Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate whether a home rehabilitation program after hospitalization for acute pulmonary embolism (PE) improves clinical outcomes at 3 months compared to usual care. Daily physical activity tasks that incorporate heart rate monitoring will be sent through email or text. This information could help improve the management of acute PE.
Is the Home Rehabilitation Program a promising treatment for pulmonary embolism?Yes, the Home Rehabilitation Program is a promising treatment for pulmonary embolism. It can improve physical capacity, quality of life, and sleep quality. Patients who participated in home-based rehabilitation showed improvements in their general and physical health, and many reported long-term health benefits.3791011
What safety data exists for home rehabilitation for pulmonary embolism?The safety data for home rehabilitation programs, which may include self-monitored exercise and remote monitoring, suggest that these programs are generally safe for cardiac patients. Studies have shown that home-based exercise programs with monitoring, such as transtelephonic electrocardiographic monitoring and wearable sensors, are feasible and do not typically result in medical emergencies. These programs allow for the detection of specific issues that can be addressed, ensuring patient safety. The use of remote monitoring systems in cardiac rehabilitation has been piloted successfully, indicating that similar approaches could be safe for pulmonary embolism rehabilitation.125812
What data supports the idea that Home Rehabilitation for Pulmonary Embolism is an effective treatment?The available research shows that home rehabilitation for pulmonary embolism can improve patients' quality of life and physical health. One study found that both supervised and unsupervised home rehabilitation programs led to better general and physical health scores, as well as improved sleep quality. Another study reported significant improvements in exercise capacity, with patients walking longer distances after completing a rehabilitation program. Additionally, most patients experienced long-term health benefits. These findings suggest that home rehabilitation is a beneficial treatment for those recovering from pulmonary embolism.467911
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.
Eligibility Criteria
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.
Exclusion Criteria
My condition involves advanced neurological issues.
I might have high blood pressure in my lungs due to clots.
I am unable to walk.
My heart rate increases by more than 2.5 beats per minute during a 6-minute walk test.
Treatment Details
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.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Participants who receive daily activity messageExperimental Treatment1 Intervention
The intervention group will receive instructions for a daily activity sent through SMS text message or email.
Group II: Participants who receive control messagePlacebo Group1 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".
Find a clinic near you
Research locations nearbySelect from list below to view details:
University of Rochester Medical CenterRochester, NY
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Who is running the clinical trial?
University of RochesterLead Sponsor
American College of Chest PhysiciansCollaborator
References
Transtelephonic electrocardiographic monitoring of cardiac rehabilitation exercise sessions in coronary artery disease. [2019]Transtelephonic monitoring of a single-lead electrocardiogram and on-demand 2-way voice communication were accomplished at 1,865 exercise sessions for 67 cardiac patients. Exercise sessions occurred either at the patients' homes or at remote hospital sites and began an average of 25 or 14 weeks, respectively, after hospital dismissal. Monitoring centers provided experienced nurses to direct all exercise sessions. The transtelephonic monitoring equipment was reliable with only one instance of system failure observed. A broad spectrum of patients with coronary artery disease, including some classified at higher risk, participated in the program. Patients exercised with a variety of equipment (cycle ergometer, treadmill, arm ergometer, cross-country ski simulator, combination arm-leg cycle ergometer, rowing machine), for 30 to 50 minutes, 1 to 3 times each week. No medical emergencies occurred, although 18 specific problems were discovered that led to further evaluation or change in the medical program of specific patients. Transtelephonic monitoring of cardiac rehabilitation exercise sessions at home and at remote hospitals appears safe and is attractive because not all patients have access to supervised exercise programs; this exercise assessment helps to maximally use highly trained cardiac rehabilitation personnel.
Safety and feasibility of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery. [2008]To determine the safety and effectiveness of a self-monitored, home-based phase II exercise program for high risk patients after cardiac surgery.
A Canadian, multicentre, randomized clinical trial of home-based pulmonary rehabilitation in chronic obstructive pulmonary disease: rationale and methods. [2018]Pulmonary rehabilitation remains largely underused. Self-monitored, home-based rehabilitation is a promising approach to improving the availability of pulmonary rehabilitation.
Management of pulmonary embolism in the home. [2020]To describe the characteristics, outcomes and treatment complications of patients with pulmonary embolism (PE) who were treated at home and as outpatients in an ambulatory care program.
Determination of the effectiveness of accelerometer use in the promotion of physical activity in cardiac patients: a randomized controlled trial. [2016]To investigate the effect of the self-monitoring of physical activity by hospitalized cardiac patients attending phase I cardiac rehabilitation (CR).
Functional and Exercise Limitations After a First Episode of Pulmonary Embolism: Results of the ELOPE Prospective Cohort Study. [2022]We aimed to determine the frequency and predictors of exercise limitation after pulmonary embolism (PE) and to assess its association with health-related quality of life (HRQoL) and dyspnea.
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. [2018]The existing evidence base in pulmonary embolism (PE) is primarily focused on diagnostic methods, medical treatment, and prognosis. Only a few studies have investigated how everyday life is affected by PE, although many patients are negatively affected both physically and emotionally after hospital discharge. Currently, no documented rehabilitation options are available for these patients. We aim to examine whether an 8-week home-based exercise intervention can influence physical capacity, quality of life, sick leave, and use of psychotropic drugs in patients medically treated for PE.
Implementing Wearable Sensors for Continuous Assessment of Daytime Heart Rate Response in Inpatient Rehabilitation. [2020]It is unclear whether wearable heart rate (HR) sensors can be worn continuously in inpatient rehabilitation to assess cardiorespiratory training response. If feasible, these sensors offer a low-cost low-maintenance method for assessing HR response in this setting. We determined feasibility of wearable sensors for assessing HR response to daytime therapy activities in inpatient rehabilitation within a cardiorespiratory training zone equal to 55-80% of maximal HR (target HR [THR]) for at least two 10-min bouts, 3-5 days per week. Secondarily, we determined episodes of excessive HR (EHR >80% of maximal HR).
Outpatient Pulmonary Rehabilitation in Patients with Persisting Symptoms after Pulmonary Embolism. [2020]Background: Patients with pulmonary embolism (PE) may suffer from long-term consequences, including decreased functional capacity. Data on pulmonary rehabilitation (PR) in patients with PE are scarce, and no data on outpatient PR are available so far. Methods: We analyzed data of 22 PE patients who attended outpatient PR due to exertional dyspnea. Patients underwent a multi-professional 6-week PR program. The primary outcome was change in 6-min walk test (6MWT). Secondary outcomes included changes in strength and endurance tests. To assess long-term benefits, follow-up was performed a median of 39 months after PR. Results: Patients started PR a median of 19 weeks after the acute PE event. Their median age was 47.5 years, 33% were women and all presented with NYHA (New York Heart Association) class II and higher. After PR, patients showed significant and clinically relevant improvements in 6MWT (mean difference: 49.4 m [95% CI 32.0-66.8]). Similarly, patients increased performance in maximum strength, endurance and inspiratory muscle strength. At long-term follow-up, 78% of patients reported improved health. Conclusion: We observed significant improvements in exercise capacity in PE patients undergoing outpatient PR. The majority of patients also reported a long-term improvement in health status. Prospective studies are needed to identify patients who would benefit most from structured PR.
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. [2021]Recently, a large group of patients with persistent dyspnea, poor physical capacity, and reduced health-related quality of life (HRQoL) following pulmonary embolism (PE) has been identified and clustered under the name "post pulmonary embolism syndrome" (PPS). These patients seem good candidates for pulmonary rehabilitation. The aim of the study is to explore whether a pulmonary rehabilitation program can improve physical capacity, dyspnea, and HRQoL in PPS patients.
Supervised Versus Unsupervised Pulmonary Rehabilitation in Patients with Pulmonary Embolism: A Valuable Alternative in COVID Era. [2021]The aim of our study was to assess the effect of 8 weeks of pulmonary rehabilitation (PR) in patients with pulmonary embolism (PE) during unsupervised PR (unSPRgroup) versus supervised PR (SPRgroup) on cardiopulmonary exercise testing (CPET) parameters, sleep quality, quality of life and cardiac biomarkers (NT-pro-BNP). Fourteen patients with PE (unSPRgroup, n = 7, vs. SPRgroup, n = 7) were included in our study (age, 50.7 ± 15.1 years; BMI, 30.0 ± 3.3 kg/m2). We recorded anthropometric characteristics and questionnaires (Quality of life (SF-36) and Pittsburg sleep quality index (PSQI)), we performed blood sampling for NT-pro-BNP measurement and underwent CPET until exhausting before and after the PR program. All patients were subjected to transthoracic echocardiography prior to PR. The SPRgroup differed in mean arterial pressure at rest before and after the PR program (87.6 ± 3.3 vs. 95.0 ± 5.5, respectively, p = 0.010). Patients showed increased levels of leg fatigue (rated after CPET) before and after PR (p = 0.043 for SPRgroup, p = 0.047 for unSPRgroup) while the two groups differed between each other (p = 0.006 for post PR score). Both groups showed increased levels in SF-36 scores (general health; p = 0.032 for SPRgroup, p = 0.010 for unSPRgroup; physical health; p = 0.009 for SPRgroup, p = 0.022 for unSPRgroup) and reduced levels in PSQI (cannot get to sleep within 30-min; p = 0.046 for SPRgroup, p = 0.007 for unSPRgroup; keep up enough enthusiasm to get things done; p = 0.005 for SPRgroup, p = 0.010 for unSPRgroup) following the PR program. The ΝT-pro-BNP was not significantly different before and after PR or between groups. PR may present a safe intervention in patients with PE. The PR results are similar in SPRgroup and unSPRgroup.
Safety and Feasibility of Tele-Cardiac Rehabilitation Using Remote Biological Signal Monitoring System: A Pilot Study. [2023]Cardiac rehabilitation (CR) is categorized as a class I recommendation in the guidelines for the management of patients with cardiovascular disease (CVD). However, the penetration rate of outpatient CR is low in Japan. We designed a pilot study to evaluate the safety and feasibility of tele-CR using a remote biological signal monitoring system.