Covid-19NCT04406532
Home-Based Covid-19 Rehabilitation Program
A study testing PT-Pal and Self-guided exercises in people with Covid-19, run by Albert Einstein College of Medicine.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- PT-Pal and Self-guided exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 and older.
- Symptoms suggestive of Covid-19 infection (fever, cough, chest discomfort or loss of smell/taste).
- Covid-19 screening done.
- Ambulatory without assistive devices (such as cane or walker).
- Access to PT-Pal app via cellular phone, iPad or computer (e.g. Zoom™).
Who cannot join
- Severe symptoms requiring referral to the Emergency Department.
- Contraindications to exercise (cardiac disease such as diagnosed arrhythmias, on home oxygen, or end stage organ failure).
- Known history of poorly controlled diabetes or hypertension.
- Active neurological or psychiatric illnesses.
About this study
Official title: Home Based Covid-19 Rehabilitation Program: Pilot Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Covid-19
- Being tested
- PT-Pal, Self-guided exercises
- Keywords
- rehabilitative medicine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PT-PalBehavioural
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.
Self-guided exercisesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PT-Pal | Experimental | Participants randomized to the 14-day intervention arm will receive exercise instructions via PT-Pal. The Pt-Pal is a mobile health technology used to facilitate communication between the Care Team and patients, by allowing the team to send from their web-portal, exercise routines, surveys and educational material to the patient's mobile device. The PT-Pal app then captures the patient activity adherence, and reports those results back to the team including a graphical summary about patients' condition and activity. Clinicians can send/receive HIPAA-secure messages with patients. The app was designed to work with intermittent data connectivity typically found in mobile networks by switching between store-and-forward and real-time mode of connectivity to ensure data delivery. Receives: Behavioral: PT-Pal |
| Self-guided exercises | Active comparator | Participants randomized to the 14-day control arm will be instructed by research staff on how to use the exercise manual provided at the time of their screening. Receives: Behavioral: Self-guided exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pulmonary function (St George's Respiratory questionnaire: SGRQ)
The SGRQ is a valid instrument for measuring pulmonary function in patients with respiratory disease, with a total score and scores for symptom, physical activity, and impact domains (range 0 to 100; higher scores worse). The minimum clinically important difference is 4 points. The questionnaire has excellent reliability and validity compared to gold standard pulmonary function tests.
Measured: baseline, at day 7 and at day 14
Change in physical function (Activity Measure for Post-Acute Care: AM-PAC)
The AM-PAC was developed to examine basic mobility and daily activity functional activities important to adults. It is a validated measure of patient-reported functional limitation in 3 domains: basic mobility, daily activities, and applied cognition. It is endorsed by the National Quality Forum as a functional status quality metric.
Measured: baseline, at day 7 and at day 14
Secondary outcomes (8)
Change in pulmonary function (Sabrasez single breath count)
Patient asked to take a deep breath while at rest and to hold it (Normal >25 s). Test monitored by video (Zoom, PT-Pal).
Measured: baseline, at day 7 and at day 14
Change in pulmonary function (Peak flow tests)
Participants will be given a peak flow meter at recruitment, and taught how to use it by research staff over video.
Measured: baseline, at day 7 and at day 14
Change in physical function (5 times site to stand test)
This timed test assesses strength, balance and endurance. Test monitored by video (Zoom, PT-Pal).
Measured: baseline, at day 7 and at day 14
Health events (emergency room visits and hospitalizations)
Self-report or information from medical staff.
Measured: baseline to day 14
Change in psychological measures (Beck Anxiety Inventory: BAI)
Anxiety symptoms reported on the BAI. Higher scores indicate more anxiety.
Measured: baseline, at day 7 and at day 14
Change in psychological measures (Center for Epidemiologic Studies Depression Scale: CES-D)
Depressive symptoms reported on the CES-D. Higher score indicate more depressive symptoms.
Measured: baseline, at day 7 and at day 14
Feasibility (Adherence)
Number of sessions completed using app in the intervention arm. Controls periodically interviewed.
Measured: baseline to day 14
Feasibility (Acceptability)
Survey of satisfaction with exercise programs.
Measured: baseline to day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study startMay 2021 (estimated)
- Primary completionJan 2022 (estimated)
- Study completionMar 2022 (estimated)
Why it stopped: The study was never started due to recruitment difficulties. The rates of COVID infections in the recruitment area declined significantly.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Verghese, Albert Einstein College of Medicine
- Investigators
- Joe Verghese, MBBS, Principal investigator, Albert Einstein College of MedicineAnne F Ambrose, MD, Principal investigator, Albert Einstein College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406532
- Sponsor's protocol ID
- 2020-11535
- Status last verified
- Apr 2021
- First submitted
- 22 May 2020
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Based Covid-19 Rehabilitation Program: Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT04406532
- Acronym / sponsor ID
- 2020-11535
- Conditions
- Covid-19
- Keywords
- rehabilitative medicine
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was never started due to recruitment difficulties. The rates of COVID infections in the recruitment area declined significantly.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Study start
- May 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PT-Pal | Experimental | Behavioral: PT-PalParticipants randomized to the 14-day intervention arm will receive exercise instructions via PT-Pal. The Pt-Pal is a mobile health technology used to facilitate communication between the Care Team and patients, by allowing the team to send from their web-portal, exercise routines, surveys and educational material to the patient's mobile device. The PT-Pal app then captures the patient activity adherence, and reports those results back to the team including a graphical summary about patients' condition and activity. Clinicians can send/receive HIPAA-secure messages with patients. The app was designed to work with intermittent data connectivity typically found in mobile networks by switching between store-and-forward and real-time mode of connectivity to ensure data delivery. |
| Self-guided exercises | Active comparator | Behavioral: Self-guided exercisesParticipants randomized to the 14-day control arm will be instructed by research staff on how to use the exercise manual provided at the time of their screening. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 and older.
- Symptoms suggestive of Covid-19 infection (fever, cough, chest discomfort or loss of smell/taste).
- Covid-19 screening done.
- Ambulatory without assistive devices (such as cane or walker).
- Access to PT-Pal app via cellular phone, iPad or computer (e.g. Zoom™).
Key exclusion criteria (4 listed)
- Severe symptoms requiring referral to the Emergency Department.
- Contraindications to exercise (cardiac disease such as diagnosed arrhythmias, on home oxygen, or end stage organ failure).
- Known history of poorly controlled diabetes or hypertension.
- Active neurological or psychiatric illnesses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PT-PalParticipants 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. | Behavioural | PT-Pal |
| Self-guided exercisesParticipants 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. | Behavioural | Self-guided exercises |
Primary outcome
Change in pulmonary function (St George's Respiratory questionnaire: SGRQ)
Time frame: baseline, at day 7 and at day 14
The SGRQ is a valid instrument for measuring pulmonary function in patients with respiratory disease, with a total score and scores for symptom, physical activity, and impact domains (range 0 to 100; higher scores worse). The minimum clinically important difference is 4 points. The questionnaire has excellent reliability and validity compared to gold standard pulmonary function tests.
Change in physical function (Activity Measure for Post-Acute Care: AM-PAC)
Time frame: baseline, at day 7 and at day 14
The AM-PAC was developed to examine basic mobility and daily activity functional activities important to adults. It is a validated measure of patient-reported functional limitation in 3 domains: basic mobility, daily activities, and applied cognition. It is endorsed by the National Quality Forum as a functional status quality metric.
8 secondary outcomes
Change in pulmonary function (Sabrasez single breath count)
Time frame: baseline, at day 7 and at day 14
Change in pulmonary function (Peak flow tests)
Time frame: baseline, at day 7 and at day 14
Change in physical function (5 times site to stand test)
Time frame: baseline, at day 7 and at day 14
Health events (emergency room visits and hospitalizations)
Time frame: baseline to day 14
Change in psychological measures (Beck Anxiety Inventory: BAI)
Time frame: baseline, at day 7 and at day 14
Change in psychological measures (Center for Epidemiologic Studies Depression Scale: CES-D)
Time frame: baseline, at day 7 and at day 14
Feasibility (Adherence)
Time frame: baseline to day 14
Feasibility (Acceptability)
Time frame: baseline to day 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Verghese, MBBS principal investigator
Albert Einstein College of Medicine
Anne F Ambrose, MD principal investigator
Albert Einstein College of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing PT-Pal and Self-guided exercises in people with Covid-19, run by Albert Einstein College of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pulmonary function (St George's Respiratory questionnaire: SGRQ) (time frame: baseline, at day 7 and at day 14). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.