Home Rehabilitation for Pulmonary Embolism

Overseen By Daniel Lachant, DO

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Pregnancy, Tachycardia, Hypertension, Neurologic disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a home rehab program can improve recovery after hospitalization for a pulmonary embolism (a blood clot in the lungs). Participants receive daily messages with physical activity tasks to complete at home, guided by heart rate monitoring. The trial includes two groups: one receives activity messages as part of the Home Rehabilitation Program, while the other receives general supportive messages. It seeks individuals who recently experienced a pulmonary embolism and can follow daily instructions via email or text. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance recovery methods for future patients.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more information.

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

What prior data suggests that this home rehabilitation program is safe for pulmonary embolism patients?

Research shows that low-to-moderate-intensity exercise is safe for people in the United States who have had a pulmonary embolism (PE). This indicates that exercise programs like the one in this study are usually manageable for participants. Other studies have shown that patients successfully completed similar exercise routines at home with help from health professionals. These programs involve activities that participants can monitor themselves, such as tracking their heart rate. No major reports of problems or issues directly caused by the exercise have emerged. This suggests that the approach used in this study is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to managing pulmonary embolism recovery at home. Unlike standard treatments such as anticoagulant medications, which focus on preventing further clots, this trial examines the impact of daily activity guidance delivered through text messages or emails. This method could empower patients by encouraging physical activity in a simple, tech-friendly way that seamlessly integrates into their daily routine. By focusing on home rehabilitation, this trial aims to improve recovery outcomes and overall quality of life for patients with pulmonary embolism.

What evidence suggests that this home rehabilitation program is effective for pulmonary embolism?

This trial will compare a home rehabilitation program with a control group for individuals recovering from a pulmonary embolism (PE), a blockage in one of the lung arteries. Participants will either receive daily activity messages as part of the home rehabilitation program or control messages without activity tasks. Studies have shown that home rehabilitation programs can be safe for those recovering from PE. Research indicates that light to moderate exercise after a PE is generally safe. However, some studies found that exercise-based rehabilitation did not significantly increase daily physical activity compared to regular care. Despite this, the treatment was mostly safe, with only 2% of participants experiencing major bleeding and 3% passing away within three months. This suggests that home rehabilitation might help some manage their recovery from PE, but its effect on increasing physical activity remains unclear. ^{1 3 4 5 6}

Who Is on the Research Team?

Daniel Lachant

Principal Investigator

University of Rochester

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 18 who've been hospitalized with acute pulmonary embolism and show certain heart issues. They must be able to start the program within a week of leaving the hospital, walk on their own, and have access to email or text messaging.

Inclusion Criteria

I have a blood clot in my lungs with heart strain.

Baseline testing started within 7 days of hospital discharge.

Exclusion Criteria

Lack of access to email or text messaging.

My condition involves advanced neurological issues.

Inability to follow daily instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily physical activity tasks sent through email or text, incorporating heart rate monitoring

12 weeks

Remote monitoring via email or text

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Control Text
• Daily Activity Text

Trial Overview The study tests if a home rehab program using daily physical activity tasks sent via email or text can improve outcomes after an acute pulmonary embolism compared to usual care. Heart rate is monitored during these activities.

How Is the Trial Designed?

Group I: Participants who receive daily activity message Experimental Treatment 1 Intervention

The intervention group will receive instructions for a daily activity sent through SMS text message or email.

Group II: Participants who receive control message Placebo Group 1 Intervention

The control group will receive daily messages to help with blinding sent through text message or email. The messages will not include activity tasks and will include phrases such as "I hope you have a good day".

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

American College of Chest Physicians

Collaborator

Trials

10

Recruited

2,200+

Published Research Related to This Trial

Transtelephonic monitoring of exercise sessions for 67 cardiac patients was found to be safe and reliable, with only one system failure reported during 1,865 sessions, indicating its effectiveness for remote cardiac rehabilitation.

The program successfully identified 18 specific health issues in patients without any medical emergencies, demonstrating that remote monitoring can enhance patient safety and optimize the use of cardiac rehabilitation resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transtelephonic electrocardiographic monitoring of cardiac rehabilitation exercise sessions in coronary artery disease. Squires, RW., Miller, TD., Harn, T., et al.[2019]

In a randomized controlled trial involving 126 hospitalized cardiac patients, those who engaged in self-monitoring of their physical activity significantly increased their daily steps and energy expenditure before transitioning to phase II cardiac rehabilitation, compared to those who did not self-monitor.

The self-monitoring group averaged 8609.6 steps and 242.6 kcal of energy expenditure, while the control group averaged only 5512.9 steps and 155.9 kcal, indicating that self-monitoring can effectively enhance physical activity levels in cardiac patients during recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determination of the effectiveness of accelerometer use in the promotion of physical activity in cardiac patients: a randomized controlled trial. Izawa, KP., Watanabe, S., Hiraki, K., et al.[2016]

An 8-week home-based exercise program is being tested on 140 patients with first-time pulmonary embolism (PE) to see if it can improve their physical capacity and quality of life after hospital discharge.

The study aims to fill a gap in rehabilitation options for PE patients, as current evidence mainly focuses on diagnosis and treatment, and it may lead to future recommendations for better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does an 8-week home-based exercise program affect physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients with pulmonary embolism? Study protocol for a multicenter randomized clinical trial. Rolving, N., Brocki, BC., Mikkelsen, HR., et al.[2018]

A self-monitored, home-based exercise program for high-risk cardiac surgery patients was found to be safe, with no cardiovascular complications reported during the eight-week training period.

However, the exercise program did not significantly improve aerobic capacity compared to a control group that received general activity guidelines, indicating that the home-based approach may not provide additional benefits in this specific patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and feasibility of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery. Brosseau, R., Juneau, M., Sirard, A., et al.[2008]

Pulmonary rehabilitation (PR) over 8 weeks is safe and beneficial for patients with pulmonary embolism (PE), showing improvements in quality of life and sleep quality for both supervised (SPR) and unsupervised (unSPR) groups.

Both groups experienced significant enhancements in general and physical health scores, as well as reductions in sleep disturbances, indicating that PR can effectively support recovery in PE patients regardless of supervision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supervised Versus Unsupervised Pulmonary Rehabilitation in Patients with Pulmonary Embolism: A Valuable Alternative in COVID Era. Stavrou, VT., Griziotis, M., Vavougios, GD., et al.[2021]

Outpatient pulmonary rehabilitation (PR) for patients with pulmonary embolism (PE) led to significant improvements in exercise capacity, as measured by the 6-minute walk test, with an average increase of 49.4 meters after a 6-week program involving 22 patients.

At a median follow-up of 39 months, 78% of patients reported long-term improvements in their health status, indicating that PR can have lasting benefits for PE patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient Pulmonary Rehabilitation in Patients with Persisting Symptoms after Pulmonary Embolism. Nopp, S., Klok, FA., Moik, F., et al.[2020]

This trial will compare the effectiveness of self-monitored, home-based rehabilitation versus traditional hospital-based rehabilitation in 240 patients with moderate to severe COPD, aiming to determine if home-based methods can be as effective in improving patients' breathing difficulties over 12 months.

The study will also evaluate whether home-based rehabilitation can lead to reduced healthcare usage and lower costs compared to hospital-based rehabilitation, addressing important gaps in pulmonary rehabilitation accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. Maltais, F., Bourbeau, J., Lacasse, Y., et al.[2018]

The pilot study involving nine patients with cardiovascular disease demonstrated that tele-cardiac rehabilitation (tele-CR) using a remote biological signal monitoring system is safe, with no instances of monitoring failures during exercise therapy.

Participants showed significant improvements in exercise capacity after three months of tele-CR, indicating that this remote approach can effectively enhance rehabilitation outcomes for patients with cardiovascular disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. Nishitani-Yokoyama, M., Shimada, K., Fujiwara, K., et al.[2023]

In a study of 130 patients with pulmonary embolism (PE), 46% were treated entirely as outpatients, and 54% were discharged early, with a successful completion rate of 89% for the treatment program.

The treatment was generally safe, with only 2% experiencing major bleeding and 3% dying within 3 months, indicating that selected patients with sub-massive PE can be effectively managed at home, though careful monitoring is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of pulmonary embolism in the home. Ong, BS., Karr, MA., Chan, DK., et al.[2020]

Nearly 46.5% of patients with acute pulmonary embolism (PE) experienced exercise limitations one year after their diagnosis, which negatively impacted their health-related quality of life (HRQoL) and walking distance.

Key predictors of exercise limitation included male sex, age, body mass index (BMI), smoking history, and initial exercise capacity measured by peak oxygen uptake (Vo2 peak) and 6-minute walk distance (6MWD) at one month post-PE.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. Kahn, SR., Hirsch, AM., Akaberi, A., et al.[2022]

A randomized controlled trial is investigating the effects of an 8-week pulmonary rehabilitation program on patients with post pulmonary embolism syndrome (PPS), aiming to improve their physical capacity, dyspnea, and health-related quality of life (HRQoL).

The study will assess outcomes using various tests and questionnaires, with 190 patients currently being recruited, potentially providing a new effective treatment for those suffering from PPS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary rehabilitation to improve physical capacity, dyspnea, and quality of life following pulmonary embolism (the PeRehab study): study protocol for a two-center randomized controlled trial. Haukeland-Parker, S., Jervan, Ø., Johannessen, HH., et al.[2021]

In a study involving patients aged 44-80 in inpatient rehabilitation, 60% of subjects achieved target heart rate (THR) levels necessary for cardiorespiratory benefits, indicating that wearable heart rate sensors are effective for monitoring training responses.

The study found that 47% of subjects experienced episodes of excessive heart rate (EHR), but importantly, there were no adverse events related to the sensors, demonstrating their safety and feasibility for continuous monitoring in a rehabilitation setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Wearable Sensors for Continuous Assessment of Daytime Heart Rate Response in Inpatient Rehabilitation. Weeks, DL., Sprint, GL., Stilwill, V., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8674950/

Application of pulmonary rehabilitation in patients with ... Low-to-moderate-intensity exercise therapy following acute PE is considered safe in the United States (62). German researchers have established a personalized ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05571189

Home Rehabilitation After Acute Pulmonary Embolism The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical ...

3. thrombosisresearch.com thrombosisresearch.com/article/S0049-3848(25)00112-4/fulltext

The effect of exercise-based rehabilitation on objective ... The effect of exercise on physical activity after pulmonary embolism is unknown. Physical activity was assessed before and after exercise-based rehabilitation.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0049384825001124

The effect of exercise-based rehabilitation on objective ... In this cohort, exercise-based rehabilitation following PE did not change daily physical activity levels compared to usual care control group.

5. withpower.com withpower.com/trial/home-rehabilitation-for-pulmonary-embolism-73a67

Home Rehabilitation for Pulmonary Embolism The treatment was generally safe, with only 2% experiencing major bleeding and 3% dying within 3 months, indicating that selected patients with sub-massive PE ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7049077/

Effect of a Physiotherapist-Guided Home-Based Exercise ... This randomized clinical trial investigates the effect of a rehabilitation intervention, comprising an 8-week home-based exercise program and nurse ...