Home Rehabilitation After Acute Pulmonary Embolism

University of Rochester

Status: Active, not recruiting

Conditions: Pulmonary Embolism

Treatments: Behavioral: Daily Activity Text; Behavioral: Control Text

Study type: Interventional

Funder types: Other

Identifiers

NCT05571189

STUDY00007680

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• English speaking (>18 years old). Daily messages will be sent in English.
• Acute PE with right ventricular enlargement or dysfunction defined by echocardiogram report, CT Angiogram report, or elevated cardiac biomarker (NT-pro BNP or troponin).
• Baseline testing started within 7 days of hospital discharge.

Exclusion criteria

• Pregnancy.
• Cardiac Effort >2.5 beats/m during 6MWT. This is for safety.
• Cardiac Effort <1.2 beats/m during 6MWT. They are unlikely to benefit.
• Resting tachycardia >120 beats/m during screening or at hospital discharge.
• Suspicion for Chronic Thromboembolic Pulmonary Hypertension.
• Systolic blood pressure >180 mmHg during screening or at hospital discharge.
• Inability to walk.
• Estimated prognosis <12 months at the time of discharge due to underlying co-morbidities.
• Advanced neurologic disease.
• Lack of access to email or text messaging.
• Inability to follow daily instructions.
• Participation in a structured exercise routine at least three days per week in the prior four weeks.
• Principal Investigator discretion

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Participants who receive daily activity message

Experimental group

Description:

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

Treatment:

Behavioral: Daily Activity Text

Participants who receive control message

Placebo Comparator group

Description:

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".

Treatment:

Behavioral: Control Text