Tai Chi + Wearable Tracker for Heart Attack Recovery (Mind2Move Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Beth Israel Deaconess Medical Center
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This projects studies the role of tai chi exercise and wearable fitness trackers to promote physical activity in acute coronary syndrome (ACS) survivors.
Is Tai Chi combined with a wearable tracker a promising treatment for heart attack recovery?Yes, Tai Chi combined with a wearable tracker is a promising treatment for heart attack recovery. Wearable trackers like Fitbit can help monitor and encourage physical activity, which is important for heart health. Studies show that these devices can motivate people to be more active, which is beneficial for recovery after a heart attack. Tai Chi, a gentle form of exercise, can also improve physical health and well-being, making this combination a valuable approach for recovery.13468
What safety data exists for Tai Chi and wearable trackers in heart attack recovery?The provided research does not directly address safety data for Tai Chi and wearable trackers in heart attack recovery. However, it discusses the use of wearable trackers like Fitbit in various contexts, including their validity, reliability, and challenges in research settings. The studies focus on the effectiveness of wearables in promoting physical activity and adherence to exercise, but they do not specifically mention safety data related to heart attack recovery or Tai Chi.1591011
What data supports the idea that Tai Chi + Wearable Tracker for Heart Attack Recovery is an effective treatment?The available research shows that wearable activity trackers, like Fitbit, can help increase physical activity, which is beneficial for heart health. However, the research specifically on heart attack recovery is limited. One study suggests that these devices are not very accurate in measuring steps and distance in post-cardiac surgery patients, which might affect their usefulness in tracking recovery progress. Overall, while wearables can encourage more activity, their effectiveness in heart attack recovery compared to other treatments isn't clearly supported by the data provided.12378
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your healthcare provider for guidance.
Eligibility Criteria
This trial is for adults over 18 who've had an acute coronary syndrome (like a heart attack) and live a sedentary lifestyle, exercising less than 150 minutes per week. They need internet access, an email account they check weekly, and their doctor's okay to do low-to-moderate intensity exercise like tai chi.Inclusion Criteria
I am 18 years old or older.
I have had a type of heart attack or unstable chest pain.
Exclusion Criteria
I do not have untreated heart rhythm problems.
I do not have severe heart problems like chest pain or difficulty breathing at rest.
I do not have severe memory or thinking problems.
I have bone or joint problems that prevent me from practicing Tai Chi.
My heart condition severely limits my physical activity.
I have severe depression that hasn't been treated.
Participant Groups
The study looks at how tai chi exercises combined with the use of a wearable fitness tracker might help people who have survived acute coronary syndrome become more physically active.
2Treatment groups
Experimental Treatment
Active Control
Group I: Tai chi + wearableExperimental Treatment1 Intervention
48 virtual tai chi classes on Zoom over 6 months plus assigned home practice of tai chi 3x a week plus daily use of a Fitbit fitness tracker will be required for this group.
Group II: Enhanced usual careActive Control1 Intervention
Printed educational materials based on existing resources (e.g., AHA; Centers for Disease Control and Prevention) will be shared with subjects in this group.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Beth Israel Deaconess Medical CenterBoston, MA
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
LifespanCollaborator
References
Systematic review of the validity and reliability of consumer-wearable activity trackers. [2022]Consumer-wearable activity trackers are electronic devices used for monitoring fitness- and other health-related metrics. The purpose of this systematic review was to summarize the evidence for validity and reliability of popular consumer-wearable activity trackers (Fitbit and Jawbone) and their ability to estimate steps, distance, physical activity, energy expenditure, and sleep.
Utility of Consumer Physical Activity Trackers as an Intervention Tool in Cardiovascular Disease Prevention and Treatment. [2018]Consumer activity trackers have grown in popularity over the last few years. These devices are typically worn on the hip or wrist and provide the user with information about physical activity measures such as steps taken, energy expenditure, and time spent in moderate to vigorous physical activity. The consumer may also use the computer interface (e.g. device websites, smartphone applications) to monitor and track achievement of PA goals and compete with other users. This review will describe some of the most popular consumer devices and discuss the user feedback tools. We will also present the limited evidence available about the accuracy of these devices and highlight how they have been used in cardiovascular disease management. We conclude with some recommendations for future research, focusing on how consumer devices might be used to assess effectiveness of various cardiovascular treatments.
The utility of personal activity trackers (Fitbit Charge 2) on exercise capacity in patients post acute coronary syndrome [UP-STEP ACS Trial]: a randomised controlled trial protocol. [2022]The benefits of physical activity and cardiovascular rehabilitation on the reduction of cardiovascular risk are well documented. Despite this, significant barriers and challenges remain in optimizing patient risk factors post acute coronary syndromes (ACS) and ensuring patient compliance. Consumer wearable personal activity trackers represent a cost effective and readily available technology that may aid in this endeavour.
Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. [2020]Although designed as a consumer product to help motivate individuals to be physically active, Fitbit activity trackers are becoming increasingly popular as measurement tools in physical activity and health promotion research and are also commonly used to inform health care decisions.
MOVE-HF: an internet-based pilot study to improve adherence to exercise in patients with heart failure. [2020]The use of the internet and newer activity monitors such as the Fitbit Charge HR to improve exercise adherence is limited. The primary aim of the Move on Virtual Engagement (MOVE-HF) was to investigate the effects of group social support by internet-based synchronized face-to-face video and objective physical activity feedback on adherence to recommended exercise guidelines.
Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. [2022]This study examined the use of activity trackers alone or combined with weekly communication through email to improve activity and body composition over one academic year in medical students. This randomized clinical trial conducted at the New York Institute of Technology from July 7, 2016 through June 4, 2017 enrolled 120 medical students. The first group (Fitbit-Plus) wore activity trackers and received weekly emails offering fitness challenges and lifestyle modification challenges. The second group (Fitbit-Only) received only activity trackers and did not receive weekly emails. The third group (Control) was asked not to purchase an activity tracker of any kind throughout the study. All groups had a body composition analysis prior to the start of the academic year and at the end of the first academic year. Outcome measures included step count and body composition (body fat percentage and lean body mass). The results showed the overall mean daily steps were greater in the Fitbit-Plus group than the Fitbit-Only group for the academic year (7429 ± 2833 vs. 6483 ± 2359) with only months April and May showing a significant difference between the groups (p = 0.011; p = 0.044). Body fat percentage decreased in the Fitbit-Plus overweight women (2.1 ± 1.6%) lean body mass increased in the Fitbit-Plus group in overweight men (2.4 ± 4.6 lbs.). A subsequent finding of this study showed improved body composition in a small sub-group of over-weight students. Weekly behavioral challenges combined with an activity tracker increased step count in medical students compared to an activity tracker alone. Clinicaltrials.gov Identifier: NCT02778009.
Validation of the Fitbit Flex in an Acute Post-Cardiac Surgery Patient Population. [2020]Purpose: This study examined the validity of the Fitbit Flex activity monitor for step count and distance walked among post-cardiac surgery patients. Method: Participants (n=20) from a major urban cardiac surgery centre were recruited 1-2 days before hospital discharge. The Fitbit Flex step count and distance walked outputs and video recording of each participant performing the 6-minute walk test were collected. Fitbit Flex output was compared with criterion measures of manual step count obtained from the video recording and manual measurement of distance walked. Statistical analysis compared the output and criterion measures using paired sample t-tests, Pearson correlation coefficients, Lin's concordance correlations, and Bland-Altman plots. Sub-analysis compared slower walking (<0.8 m/s; n=11) and faster walking (≥0.8 m/s; n=8) group speeds (1 participant was excluded from analysis). Results: Steps counted and distance walked were significantly different between the Fitbit Flex outputs and criterion measures (p<0.05). The Fitbit Flex steps counted and distance walked showed moderate association with manual measure steps counted (r=0.67) and distance walked (r=0.45). Lin's concordance coefficients revealed a lack of agreement between the Fitbit Flex and the criterion measurement of both steps counted (concordance correlation coefficient [CCC]=0.43) and distance walked (CCC=0.36). The percentage of relative error was -18.6 (SD 22.7) for steps counted and 25.4 (SD 45.8) for distance walked. Conclusions: The Fitbit Flex activity monitor was not a valid measure of step count and distance walked in this sample of post-cardiac surgery patients. The lack of agreement between outputs and criterion measures suggests the Fitbit Flex alone would not be an acceptable clinical outcome measure for monitoring walking progression in the early postoperative period.
Use of consumer wearable devices to promote physical activity among breast, prostate, and colorectal cancer survivors: a review of health intervention studies. [2020]A growing amount of research has successfully incorporated Fitbit devices and other wearable activity trackers into technology-oriented lifestyle interventions to increase physical activity among cancer survivors.
Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. [2020]Lack of physical activity (PA) is a risk factor for death and non-communicable disease. Despite this, more than one fourth of adults worldwide do not follow PA guidelines. As part of a feasibility study to test a complex intervention for increasing PA, we included a consumer-based activity tracker (AT) as a tool to measure PA outcomes and to track heart rate during exercise sessions. The aim of the present study was to identify factors that increase wear time when using a consumer-based AT for monitoring of participants in clinical research.
Using Fitbit as an mHealth Intervention Tool to Promote Physical Activity: Potential Challenges and Solutions. [2021]Consumer-based physical activity (PA) trackers, also known as wearables, are increasingly being used in research studies as intervention or measurement tools. One of the most popular and widely used brands of PA trackers is Fitbit. Since the release of the first Fitbit in 2009, hundreds of experimental studies have used Fitbit devices to facilitate PA self-monitoring and behavior change via goal setting and feedback tools. Fitbit's ability to capture large volumes of PA and physiological data in real time creates enormous opportunities for researchers. At the same time, however, it introduces a number of challenges (eg, technological, operational, logistical), most of which are not sufficiently described in study publications. Currently, there are no technical reports, guidelines, nor other types of publications discussing some of these challenges and offering guidance to researchers on how to best incorporate Fitbit devices in their study design and intervention to achieve their research goals. As a result, researchers are often left alone to discover and address some of these issues during the study through "trial and error." This paper aims to address this gap. Drawing on our cumulative experience of conducting multiple studies with various Fitbit PA trackers over the years, we present and discuss various key challenges associated with the use of Fitbit PA trackers in research studies. Difficulties with the use of Fitbit PA trackers are encountered throughout the entire research process. Challenges and solutions are categorized in 4 main categories: study preparation, intervention delivery, data collection and analysis, and study closeout. Subsequently, we describe a number of empirically tested strategies used in 4 of our interventional studies involving participants from a broad range of demographic characteristics, racial/ethnic backgrounds, and literacy levels. Researchers should be prepared to address challenges and issues in a timely fashion to ensure that the Fitbit effectively assists participants and researchers in achieving research and outcome goals.
A randomized trial to promote physical activity in adult pre-hypertensive and hypertensive patients. [2022]The purpose of the pilot study was to determine the effectiveness of wearable activity trackers alone or in combination with behaviour change strategies for promoting physical activity (PA) among individuals with pre-hypertension or hypertension. A sample of 44 adults (68% female and mean age 55) were randomized to receive either a Fitbit Charge HR 3 alone (FB) or the Fitbit in combination with behaviour change strategies (i.e., goal setting, behaviour goal review, adaptive feedback) delivered by a trained health coach (FB+) for 12 weeks. Moderate and vigorous PA (MVPA), steps, and sedentary time (ST) were assessed using ActiGraph wGT3X-BT. The FB+ group significantly increased PA [+1854 (2518) steps/day, p