaire

Exclusion Criteria

I have been diagnosed with a traumatic brain injury.

I have health issues like heart disease or infections that limit my activities.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Baseline

Baseline assessments including non-traumatic SCI, age, sex, race/ethnicity, SCI level of injury, and functional level

2 weeks

2 visits (in-person)

WI Program

Participants engage in the web-based physical activity intervention program

14 weeks

3 visits (virtual)

WI + JITAI Program

Participants receive just-in-time adaptive interventions alongside the WI program

14 weeks

Micro-randomized feedback sessions (virtual)

Physical Activity Sustainability

Participants continue to have access to the WI program information and JITAI feedback

8 weeks

Ongoing virtual access

Follow-up

Participants are monitored for sustained physical activity levels and other health outcomes

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• JITAI Goal Setting
• JITAI physical activity message
• WI program
• WI Program Reminder

Trial Overview The study tests a web-based physical activity program combined with just-in-time adaptive interventions (JITAI) delivered through smartphones to boost physical activity in people with spinal cord injuries. It aims to see if this tech-enhanced approach is more effective than the standard web-based program alone.

How Is the Trial Designed?

Group I: Web-based physical activity intervention (WI) program + just-in-time adaptive intervention (JITAI) Experimental Treatment 9 Interventions

Participants in the WI + JITAI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24). In addition, participants will have access to the JITAI that will provide just-in-time feedback and physical activity recommendations (weeks 3 to 24). The type of the feedback and recommendation messages in the WI + JITAI arm will be delivered using micro-randomization, which involves random selection of intervention components at each possible time of delivery.

Group II: Web-based physical activity intervention (WI) program Active Control 3 Interventions

Participants in the WI arm will take part in the WI program (weeks 3 to 16). After the WI program is completed in week 16, the participants will transition to the physical activity sustainability phase which will include participants having continued access to the information provided during the WI program (weeks 17 to 24).

JITAI physical activity message is already approved in United States for the following indications:

Approved in United States as JITAI Physical Activity Message for:

• Increasing physical activity levels in individuals with spinal cord injury

Who Is Running the Clinical Trial?

Temple University

Lead Sponsor

Trials

321

Recruited

89,100+

Good Shepherd Rehabilitation Network

Collaborator

Trials

2

Recruited

260+

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Northeastern University

Collaborator

Trials

103

Recruited

72,600+

Albert Einstein Healthcare Network

Collaborator

Trials

65

Recruited

869,000+

Thomas Jefferson University

Collaborator

Trials

475

Recruited

189,000+

Magee Rehabilitation Hospital, Jefferson Health

Collaborator

Trials

2

Recruited

220+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

A study involving 11 adults with incomplete spinal cord injury found that a minimum of 2 days of step activity monitoring is needed to reliably measure walking activity, achieving a reliability coefficient of 0.80.

The average daily step count for participants was 1,281 steps, indicating that even short monitoring periods can provide stable measures for evaluating the effectiveness of activity-based rehabilitation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of daily step activity monitoring in adults with incomplete spinal cord injury. Ishikawa, S., Stevens, SL., Kang, M., et al.[2019]

The Apple Watch Series 4 shows a significant improvement in measuring wheelchair pushes for users with spinal cord injury, with a mean absolute percent error (MAPE) of 9.20%, indicating it can effectively track physical activity in this population.

In comparison to the older Series 1, the Series 4 provides more accurate data, making it a promising tool for objectively measuring physical activity in wheelchair users, although it tends to overestimate the number of pushes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measurement Performance of Activity Measurements with Newer Generation of Apple Watch in Wheelchair Users with Spinal Cord Injury. Benning, NH., Knaup, P., Rupp, R.[2022]

Individuals with spinal cord injury (SCI) prefer passive sources like the Internet and DVDs for receiving physical activity information, highlighting the importance of accessible media.

Peers and health service providers are seen as the most trusted messengers for delivering physical activity messages, indicating a need for collaboration among healthcare professionals to tailor information for different stages of recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. Letts, L., Martin Ginis, KA., Faulkner, G., et al.[2022]

A study involving 13 individuals with spinal cord injury (SCI) and 9 healthcare professionals identified key features for a web-based self-management physical activity portal, emphasizing the importance of knowledge, self-regulation strategies, and interactivity to motivate physical activity engagement.

Participants rated the likelihood of using and promoting the portal highly, indicating strong interest in a tailored online platform that could help individuals with SCI manage their condition and increase physical activity adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Physical Activity Portal for Individuals Living With a Spinal Cord Injury: Qualitative Study. Pancer, M., Manganaro, M., Pace, I., et al.[2020]

The Physical Activity Instrument-SCI (PAI-SCI) demonstrated a moderate correlation with accelerometer data, indicating it can reliably assess physical activity levels in individuals with spinal cord injuries, with a correlation coefficient of r = 0.42.

The PAI-SCI effectively differentiated physical activity levels between individuals with upper and lower level spinal cord injuries, but its reliability varied across different activity subscales, suggesting further research is needed before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical Activity Inventory for Patients with Spinal Cord Injury. Butler, JA., Miller, T., O'Connell, S., et al.[2021]

A mobile health-based system was used to track physical activity (PA) levels in 20 individuals with spinal cord injury (SCI) over three phases, showing that 69% of participants increased their light- and moderate-intensity PA when provided with just-in-time adaptive interventions (JITAI).

This pilot study suggests that using a sensor-enabled mobile JITAI can effectively promote higher PA levels in individuals with SCI, indicating a promising direction for future research to further evaluate its efficacy in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health-based physical activity intervention for individuals with spinal cord injury in the community: A pilot study. Hiremath, SV., Amiri, AM., Thapa-Chhetry, B., et al.[2020]

A study involving 19 manual wheelchair users with chronic spinal cord injury found that accelerometers and self-reported assessments of physical activity showed low agreement, indicating that they measure different aspects of physical activity.

While accelerometers were effective in detecting brief or intermittent activities, the self-report measure was better for capturing activities like resistance training and wheeling on inclines, suggesting that using both methods together may provide a more comprehensive view of physical activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical activity measurement in people with spinal cord injury: comparison of accelerometry and self-report (the Physical Activity Recall Assessment for People with Spinal Cord Injury). Ma, JK., McCracken, LA., Voss, C., et al.[2021]

The Accessercise smartphone app was developed to improve physical activity in individuals with spinal cord injuries (SCI) by targeting 13 specific behaviors, such as goal setting and increasing self-confidence, which are crucial for reducing sedentary lifestyles.

Using the Behaviour Change Wheel (BCW) framework, the study identified key mechanisms that could enhance the app's effectiveness, suggesting that it could serve as a model for future interventions aimed at improving health outcomes for people with SCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applying the behaviour change wheel to assess the theoretical underpinning of a novel smartphone application to increase physical activity in adults with spinal cord injuries. Haley, JA., Rhind, DJA., Maidment, DW.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11245659/

mHealth-Based Just-in-Time Adaptive Intervention to Improve ... Regular PA and exercise-based interventions have been linked with improved outcomes and healthier lifestyles among those with SCI. Providing people with an ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05317832

Using Smartphones to Improve Physical Activity Levels of ... The overarching goal of this research study is to evaluate a sensor-enabled, just-in-time adaptive intervention (JITAI) strategy to increase and sustain ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38941145/

mHealth-Based Just-in-Time Adaptive Intervention to Improve ... The primary aim of this study is to investigate whether minutes of moderate-intensity PA among individuals with SCI can be increased by integrating a JITAI ...

4. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0223762

Mobile health-based physical activity intervention for ... Regular PA and exercise interventions have been linked with improved outcomes and healthier lifestyles among individuals with SCI [3]. To ...

5. researchprotocols.org researchprotocols.org/2023/1/e47665

Increasing Physical Activity in Persons With Spinal Cord ... The primary aim of this study is to test the feasibility of a tele-exercise program that applies an adaptive intervention design for 30 adults with SCI.

6. withpower.com withpower.com/trial/smartphone-feedback-for-physical-activity-in-spinal-cord-injury-7f8ee

Smartphone Feedback for Physical Activity in Spinal Cord Injury This Phase 2 medical study run by Temple University is evaluating whether JITAI physical activity message and WI program will have tolerable side effects ...