Home-Based Exercise for Heart Failure

(MOVE-LVAD II Trial)

Recruiting at 3 trial locations

Overseen By Clinical Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Orthopedic, Neurologic, Heart failure, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how a home-based exercise program using mobile technology can benefit individuals with a new HeartMate 3 left ventricular assist device (LVAD). The researchers aim to determine if this exercise program can improve physical activity, muscle strength, and quality of life compared to usual care. Participants will either follow a guided exercise plan using a smartphone app or maintain their normal daily routine. This trial suits individuals living at home with a newly implanted HeartMate 3 LVAD who can walk independently and have a smartphone with internet access. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance daily life for LVAD patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this home-based exercise program using mobile technology is safe for patients with a HeartMate 3 left ventricular assist device?

Research has shown that exercising at home with mobile technology is generally safe for people with heart conditions. A review of studies found that patients with heart disease respond well to these programs. Participants typically exercise at home using digital tools like fitness watches and smartphone apps, which assist them in following their exercise plans.

Another study found that mobile health (mHealth) technology can safely help people develop exercise habits. This technology enables patients to exercise independently and share their progress with healthcare providers. This approach not only tracks exercise but also ensures it is done safely.

In summary, using mobile technology to guide home exercise appears to be a safe and effective option for people with heart conditions, including those with heart devices. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the home-based exercise program for heart failure because it utilizes mobile technology to provide a personalized and flexible approach to exercise. Unlike traditional cardiac rehab programs that require in-person attendance, this program leverages activity-tracking watches and smartphone apps to guide and progress exercise routines at home. This method not only enhances accessibility for patients who may struggle with transportation or time constraints but also encourages consistent physical activity, which is crucial for improving heart health. By integrating technology, this exercise program offers a modern, convenient, and potentially more sustainable way to manage heart failure symptoms.

What evidence suggests that this home-based exercise program using mobile technology is effective for heart failure patients with a newly implanted HeartMate 3 LVAD?

Research shows that home-based exercise programs using mobile technology can effectively boost physical activity and fitness in heart patients. In this trial, participants in the Exercise Intervention arm will follow such a program, which studies have shown to improve fitness levels as effectively as traditional supervised programs. Specifically, past participants demonstrated better walking ability, an important measure of fitness. Additionally, mobile technology aids in maintaining exercise routines by providing guidance and tracking progress. Overall, home-based exercise programs offer a promising way to improve health in patients with heart conditions. ^{2 3 6 7 8}

Who Is on the Research Team?

Himabindu Vidula, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've just had a HeartMate 3 LVAD implanted and can walk on their own (even with help from a device). They must have a smartphone with internet because the exercise program uses mobile tech. It's for those going home or living at home with the LVAD within 45 days after leaving the hospital.

Inclusion Criteria

Newly implanted with a HeartMate 3™ LVAD for the first time

Owns a smartphone with Internet connection

Patient will be discharged home with LVAD or patient will be living at home with LVAD within 45 days of index discharge

Exclusion Criteria

I don't have major health issues that would stop me from exercising.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline assessments including daily step measurement, six-minute walk test, frailty testing, and CT scan for muscle mass evaluation

1 week

1 visit (in-person)

Treatment

Participants are randomized to either the exercise intervention or usual care. The exercise group receives personalized exercise prescriptions and remote monitoring, while the usual care group is encouraged to increase walking

6 months

Regular follow-up VAD Clinic appointments (in-person), video calls (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including questionnaires, six-minute walk testing, frailty testing, and CT scans

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Home-Based Exercise Program Using Mobile Technology

Trial Overview The study looks at how well patients do on a home-based exercise program using their smartphones compared to usual care after getting an HM3 LVAD. Researchers want to see if this improves physical activity, reduces frailty, increases muscle mass, and betters quality of life.

How Is the Trial Designed?

Group I: Usual Care Experimental Treatment 1 Intervention

The usual care group will be encouraged to increase daily walking activity as they tolerate, while complying with any activity restrictions from their clinical team. The Physical Activity Guidelines for Americans recommend increasing daily walking activity as tolerated to an average of 30 minutes daily, 5 times a week.

Group II: Exercise Intervention Experimental Treatment 1 Intervention

The exercise intervention focuses on walking and strengthening exercises with a standardized protocol to guide exercise prescription and exercise progression based on data obtained from the activity tracking watch and smartphone app.

Home-Based Exercise Program Using Mobile Technology is already approved in United States for the following indications:

Approved in United States as Home-Based Exercise Program Using Mobile Technology for:

• Improvement of physical activity and capacity in patients with HeartMate 3 LVAD
• Reduction of frailty and muscle mass loss in patients with HeartMate 3 LVAD
• Enhancement of quality of life in patients with HeartMate 3 LVAD

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

This study is comparing the effectiveness and cost of home-based versus center-based cardiac rehabilitation (CR) programs for heart failure patients, involving 120 participants over a 12-week period.

The primary goal is to assess changes in peak oxygen uptake (VO2peak), with secondary outcomes including physical fitness, quality of life, and cost-effectiveness, aiming to provide valuable insights for healthcare professionals in Portugal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial. Schmidt, C., Magalhães, S., Gois Basilio, P., et al.[2023]

The study successfully developed a Health Buddy (HB) text messaging system to monitor home exercise in physically inactive older adults, showing it is a safe method with low adverse event rates.

Participants using the HB system demonstrated better exercise adherence compared to those monitored by telephone, although adherence declined for both methods after 8 weeks, indicating the need for ongoing support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility study of home telerehabilitation for physically inactive veterans. Harada, ND., Dhanani, S., Elrod, M., et al.[2019]

In a study of 82 heart failure patients, those who participated in supervised hospital-based exercise training showed significant improvements in functional capacity, with peak oxygen consumption increasing from 19.4 to 21.4 mL/min/kg, while home-based training did not show similar benefits.

Quality of life also improved significantly in the hospital-based group, but there were no significant differences in cardiac events between the two groups after one year, suggesting that while hospital-based training is more effective for immediate functional improvements, both training types have similar long-term safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Supervised Hospital-based versus Educated Home-based Exercise Training in Korean Heart Failure Patients. Kim, M., Kim, MS., Lim, SJ., et al.[2020]

Home-based exercise programs for adults with chronic heart failure significantly improved exercise capacity, increasing the 6-minute walking distance by an average of 41 meters and peak VO2 by 2.71 ml/kg/min compared to usual activity.

The exercise was found to be safe, with no increase in hospitalization rates, but it did not lead to improvements in quality of life as measured by the Minnesota Heart Failure Questionnaire.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based exercise increases exercise capacity but not quality of life in people with chronic heart failure: a systematic review. Chien, CL., Lee, CM., Wu, YW., et al.[2019]

Both home-based and hospital-based exercise programs significantly improved exercise capacity, quality of life, and left ventricular ejection fraction (LVEF) in heart failure patients after an 8-week rehabilitation program involving 74 participants.

There were no significant differences in outcomes between the two exercise groups, suggesting that home-based exercise can be a safe and effective alternative for stable heart failure patients under supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of hospital-based versus home-based exercise training in patients with heart failure: effects on functional capacity, quality of life, psychological symptoms, and hemodynamic parameters. Karapolat, H., Demir, E., Bozkaya, YT., et al.[2021]

A randomized controlled trial involving 169 heart failure patients found that a home-based exercise program combined with specialist nurse care did not significantly improve overall quality of life or heart failure symptoms compared to nurse care alone.

However, the exercise group did show some benefits, including improved generic quality of life and reduced anxiety and depression scores at 6 and 12 months, suggesting that while home-based exercise may not be broadly effective, it can have specific positive effects on mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of the addition of home-based exercise to specialist heart failure nurse care: the Birmingham Rehabilitation Uptake Maximisation study for patients with Congestive Heart Failure (BRUM-CHF) study. Jolly, K., Taylor, RS., Lip, GY., et al.[2021]

A study involving 98 heart failure patients in China showed that an 8-week home-based telehealth exercise program significantly improved quality of life and walking distance compared to usual care.

The benefits of the telehealth program were sustained for 4 months after the intervention, with no significant complications or adverse outcomes reported, highlighting its safety and efficacy as a cardiac rehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based telehealth exercise training program in Chinese patients with heart failure: A randomized controlled trial. Peng, X., Su, Y., Hu, Z., et al.[2023]

A home-based exercise program for patients with systolic heart failure did not improve overall clinical outcomes after 12 months, as measured by hospitalizations, emergency admissions, and mortality.

However, the exercise group experienced significantly fewer multiple hospitalizations (12.8% vs. 26.6% in the control group), indicating a potential benefit in reducing the frequency of hospital visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a home-based exercise program on clinical outcomes in heart failure. Dracup, K., Evangelista, LS., Hamilton, MA., et al.[2007]

A study involving 60 heart failure patients showed that those receiving home cardiac rehabilitation guided by mobile Internet technology had significantly better outcomes in exercise tolerance and quality of life after 12 weeks compared to those receiving standard rehabilitation.

The observation group demonstrated improved cardiac function, as indicated by better results in the 6-minute walking test and other cardiac health metrics, highlighting the efficacy of mobile technology in enhancing patient compliance and rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Mobile Internet Technology in Health Management of Heart Failure Patients Guiding Cardiac Rehabilitation. Liu, T., Liu, M.[2023]

A home-based resistive exercise program for an older woman with coronary artery disease and chronic heart failure led to significant improvements in muscle strength and lean body mass after 6 months.

The program, which included intermittent on-site instruction, suggests that home exercise can be an effective alternative for older patients who cannot attend rehabilitation centers, warranting further research in controlled trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home resistance training in an elderly woman with coronary heart disease. King, PA., Savage, P., Ades, PA.[2019]

Regular exercise training is highly recommended for heart failure patients, supported by strong evidence, yet many patients remain inactive due to various barriers.

Home telerehabilitation is proposed as an effective solution to encourage physical activity among heart failure patients, addressing the limitations of traditional outpatient rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How to do: telerehabilitation in heart failure patients. Piotrowicz, E.[2019]

Citations

1. 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.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11433441/

Effectiveness of Home-Based Cardiac Rehabilitation ... A 6-week home-based CR program with exercise readjustment using a mobile app can potentially enhance exercise capacity as effectively as verbal supervision.

3. 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2589790X25005153

Long-term effects of 3-month home-based cardiac ... This follow-up study found that the initial improvements in exercise tolerance and physical frailty status observed after 3-month ICT-based HBCR ...

5. ahajournals.org ahajournals.org/doi/10.1161/JAHA.120.020482

Mobile Technology Improves Adherence to Cardiac ... We found that adjunctive use of mobile technology is significantly associated with improved adherence to cardiac rehabilitation and number of attended sessions.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11757971/

Use of mHealth Technology for Improving Exercise ... The results show some preliminary evidence of the feasibility of using mHealth technology for building exercise adherence in patients with HF.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2590093525000128

Effectiveness, safety and adherence of home-based ... This systematic review aims to investigate the safety, effectiveness and adherence of home-based exercise rehabilitation in patients with coronary heart ...

8. ahajournals.org ahajournals.org/doi/10.1161/CIR.0000000000001150

Digital Technologies in Cardiac Rehabilitation: A Science ... In remote CR, patients exercise independently and can use digital technology to monitor exercise and then transmit those data to clinicians for ...