150 Participants Needed

Smartwatches for Sedentary Lifestyle

(EIM+ Trial)

LR
TC
Overseen ByToluwa C Nafiu, B.S.
Age: 65+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The effects of exercise on prevention and improved control of chronic diseases, reduced mortality, and improved quality of life are well established. Exercise has been shown to prevent heart disease, stroke, type 2 diabetes, depression, and certain types of cancers. In addition to prevention, physical activity is included in the standard or care for many chronic diseases and used in treatment. For example, the American Diabetes Association has identified positive health behaviors like physical activity as foundational in the treatment and management of disease and improving overall quality of life. The Ohio State University Wexner Medical Center Exercise is Medicine Program (EIM) is a physician referral program that aims to increase physical activity to prevent and reduce complications from chronic disease. The integration of technology among a 65+ population of EIM participants provides a novel approach to improving individual's health. Thus, our study aims to provide EIM participants aged 65+ with smartwatches in the hopes of increasing their overall physical activity levels.

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 data supports the effectiveness of the treatment EIM+, Exercise is Medicine Program with Smartwatches for a sedentary lifestyle?

Research shows that using smartwatches and mobile health interventions can help people increase their physical activity levels, as seen in studies with cardiac rehabilitation and type 2 diabetes patients. These devices can provide feedback and motivation, which may help reduce sedentary behavior.12345

Is the use of smartwatches for promoting physical activity generally safe?

Research on physical activity interventions, including those using smartwatches, shows that while minor injuries like muscle strains can occur, no serious safety issues have been reported. It's important to start with low-intensity activities and gradually increase to avoid injuries.36789

How is the EIM+ treatment different from other treatments for a sedentary lifestyle?

The EIM+ treatment is unique because it combines the Exercise is Medicine program, which integrates physical activity into standard patient care, with the use of smartwatches to monitor and encourage activity. This approach leverages technology to provide real-time feedback and support, making it different from traditional methods that may not use such interactive tools.1011121314

Research Team

JJ

Joshua Joseph, MD

Principal Investigator

Ohio State University

Eligibility Criteria

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
See 13 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Exercise is Medicine PlusExperimental Treatment1 Intervention
Participants receiving the Exercise is Medicine program along with a smartwatch.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials
891
Recruited
2,659,000+

Findings from Research

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

References

A randomized trial of a mobile health intervention to augment cardiac rehabilitation. [2023]
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. [2020]
Utility of the RT3 triaxial accelerometer in free living: an investigation of adherence and data loss. [2015]
Technology-based and supervised exercise interventions for individuals with type 2 diabetes: Randomized controlled trial. [2022]
The association between wearable activity monitor metrics and performance status in oncology: a systematic review. [2022]
Screening, safety, and adverse events in physical activity interventions: collaborative experiences from the behavior change consortium. [2022]
Validation of two novel monitoring devices to measure physical activity in healthy women. [2020]
Effect of an accelerometer on body weight and fitness in overweight and obese active duty soldiers. [2019]
Using an electronic activity monitor system as an intervention modality: A systematic review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Exercise is Medicine™: A pilot study linking primary care with community physical activity support. [2020]
11.United Statespubmed.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. [2019]
A SURVEY OF SMARTWATCHES IN REMOTE HEALTH MONITORING. [2020]
13.United Statespubmed.ncbi.nlm.nih.gov
Sedentary Behavior, Exercise, and Cardiovascular Health. [2019]
14.United Statespubmed.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. [2020]
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