Tai Chi + Wearable Tracker for Heart Attack Recovery

(Mind2Move Trial)

Overseen By Daniel Litrownik, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Beth Israel Deaconess Medical Center

Disqualifiers: Hypertension, Arrhythmias, Depression, 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: 50

Duration: 6 months

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how tai chi and wearable fitness trackers can increase activity levels in individuals who have experienced a heart attack (acute coronary syndrome). One group of participants will attend virtual tai chi classes and use a Fitbit, while another group will receive educational materials. The trial seeks individuals who have had a heart attack, are currently inactive, and have internet access. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.

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's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that tai chi and wearable fitness trackers are safe for heart attack recovery?

Research has shown that tai chi is safe for people with heart conditions. In one study, a six-month tai chi program helped participants become more active, lose weight, and feel better overall, without any harm. Another study found that people with chronic heart failure could practice tai chi without problems, suggesting it could complement traditional heart recovery exercises.

For wearable fitness trackers, studies have shown they help people with heart conditions become more active and improve their exercise ability, without major issues. These devices collect important information about heart activity, aiding in safely monitoring heart health.

Together, tai chi and wearable trackers have been shown to be safe for heart patients in studies. This trial focuses on combining them, building on that foundation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Tai Chi + Wearable Tracker treatment for heart attack recovery because it combines the mind-body benefits of Tai Chi with the real-time feedback of a fitness tracker. Unlike traditional cardiac rehab programs that focus on structured exercise routines, this approach encourages gentle movement and mindfulness, which can be more accessible to patients. Additionally, the use of a Fitbit provides continuous monitoring and motivation, helping patients stay engaged with their recovery. This combination aims to improve both physical and mental well-being, potentially offering a more holistic recovery option.

What evidence suggests that tai chi and a wearable tracker could be effective for heart attack recovery?

Research has shown that tai chi can improve heart health in individuals who have experienced a heart attack. It enhances heart function, boosts exercise capacity, and reduces anxiety and depression in heart patients. One study found that a six-month tai chi program improved physical activity and quality of life more than shorter programs.

In this trial, one group will participate in tai chi classes and use a wearable fitness tracker. Wearable fitness trackers can benefit heart health by encouraging more physical activity and improving exercise ability. These devices help individuals stay active by monitoring steps, heart rate, and other health indicators. Combining tai chi with wearables might effectively support recovery after a heart attack. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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

Absence of contraindications to physical exercise per the participant's provider evaluation

Access to a digital device with internet connection

Having an active email account and ability to check email at least weekly

Exclusion Criteria

Medical conditions likely to limit lifespan to less than one year

I do not have untreated heart rhythm problems.

I practice mind-body activities like meditation, Tai Chi, or yoga weekly.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 6-month group tai chi program with wearable feedback technology, including 48 virtual classes and home practice

6 months

48 virtual classes, daily Fitbit use

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 6 and 9 months

3 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tai chi + wearable

Trial Overview

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.

How Is the Trial Designed?

Group I: Tai chi + wearable Experimental Treatment 1 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 care Active Control 1 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.

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Lifespan

Collaborator

Trials

43

Recruited

41,100+

Published Research Related to This Trial

Cancer survivors using wearable activity trackers, like Fitbits, have shown an increase in physical activity, which is important for reducing negative effects from cancer treatments and improving overall health outcomes.

The review identified 13 relevant studies, including 8 randomized controlled trials, indicating a need for further research to better understand how these devices can effectively promote physical activity and weight management in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of consumer wearable devices to promote physical activity among breast, prostate, and colorectal cancer survivors: a review of health intervention studies. Coughlin, SS., Caplan, LS., Stone, R.[2020]

The MOVE-HF study involved 30 stable heart failure patients and aimed to assess the impact of internet-based social support and physical activity feedback on exercise adherence, finding that participants valued the motivational feedback from their Fitbit devices.

While the experimental group reported feeling social support through weekly video sessions, the overall exercise adherence rates were similar between the experimental and comparison groups, indicating that more research is needed to determine the effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MOVE-HF: an internet-based pilot study to improve adherence to exercise in patients with heart failure. Deka, P., Pozehl, B., Williams, MA., et al.[2020]

In a 12-month feasibility study involving 16 participants aged 55-74 with obesity and elevated cardiovascular risk, the use of a Polar M430 activity tracker showed high adherence, with an average of 292 valid wear days (80% of the study duration).

Participants reported that the tracker helped them monitor their physical activity and heart rate, but issues like measurement inaccuracies and design preferences affected their experience, suggesting that better instructions and more appealing designs could enhance wear time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. Henriksen, A., Sand, AS., Deraas, T., et al.[2020]

Fitbit devices are widely used in research to monitor physical activity and promote behavior change, but researchers face significant challenges in their implementation, including technological and logistical issues.

This paper outlines key challenges encountered during the research process with Fitbit trackers and provides empirically tested strategies to help researchers effectively integrate these devices into their studies, ensuring better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Fitbit as an mHealth Intervention Tool to Promote Physical Activity: Potential Challenges and Solutions. Balbim, GM., Marques, IG., Marquez, DX., et al.[2021]

In a pilot study of 44 adults with pre-hypertension or hypertension, using a Fitbit alone increased moderate and vigorous physical activity (MVPA) and reduced sedentary time, but combining it with behavior change strategies led to even greater improvements.

Participants using the Fitbit with behavior change support increased their MVPA by an average of 26 minutes per day compared to just 11 minutes for those using the Fitbit alone, highlighting the added benefit of coaching in promoting physical activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to promote physical activity in adult pre-hypertensive and hypertensive patients. Bai, Y., Burns, R., Gell, N., et al.[2022]

Consumer-wearable activity trackers like Fitbit and Jawbone show high validity in counting steps, with laboratory studies reporting strong correlations (CC > 0.80) between tracker-assessed and actual steps.

However, these trackers tend to underestimate energy expenditure and overestimate sleep metrics when compared to more accurate methods like polysomnography, indicating that while they are reliable for step counting, their accuracy for other health metrics may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of the validity and reliability of consumer-wearable activity trackers. Evenson, KR., Goto, MM., Furberg, RD.[2022]

The UP-STEP ACS trial is a randomized control study involving 200 patients recovering from acute coronary syndromes, aiming to evaluate the effectiveness of personal activity trackers on improving exercise capacity, measured by the six-minute walk test (6MWT).

If successful, the study could demonstrate that personal activity trackers are a cost-effective and accessible tool to enhance exercise capacity and potentially reduce cardiovascular risks in patients after acute coronary syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Nogic, J., Thein, PM., Cameron, J., et al.[2022]

Consumer activity trackers, which monitor physical activity metrics like steps and energy expenditure, have become increasingly popular and may aid users in achieving their physical activity goals.

Current evidence on the accuracy of these devices is limited, but they show potential for use in managing cardiovascular disease, suggesting a need for further research to evaluate their effectiveness in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Consumer Physical Activity Trackers as an Intervention Tool in Cardiovascular Disease Prevention and Treatment. Hickey, AM., Freedson, PS.[2018]

Fitbit activity trackers show acceptable accuracy for step counting about half the time, often underestimating steps in controlled settings and overestimating in free-living environments, particularly when used by adults without mobility limitations.

The devices are generally unreliable for measuring energy expenditure and may inaccurately estimate time spent in higher-intensity activities and distance during faster walking, suggesting caution in their use for health research and decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. Feehan, LM., Geldman, J., Sayre, EC., et al.[2020]

Medical students using activity trackers combined with weekly email communication (Fitbit-Plus group) significantly increased their daily step count compared to those using only the trackers (Fitbit-Only group), with an average of 7429 steps versus 6483 steps over the academic year.

The Fitbit-Plus group also showed improvements in body composition, with overweight women experiencing a decrease in body fat percentage and overweight men gaining lean body mass, highlighting the effectiveness of combining behavioral challenges with activity tracking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. DiFrancisco-Donoghue, J., Jung, MK., Stangle, A., et al.[2022]

The Fitbit Flex activity monitor was found to be an invalid measure of step count and distance walked in post-cardiac surgery patients, based on a study involving 20 participants.

There was a significant discrepancy between the Fitbit outputs and manual measurements, indicating that the device should not be used as a clinical tool for monitoring walking progression in the early postoperative period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Validation of the Fitbit Flex in an Acute Post-Cardiac Surgery Patient Population. Daligadu, J., Pollock, CL., Carlaw, K., et al.[2020]

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