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

80 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the effects of a home-based exercise program using mobile technology on physical activity and capacity, frailty and muscle mass, and quality of life in patients with a newly implanted HeartMate 3 left ventricular assist device (HM3 LVAD). Researchers will compare the effects of an exercise intervention vs. usual care on physical activity and capacity, frailty and muscle mass, and quality of life.

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 data supports the effectiveness of the treatment Home-Based Exercise Program Using Mobile Technology for heart failure?

Research shows that home cardiac rehabilitation guided by mobile technology can improve heart function, exercise tolerance, and quality of life in heart failure patients. A study found that patients using mobile technology for home rehabilitation had better outcomes in a walking test and quality of life scores compared to those who did not use the technology. ^{1 2 3 4 5}

Is home-based exercise safe for heart failure patients?

Research shows that home-based exercise programs, including those using mobile technology, are generally safe for heart failure patients, with low rates of adverse events reported. ^{3 5 6 7 8}

How is the Home-Based Exercise Program Using Mobile Technology treatment different from other treatments for heart failure?

This treatment is unique because it allows heart failure patients to exercise at home using mobile technology, making it more accessible and potentially increasing adherence compared to traditional center-based cardiac rehabilitation programs. ^{2 6 9 10 11}

Research Team

Himabindu Vidula, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

Owns a smartphone with Internet connection

I am 18 years old or older.

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

Exclusion Criteria

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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]

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]

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]

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]

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]

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]

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]

References

1. England 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. [2021]

2. Germany 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. [2021]

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

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

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

Effects of a home-based exercise program on clinical outcomes in heart failure. [2007]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Comparison of Supervised Hospital-based versus Educated Home-based Exercise Training in Korean Heart Failure Patients. [2020]

6. Australia 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. [2019]

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

Feasibility study of home telerehabilitation for physically inactive veterans. [2019]

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

Home resistance training in an elderly woman with coronary heart disease. [2019]

9. Portugal pubmed.ncbi.nlm.nih.gov

Home- versus centre-based EXercise InTervention in patients with Heart Failure (EXIT-HF trial): A pragmatic randomized controlled trial. [2023]

10. Poland pubmed.ncbi.nlm.nih.gov

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

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

Home-based telehealth exercise training program in Chinese patients with heart failure: A randomized controlled trial. [2023]