Image

REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

REmotely Monitored, Mobile Health Supported Multidomain Rehabilitation Program With High Intensity Interval Training for COVID-19

Recruiting
18 years and older
All
Phase N/A

Powered by AI

Overview

Multicenter, prospective, randomized controlled trial providing mobile health supported physical rehabilitation to 120 patients who have been critically ill with COVID-19 and who complete at least one exercise session.

Description

REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) to improve recovery after hospital discharge in patients with COVID-19 will evaluate the feasibility of clinical-, physiological- and patient-centered outcomes associated with a remotely monitored, mobile health-supported high intensity interval rehabilitation exercise training to improve the functional recovery of survivors who have experienced critical illness with COVID-19 and have been discharged home from the hospital.

Eligibility

Inclusion Criteria:

  • Primary diagnosis of COVID-19 requiring hospital admission
  • Discharged or expected to be discharged directly home from the hospital (not to a skilled nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
  • Able to ambulate with or without a gait aid prior to hospital discharge
  • Age ≥ 18 years

Exclusion Criteria:

  • Hospital discharge > 60 days unless readmitted to hospital in first 30 days, then 60 day window restarts and new exclusion is last hospital discharge > 60 days
  • Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
  • Functional impairment resulting in inability to exercise at baseline
  • Inability or unwillingness to comply with the study requirements or unable or unwilling to follow coaching via mobile-health iPhone interaction
  • Any absolute contraindications to exercise, including but not limited to:
    • Recent (< 5 days) acute primary cardiac event
    • Unstable Angina
    • Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
    • Uncontrolled hypertension over 255 mmHg Systolic or 155 diastolic blood pressure
    • Symptomatic aortic stenosis
    • Uncontrolled symptomatic heart failure
    • Acute myocarditis or pericarditis
    • Suspected or known dissecting aneurysm
  • Any adverse changes during IST (i.e., persistent oxygen saturation drop below 88%

    while on prescribed oxygen therapy or significant hypotension such as mean arterial blood pressure < 60 mmHg on 2 consecutive readings within 1 minute)

  • High risk for non-adherence as determined by screening evaluation
  • Any condition, including cognitive impairment, that, in the judgment of the investigator, precludes participation because it could affect subject safety or ability of subject to complete the study
  • Pregnant

Study details
    COVID-19
    Critical Illness
    ICU Acquired Weakness
    PICS
    Cardiorespiratory Fitness

NCT05218083

Duke University

17 May 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.