Smartwatches for Sedentary Lifestyle

(EIM+ Trial)

Overseen By Toluwa C Nafiu, B.S.

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Coronary artery disease, Stroke, Congestive heart failure, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether providing smartwatches to people aged 65 and older can help increase their activity levels. The goal is to determine if increased physical activity can prevent or manage chronic diseases such as heart disease, diabetes, and depression. Participants will join the Exercise is Medicine program (EIM+), which promotes exercise to improve health and quality of life. Individuals without serious heart issues or physical activity limitations may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance health and quality of life for seniors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on increasing physical activity with the use of smartwatches, so it's best to consult with the trial coordinators or your healthcare provider for guidance.

What prior data suggests that using smartwatches in the Exercise is Medicine Program is safe for participants aged 65+?

Research has shown that wearable devices like smartwatches are generally safe and help track physical activity while reminding users to move. Studies have found that these devices can encourage increased activity, especially in individuals with long-term health conditions.

The Exercise is Medicine program, included in this study, helps people incorporate exercise into their daily routines. These programs are designed to be safe and have received positive feedback from many participants.

Although specific data on side effects is lacking, smartwatches and the Exercise is Medicine program have been used elsewhere without major safety issues, suggesting they are likely safe for most people. However, individual experiences can vary, so discussing any concerns with a healthcare provider is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EIM+ treatment for sedentary lifestyles because it takes a unique approach by combining an exercise program with smartwatch technology. Unlike traditional methods that rely on gym sessions or personal trainers, EIM+ leverages real-time data and reminders from smartwatches to motivate and engage participants in their daily activities. This tech-driven method aims to seamlessly integrate physical activity into everyday life, potentially leading to more sustainable behavior changes and improved health outcomes.

What evidence suggests that using smartwatches in the Exercise is Medicine Program is effective for increasing physical activity in older adults?

Research has shown that exercise effectively prevents and manages long-term illnesses such as heart disease, type 2 diabetes, and depression. In this trial, participants will receive the Exercise is Medicine Plus (EIM+) program, which includes a smartwatch to help older adults stay active. Studies have found that people using these devices tend to move more and experience fewer days of feeling unwell compared to those who don't use them. Wearable technology, like smartwatches, can increase step count and improve symptoms of various health issues. Overall, the EIM+ program can enhance quality of life by encouraging regular physical activity. ^{1 4 6 7 8}

Who Is on the Research Team?

Joshua Joseph, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for individuals aged 65 and older who lead a sedentary lifestyle, may be obese, and are interested in using smartwatches to increase their physical activity. The details of inclusion and exclusion criteria were not provided.

Inclusion Criteria

No healthcare provider-imposed limitations on physical activity

English-speaking

I am 65 years old or older.

Exclusion Criteria

I have a serious heart valve problem.

Blood pressure >160/100 mmHg

Inability to independently manage blood glucose during activity

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Exercise is Medicine program along with a smartwatch to increase physical activity levels

12 months

Regular monitoring through smartwatch tracking

Follow-up

Participants are monitored for changes in physical activity, health metrics, and quality of life after program completion

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EIM+

Trial Overview The study tests the feasibility and acceptability of incorporating smartwatches into an existing Exercise is Medicine Program at Ohio State University Wexner Medical Center to boost physical activity among older adults.

How Is the Trial Designed?

Group I: Exercise is Medicine Plus Experimental Treatment 1 Intervention

Participants receiving the Exercise is Medicine program along with a smartwatch.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

Published Research Related to This Trial

Electronic Activity Monitor Systems (EAMSs) show promise in increasing physical activity and reducing weight, with significant improvements noted in several studies, particularly in five out of nine studies for physical activity and four out of five for weight loss.

While EAMS interventions appear feasible and have higher participant retention rates, their efficacy compared to other interventions remains unclear, highlighting the need for more high-quality randomized controlled trials to better understand their impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using an electronic activity monitor system as an intervention modality: A systematic review. Lewis, ZH., Lyons, EJ., Jarvis, JM., et al.[2022]

The IDEEA and SmartShoe activity monitors demonstrated high accuracy in identifying postures, with 97.4% and 94.2% accuracy, respectively, during various activities in a study involving ten healthy adult women.

The SmartShoe was particularly effective at detecting non-exercise movements like fidgeting while seated, outperforming the IDEEA in this aspect, which highlights its sensitivity to subtle physical activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of two novel monitoring devices to measure physical activity in healthy women. Klein, DA., Levine, E., Walsh, BT., et al.[2020]

The RT3 activity monitor was worn for an average of 14 hours daily by 21 healthy adults, with 90% of participants providing complete data sets, indicating good adherence and utility for measuring physical activity in free living conditions.

However, there was a 6.7% loss of activity data primarily due to battery malfunctions and non-adherence, highlighting the need for improved technical reliability and strategies to enhance participant compliance in long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of the RT3 triaxial accelerometer in free living: an investigation of adherence and data loss. Perry, MA., Hendrick, PA., Hale, L., et al.[2015]

In a study of 28 overweight/obese active duty soldiers over 6 months, using a web-linked accelerometer combined with mandatory physical training did not lead to significant weight loss or improvements in fitness outcomes compared to usual care.

Both groups showed minimal changes in weight and body fat, with no significant differences in blood pressure or heart rate, indicating that the accelerometer did not enhance the effectiveness of the physical training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an accelerometer on body weight and fitness in overweight and obese active duty soldiers. Shrestha, M., Combest, T., Fonda, SJ., et al.[2019]

A 12-week study involving 90 participants with type 2 diabetes found that both supervised exercise and technology-based programs (mobile app and smartwatch) led to similar improvements in glycemic control, measured by HbA1c levels.

Approximately 46% of participants in the supervised group and 43% in the technology groups achieved a clinically meaningful reduction in HbA1c, indicating that technology can be an effective alternative for diabetes management when supervised programs are not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technology-based and supervised exercise interventions for individuals with type 2 diabetes: Randomized controlled trial. Timurtas, E., Inceer, M., Mayo, N., et al.[2022]

A systematic review of 14 studies found a weak-to-moderate positive association between physical activity measured by wearable activity monitors (WAMs) and performance status (PS) in cancer patients, indicating that more activity may correlate with better performance.

Conversely, there was a weak-to-moderate negative association between sedentary behavior (SB) metrics from WAMs and PS, suggesting that less sedentary time could be linked to improved performance, but WAM data should not replace physician assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association between wearable activity monitor metrics and performance status in oncology: a systematic review. Kos, M., Pijnappel, EN., Buffart, LM., et al.[2022]

The Exercise is Medicine™ (EIM) approach was well-accepted by healthcare providers and fitness professionals, leading to adaptations in protocols for better integration into electronic health records.

In a pilot study with 36 participants, those who engaged in both EIM protocols and community physical activity programming (EIM+) experienced a significant increase in physical activity levels (+250 minutes/week) compared to those who only followed EIM protocols, who actually decreased their activity (-38.6 minutes/week).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise is Medicine™: A pilot study linking primary care with community physical activity support. Heath, GW., Kolade, VO., Haynes, JW.[2020]

In a study involving 220 low and moderate risk patients undergoing cardiac rehabilitation, a mobile health (mHealth) intervention did not significantly improve physical activity levels, as measured by the 6-minute walk distance, after 6 months compared to usual care.

While the mHealth intervention showed no overall benefit at 6 months, there were some indications of improved outcomes at 3 months for certain users, particularly those using Fitbit devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a mobile health intervention to augment cardiac rehabilitation. Golbus, JR., Gupta, K., Stevens, R., et al.[2023]

In a review of over 5,500 participants from 11 physical activity interventions, no serious study-related adverse events were reported, indicating a high level of safety in these exercise programs.

While minor musculoskeletal injuries were noted, the studies emphasized a 'start low and go slow' approach, suggesting that moderate-intensity physical activity is safe and effective for sedentary, chronically ill, or older populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. Ory, M., Resnick, B., Jordan, PJ., et al.[2022]

The Exercise is Medicine (EIM) initiative aims to make physical activity assessment and prescription a routine part of patient care, and a new evaluation framework has been developed to assess its implementation across health care systems.

Using the RE-AIM framework, the evaluation model focuses on key areas such as patient reach, effectiveness in improving health outcomes, adoption by health care settings, implementation by health care teams, and long-term maintenance of EIM practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pragmatic Application of the RE-AIM Framework for Evaluating the Implementation of Physical Activity as a Standard of Care in Health Systems. Stoutenberg, M., Galaviz, KI., Lobelo, F., et al.[2019]

A systematic review of 1,119 articles identified 27 studies that explored smartwatch applications in healthcare, focusing mainly on feasibility and usability rather than large-scale efficacy trials.

Most studies utilized Android-based smartwatches and targeted chronic disease self-management, indicating potential for monitoring conditions like seizures or gait disturbances, but more extensive research is needed to confirm their effectiveness in larger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A SURVEY OF SMARTWATCHES IN REMOTE HEALTH MONITORING. King, CE., Sarrafzadeh, M.[2020]

Sedentary behavior and physical inactivity are major risk factors for cardiovascular disease and overall mortality, highlighting the urgent need for increased physical activity across all demographics.

Improving cardiorespiratory fitness through exercise training is essential for preventing chronic diseases, particularly cardiovascular issues, and should be prioritized in healthcare strategies globally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sedentary Behavior, Exercise, and Cardiovascular Health. Lavie, CJ., Ozemek, C., Carbone, S., et al.[2019]

In a study involving 138 participants with diabetes or pre-diabetes, using a Fitbit with reminders and goal-setting did not lead to an overall increase in daily steps, as average daily steps decreased across all groups.

However, setting personal step goals was associated with a significant increase of 791 daily steps on those days, indicating that while the overall intervention was not effective, goal-setting can temporarily boost activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of automated text messaging and goal setting on pedometer adherence and physical activity in patients with diabetes: A randomized controlled trial. Polgreen, LA., Anthony, C., Carr, L., et al.[2020]

Participants in the primary intervention group maintained higher levels of moderate to vigorous physical activity (MVPA) 12 weeks after the intervention, although their sitting time slightly increased, indicating some sustainability of activity levels.

The waitlist control group, after receiving only the Garmin Vivofit 2 activity tracker, showed a significant increase in MVPA and a reduction in sedentary behavior, suggesting that wearable technology alone can effectively promote physical activity changes in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of physical activity and sedentary behavior change, and physical activity and sedentary behavior change after an abridged intervention: Secondary outcomes from the ACTIVATE Trial. Lynch, BM., Nguyen, NH., Moore, MM., et al.[2020]

Citations

1. withpower.com withpower.com/trial/phase-physical-inactivity-2-2024-194a0?condition=&query=Reduced+Physical+Activity&overallStatus=Recruiting&hasNoPlacebo=false

Smartwatches for Sedentary Lifestyle (EIM+ Trial) The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03416634

Exercise is Medicine at Emory Seavey Internal ... This wearable device tracks daily activity and gives reminders to move after an hour of inactivity. The battery lasts for one year and the device is water ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4721379/

Exercise is Medicine™: A pilot study linking primary care ... EIM + patients had fewer bad physical health days compared with EIM patients. Introduction. Regular physical activity (PA) is associated with enhanced health ...

4. exerciseismedicine.org exerciseismedicine.org/eim-results/

EIM Results EIM has created a quarterly Scorecard that summarizes its impact across the three main stakeholder groups: Healthcare Providers, Exercise Professionals ... and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25001155

Wearable Devices for Exercise Prescription and Physical ... These results highlight that exercise programs incorporating wrist-worn wearables may lead to increased step counts and improvement in symptoms, physical ...

6. exerciseismedicine.org exerciseismedicine.org/partner-with-eim/industry-partners/eim-and-exi/

EIM and EXI - Exercise is Medicine EXI offers a co-branded app that automates personalized exercise programs to address chronic conditions and sedentary lifestyles. Our approach combines the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7444006/

Exercise Is Medicine - PMC - PubMed Central - NIH Exercise is Medicine is a solution that enables physicians to support their patients in implementing exercise as part of their disease prevention and treatment ...

8. exerciseismedicine.org exerciseismedicine.org/eim-research0/physical-activity-health-impact/

Physical Activity: Health Impact This report summarizes the scientific evidence on physical activity and health and was used to develop the second edition of the Physical Activity Guidelines ...