Our aim is to conduct a pilot single-blind randomized controlled trial to examine the preliminary efficacy of a 14 day app-based pulmonary and mobility focused rehabilitation program (intervention arm) versus a self-guided exercise program (active control arm) on pulmonary and functional outcomes in 100 patients tested for COVID-19 infection and isolated at home.
As of April 20, 2020, there had been over 2.4 million confirmed cases of coronavirus disease
2019 (COVID-19) reported globally; 759,786 cases in USA. Triage protocols have been developed
to prioritize individuals for COVID-19 testing based on exposure or symptoms. Due to the high
demand for screening, the turnaround time for results in our area varies from 5-6 days. While
current estimates suggest that 80% of individuals will have mild illness, there is no
reliable way to predict course. Also some patients may rapidly deteriorate a week after
illness onset. No proven preventive or therapeutic options are yet available for individuals
with mild symptoms who are tested for COVID-19 infection, and asked to self-isolate
themselves at home while awaiting results.
COVID-19 is mainly a respiratory disease. Complications such as pneumonia and acute
respiratory distress syndrome (ARDS) are among its most dreaded complications, and major
contributors to Intensive Care Unit admissions and mortality. Early studies show that dyspnea
occurs at a median of 6 days after initial symptom onset, which can progress to ARDS at a
median of 12 days after onset. Hence, there is a window of 3-4 days after symptom onset
(corresponds to the time individuals typically wait for test results) that interventions
could be applied to prevent progression. Pulmonary and functional rehabilitation has proven
validity in preventing worsening of pulmonary and physical function in respiratory diseases.
But the utility of rehabilitation has not yet been established in the COVID-19 patient
population.
Based on our research in frail older adults and input from experts, the investigators
recently developed and published an innovative stratified self-guided care and exercise
manual for patients with COVID-19 infection to improve pulmonary function and prevent
immobility. The investigators build on this experience to test the efficacy of a
telephone-based app (PT-Pal™) version of this pulmonary and mobility focused rehabilitation
program. The PT-Pal is a validated cloud-based patient engagement platform that enables
management of patient care by sending treatment plans, surveys and reminders to the patient's
mobile device using HIPAA compliant secure messaging.
Our aim is to conduct a pilot single-blind randomized controlled trial in 100 patients tested
for COVID-19 infection and isolated at home who will be randomized into either a 14 day
PT-Pal pulmonary and mobility focused rehabilitation program or a self-guided exercise group.
Compared to participants in the active control group, the investigators hypothesize that
participants in the PT-Pal program will show lesser declines in self-reported pulmonary (St
George's Respiratory questionnaire) and physical function (AM-PAC basic mobility
questionnaire) due to greater participation and adherence rates. The investigators will test
at baseline, day and day 14 to determine trajectories in both groups. All outcomes will be
collected remotely as social distancing precludes in-person testing. At our recruitment site,
40-45% of individuals tested for COVID-19 had a positive result, but given current delays in
obtaining results (5-6 days), the investigators will enroll participants before knowing their
COVID-19 status.
The investigators will also examine the following secondary outcomes obtained remotely:
Pulmonary function (breath holding and peak flow), Physical function (5 times sit to stand
test), Health events (Emergency Room visits, hospitalizations), Psychological
(anxiety/depressive symptoms), and Feasibility metrics (sessions completed).
Our pilot clinical trial will build the evidence base for a rehabilitative approach to be
applied alongside emerging therapies to ameliorate the devastating pulmonary and physical
function declines seen in COVID-19 infection. It can be implemented in the time window
between presentation and development of severe symptoms in the large population of adults
awaiting test results in the community. Our approach can also apply to COVID-19 patients such
as those discharged from hospitals or healthcare workers furloughed home due to disease
exposure.
Behavioral: PT-Pal
Participants will be guided through an exercise program in the PT-Pal app. The program is stratified into 3 levels. Participants begin with Level 1 exercises to prevent atelectasis, strengthen inspiratory and expiratory muscles. Gradually exercises to stretch limb and chest wall muscles, build sitting tolerance and to improve transfer ability are added. These exercises can improve respiratory vital capacity. Level 2 focuses on sitting tolerance, strengthening limb and accessory muscles of breathing. Level 3 focuses on standing balance, large muscle strengthening, and building cardiopulmonary endurance.
Each exercise is done 2-3 times, and gradually increased to a complete set of 8. Each set is then repeated 2-3 per day, building up tolerance and fitness. Duration of session varies from 10 min initially up to 45 min later depending on fitness.
Behavioral: Self-guided exercises
Participants will use the exercise manual to guide the exercise program. The program is stratified into 3 levels. Participants begin with Level 1 exercises to prevent atelectasis, strengthen inspiratory and expiratory muscles. Gradually exercises to stretch limb and chest wall muscles, build sitting tolerance and to improve transfer ability are added. These exercises can improve respiratory vital capacity. Level 2 focuses on sitting tolerance, strengthening limb and accessory muscles of breathing. Level 3 focuses on standing balance, large muscle strengthening, and building cardiopulmonary endurance.
Each exercise is done 2-3 times, and gradually increased to a complete set of 8. Each set is then repeated 2-3 per day, building up tolerance and fitness. Duration of session varies from 10 min initially up to 45 min later depending on fitness.
Inclusion Criteria:
1. Age 18 and older.
2. Symptoms suggestive of Covid-19 infection (fever, cough, chest discomfort or loss of
smell/taste).
3. Covid-19 screening done.
4. Ambulatory without assistive devices (such as cane or walker).
5. Access to PT-Pal app via cellular phone, iPad or computer (e.g. Zoom™).
Exclusion Criteria:
1. Severe symptoms requiring referral to the Emergency Department.
2. Contraindications to exercise (cardiac disease such as diagnosed arrhythmias, on home
oxygen, or end stage organ failure).
3. Known history of poorly controlled diabetes or hypertension.
4. Active neurological or psychiatric illnesses.