Mobile Health Exercise Program for Fall Risk Prevention in Cardiac Patients

Recruiting at 1 trial location

Overseen By Robert Scales, PhD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Advanced dementia, Wheelchair bound, Vision loss, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 to 14 weeks

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a home-based exercise program can help heart patients improve balance, muscle strength, and quality of life. Participants are divided into two groups: one receives standard cardiac rehab, while the other adds extra balance and muscle training through a mobile health app. Individuals who recently began cardiac rehab and can use a smartphone may be suitable for this trial. As an unphased study, this trial provides a unique opportunity to explore innovative methods to enhance cardiac rehabilitation.

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 to focus on exercise and balance training, so it's best to check with the trial organizers or your doctor.

What prior data suggests that this mobile health exercise program is safe for cardiac patients?

A previous study showed that mobile health (mHealth) technologies can reduce falls among older adults. Research indicates that these technologies, such as apps and devices, help people manage their health and prevent injuries. Although most studies remain in the early stages, they have not reported any major safety issues, suggesting that mHealth-based exercise programs are generally safe and well-tolerated.

The exercise program in this trial uses mHealth to improve balance and muscle strength. Since this approach has been used without significant problems, it is likely safe for participants. However, as with any exercise program, participants should follow the instructions and report any unusual symptoms to a doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to prevent falls in cardiac patients through a mobile health exercise program. Unlike traditional cardiac rehabilitation, which often involves in-person sessions at a medical facility, this program offers home-based training delivered via mobile health technology. This approach could make it easier for patients to stick to their exercise routines by providing flexibility and convenience. Additionally, the trial includes a focus on balance and muscle strength training, which is not typically emphasized in standard cardiac rehab programs. These innovations could improve patient outcomes by reducing fall risk, which is a significant concern for cardiac patients.

What evidence suggests that this trial's treatments could be effective for fall risk prevention in cardiac patients?

Research has shown that mobile health (mHealth) tools can help lower the risk of falls in older adults. In this trial, participants in the intervention group will receive additional balance and muscle strength training through a home-based, mHealth-delivered physical function training program. One study found that heart health exercises at home with mHealth improved the walking distance of patients with heart disease. Another study showed that online home exercise programs can boost muscle strength and overall function. These findings suggest that a structured exercise plan at home, focusing on balance and strength, might help heart patients perform daily tasks better and feel more confident in their balance. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert Scales, PhD, MS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients starting outpatient cardiac rehabilitation (CR) who can use a smart mobile device. It's not suitable for those in wheelchairs, with recent sternotomy, advanced dementia, or significant vision loss.

Inclusion Criteria

I am undergoing early outpatient cardiac rehabilitation.

All participants must have access to a smart mobile device

Exclusion Criteria

I had chest surgery less than 12 weeks ago.

I use a wheelchair for mobility.

My condition is advanced dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a structured exercise plan designed to improve balance and muscle strength, which can be done at home

7 to 14 weeks

Follow-up

Participants are monitored for changes in balance confidence, physical function, fall risk, and health-related quality of life

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cardiac Rehabilitation & Exercise Prescription
• Connected mHealth mobile application
• Home-based, m-Health Delivered Physical Function Training

Trial Overview The study tests if a home-based exercise program delivered via an mHealth app improves physical function, balance confidence, and quality of life in cardiac rehab patients compared to standard care.

How Is the Trial Designed?

Group I: Intervention group of additional balance and muscle strength training Experimental Treatment 3 Interventions

Group II: Control group of cardiac rehabilitation only Active Control 2 Interventions

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A randomized controlled trial involving 170 adults with cardiovascular disease is testing a mobile phone-delivered exercise-based cardiac rehabilitation program to improve exercise capacity and functional outcomes compared to usual care.

The trial aims to assess not only the effectiveness of the mHealth program in increasing exercise behavior over six months but also its impact on cardiovascular risk factors and overall quality of life, potentially offering a scalable solution for cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HEART: heart exercise and remote technologies: a randomized controlled trial study protocol. Maddison, R., Whittaker, R., Stewart, R., et al.[2021]

A randomized controlled trial involving 160 post-acute coronary syndrome patients showed that mobile health augmented cardiac rehabilitation (MCard) significantly improved health-related quality of life (HRQoL) scores, including physical and mental health components, at both 12 and 24 weeks compared to standard care.

All domains of the MacNew quality of life myocardial infarction tool (social, emotional, physical, and global) also showed significant improvement in the MCard group, indicating that this intervention can enhance overall patient well-being after cardiac events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Health Augmented Cardiac Rehabilitation (MCard) on health-related quality of life among post-acute coronary syndrome patients: A randomized controlled trial. Hisam, A., Haq, ZU., Aziz, S., et al.[2022]

Mobile technologies, including wearable activity monitors and virtual rehabilitation solutions, have the potential to enhance adherence to cardiac rehabilitation, which is crucial for improving quality of life and reducing hospitalizations.

The review of 113 studies showed mixed results regarding the efficacy of virtual cardiac rehabilitation compared to traditional methods, but highlighted the importance of user adherence and long-term engagement as key benefits of these technologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual healthcare solutions for cardiac rehabilitation: a literature review. Lee, KCS., Breznen, B., Ukhova, A., et al.[2023]

The mobile health augmented cardiac rehabilitation (MCard) program significantly improved physical activity and healthy eating behaviors among post-acute coronary syndrome patients over a six-month period, with notable increases in healthy eating scores and reduced salt intake.

MCard was shown to be a feasible intervention that led to lasting behavior modifications in patients, although it did not significantly affect medication compliance, smoking behavior, or self-monitoring of blood pressure and weight.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mobile Health Augmented Cardiac Rehabilitation on Behavioural Outcomes among Post-acute Coronary Syndrome Patients: A Randomised Controlled Trial. Manzoor, S., Hisam, A., Aziz, S., et al.[2021]

A study involving 196 patients who underwent coronary artery bypass graft surgery found that home-based exercise training during cardiac rehabilitation led to better long-term exercise capacity and physical activity levels compared to hospital-based training, even six years after the program.

At the six-year follow-up, patients who trained at home had a higher peak oxygen uptake (1506 ml/min) and better physical activity scores compared to those who trained in the hospital, indicating that home-based rehabilitation may offer superior benefits for maintaining fitness and activity levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Six-year follow-up of a randomised controlled trial examining hospital versus home-based exercise training after coronary artery bypass graft surgery. Smith, KM., McKelvie, RS., Thorpe, KE., et al.[2022]

Cardiac rehabilitation (CR) in Brazilian coronary patients led to significantly lower rates of hospitalizations and nonfatal heart events compared to a wait-list control group, indicating its efficacy in reducing morbidity.

Participants in CR maintained their functional capacity, risk factor control, and heart-health knowledge over a year, with comprehensive CR showing significantly greater knowledge retention than exercise-only CR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Maintenance of Gains, Morbidity, and Mortality at 1 Year Following Cardiac Rehabilitation in a Middle-Income Country: A Wait-List Control Crossover Trial. Chaves, GSS., Lima de Melo Ghisi, G., Britto, RR., et al.[2021]

A smartphone-enabled, home-based cardiac rehabilitation program was found to be feasible for veterans with coronary heart disease, with 13 out of 18 participants completing the full 12-week intervention.

Participants showed significant improvements in functional capacity and systolic blood pressure, indicating that this approach can effectively enhance health outcomes while maintaining high levels of patient satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Smartphone-enabled Cardiac Rehabilitation Program in Male Veterans With Previous Clinical Evidence of Coronary Heart Disease. Harzand, A., Witbrodt, B., Davis-Watts, ML., et al.[2023]

The study will evaluate the effectiveness of a mobile health augmented cardiac rehabilitation program (MCard) over 23-24 weeks for improving health-related quality of life (HRQoL) and clinical outcomes in 160 post-acute coronary syndrome (ACS) patients.

If successful, MCard could provide a cost-effective and resource-efficient rehabilitation option that can be scaled to other cardiac centers, especially important during the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Augmented Cardiac Rehabilitation (MCard) in Post-Acute Coronary Syndrome Patients: A randomised controlled trial protocol. Hisam, A., Haq, ZU., Khan, Z., et al.[2022]

A pilot study involving 60 patients showed that using the Movn mobile app and a Fitbit significantly increased daily step counts in cardiac rehabilitation patients, with the intervention group averaging 8860 steps compared to 6633 in the control group.

Despite the increase in physical activity, there were no significant differences between the intervention and control groups in terms of functional capacity (measured by the 6-minute walk test), depression levels, or self-efficacy for maintaining exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Intervention Promoting Physical Activity in Adults Post Cardiac Rehabilitation: Pilot Randomized Controlled Trial. Park, LG., Elnaggar, A., Lee, SJ., et al.[2021]

This study will evaluate the effectiveness of a mobile health (mHealth) application in enhancing physical activity levels among 132 coronary artery disease patients over an 18-week randomized controlled trial, comparing various training combinations.

The primary goal is to measure changes in habitual physical activity, while secondary outcomes will assess improvements in fitness, quality of life, and cardiovascular risk, providing insights into the long-term benefits of integrating mHealth into cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of a personalised mHealth home-based training application on physical activity levels during and after centre-based cardiac rehabilitation: rationale and design of the Cardiac RehApp randomised control trial. Vonk, T., Bakker, EA., Zegers, ES., et al.[2021]

A home-based cardiac rehabilitation program significantly improved cardiovascular function in low-risk patients, with the home group showing increased peak VO2 and exercise capacity after three months, while the control group experienced a decline.

The program was not only effective but also cost-efficient, averaging $502.71 per patient, and achieved 100% adherence, indicating high patient engagement and potential for widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How much do the benefits cost? Effects of a home-based training programme on cardiovascular fitness, quality of life, programme cost and adherence for patients with coronary disease. Salvetti, XM., Oliveira, JA., Servantes, DM., et al.[2008]

Mobile health (mHealth) interventions for cardiac rehabilitation (CR) and heart failure management have shown high participant engagement and adherence, making them a feasible alternative to traditional center-based programs.

mHealth delivery of CR is as effective as traditional methods, leading to significant improvements in quality of life, although the impact on hospital utilization for heart failure patients was inconsistent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphones in the secondary prevention of cardiovascular disease: a systematic review. Hamilton, SJ., Mills, B., Birch, EM., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05826587

Cardiac Rehabilitation Mobile-Health Fall Risk Prevention ... The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11985854/

Mobile health (mHealth) technologies for fall prevention ... Abstract. Introduction. mHealth technologies offer promising solutions to reduce the incidence of falls among older adults.

3. thelancet.com thelancet.com/journals/landig/article/PIIS2589-7500(25)00012-3/fulltext

Effectiveness of home-based cardiac rehabilitation ... This study aims to assess the effects of mHealth HBCR interventions compared with usual care and CBCR in patients with heart disease.

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2828802

Rehabilitation at Home Using Mobile Health for Older ... This randomized clinical trial investigates whether a home-based mobile health cardiac rehabilitation intervention improves 6-minute walk ...

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Effectiveness of home-based exercise delivered by digital ... The HBE programmes carried out by DHI improve physical function in terms of lower extremity strength and functional capacity.

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Connected mHealth | Digital Value-Based Care Platform Revolutionize physiotherapy with Connected mHealth. Deliver personalized mobile interventions to enhance patient engagement and outcomes.

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Harnessing Mobile Health Technology for Secondary ... mHealth technologies can be used for health promotion to engage older adults in self-managing selected health parameters known to increase CVD ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9644389/

Uses of mHealth in Injury Prevention and Control mHealth is being used to measure, predict, and prevent the full spectrum of injuries. However, most literature remains preliminary or in a pilot stage.