Covid-19 Clinical Trial
Official title:
Home Based Covid-19 Rehabilitation Program: Pilot Clinical Trial
NCT number | NCT04406532 |
Other study ID # | 2020-11535 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | May 2021 |
Est. completion date | March 2022 |
Verified date | April 2021 |
Source | Albert Einstein College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2022 |
Est. primary completion date | January 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. Zoomâ„¢). 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | baseline, at day 7 and at day 14 | |
Primary | 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. | baseline, at day 7 and at day 14 | |
Secondary | 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). | baseline, at day 7 and at day 14 | |
Secondary | 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. | baseline, at day 7 and at day 14 | |
Secondary | 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). | baseline, at day 7 and at day 14 | |
Secondary | Health events (emergency room visits and hospitalizations) | Self-report or information from medical staff. | baseline to day 14 | |
Secondary | Change in psychological measures (Beck Anxiety Inventory: BAI) | Anxiety symptoms reported on the BAI. Higher scores indicate more anxiety. | baseline, at day 7 and at day 14 | |
Secondary | 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. | baseline, at day 7 and at day 14 | |
Secondary | Feasibility (Adherence) | Number of sessions completed using app in the intervention arm. Controls periodically interviewed. | baseline to day 14 | |
Secondary | Feasibility (Acceptability) | Survey of satisfaction with exercise programs. | baseline to day 14 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT06065033 -
Exercise Interventions in Post-acute Sequelae of Covid-19
|
N/A | |
Completed |
NCT06267534 -
Mindfulness-based Mobile Applications Program
|
N/A | |
Completed |
NCT05047601 -
A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection
|
Phase 2/Phase 3 | |
Recruiting |
NCT05323760 -
Functional Capacity in Patients Post Mild COVID-19
|
N/A | |
Recruiting |
NCT04481633 -
Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection
|
N/A | |
Completed |
NCT04537949 -
A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults
|
Phase 1/Phase 2 | |
Completed |
NCT04612972 -
Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru
|
Phase 3 | |
Recruiting |
NCT05494424 -
Cognitive Rehabilitation in Post-COVID-19 Condition
|
N/A | |
Active, not recruiting |
NCT06039449 -
A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2
|
Phase 3 | |
Enrolling by invitation |
NCT05589376 -
You and Me Healthy
|
||
Completed |
NCT05158816 -
Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
|
||
Recruiting |
NCT04341506 -
Non-contact ECG Sensor System for COVID19
|
||
Completed |
NCT04512079 -
FREEDOM COVID-19 Anticoagulation Strategy
|
Phase 4 | |
Completed |
NCT04384445 -
Zofin (Organicell Flow) for Patients With COVID-19
|
Phase 1/Phase 2 | |
Completed |
NCT05975060 -
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT05542862 -
Booster Study of SpikoGen COVID-19 Vaccine
|
Phase 3 | |
Withdrawn |
NCT05621967 -
Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation
|
N/A | |
Terminated |
NCT05487040 -
A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease
|
Phase 1 | |
Terminated |
NCT04498273 -
COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80
|
Phase 3 | |
Active, not recruiting |
NCT06033560 -
The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure
|