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

Trial Summary

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 data supports the effectiveness of this treatment for heart attack recovery?

Research shows that wearable fitness trackers like Fitbit can help increase physical activity, which is beneficial for heart health. These devices have been used successfully in lifestyle interventions for cancer survivors and in managing cardiovascular disease, suggesting they may support heart attack recovery by encouraging more exercise. ^{1 2 3 4 5}

Is it safe to use Tai Chi and wearable fitness trackers for heart attack recovery?

Wearable fitness trackers like Fitbit have been widely used in research studies to monitor physical activity and promote exercise, and they are generally considered safe for use in humans. Tai Chi is a gentle form of exercise that is also generally safe and has been used for various health conditions, including heart health. ^{3 6 7 8 9}

How is the Tai Chi + Wearable Tracker treatment unique for heart attack recovery?

This treatment is unique because it combines Tai Chi, a gentle form of exercise known for improving balance and reducing stress, with a wearable fitness tracker like Fitbit, which helps monitor physical activity and encourage consistent exercise. This combination aims to enhance recovery by promoting physical activity and providing real-time feedback, which is different from traditional heart attack recovery methods that may not include such interactive and personalized components. ^{1 2 3 10 11}

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.

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

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

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

Access to a digital device with internet connection

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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-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]

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]

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]

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]

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]

References

1. United States 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. [2020]

2. England 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Systematic review of the validity and reliability of consumer-wearable activity trackers. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. Canada pubmed.ncbi.nlm.nih.gov

Validation of the Fitbit Flex in an Acute Post-Cardiac Surgery Patient Population. [2020]

6. England pubmed.ncbi.nlm.nih.gov

MOVE-HF: an internet-based pilot study to improve adherence to exercise in patients with heart failure. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Succeeding with prolonged usage of consumer-based activity trackers in clinical studies: a mixed methods approach. [2020]

8. Canada pubmed.ncbi.nlm.nih.gov

Using Fitbit as an mHealth Intervention Tool to Promote Physical Activity: Potential Challenges and Solutions. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A randomized trial to promote physical activity in adult pre-hypertensive and hypertensive patients. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Accuracy of Fitbit Devices: Systematic Review and Narrative Syntheses of Quantitative Data. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Utilizing wearable technology to increase physical activity in future physicians: A randomized trial. [2022]