Home-Based Covid-19 Rehabilitation Program

NCT04406532 | Withdrawn DMC

• 1 other identifier: 2020-11535
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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 tested for COVID-19 infection and isolated at home.

Conditions

Covid-19

Keywords

rehabilitative medicine

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Change in pulmonary function (Sabrasez single breath count)

  baseline, at day 7 and at day 14

• Change in pulmonary function (Peak flow tests)

  baseline, at day 7 and at day 14

• Change in physical function (5 times site to stand test)

  baseline, at day 7 and at day 14

• Health events (emergency room visits and hospitalizations)

  baseline to day 14

• Change in psychological measures (Beck Anxiety Inventory: BAI)

  baseline, at day 7 and at day 14

Study Arms (2)

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.

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.

Behavioral: Self-guided exercises

Interventions

PT-Pal BEHAVIORAL

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.

PT-Pal

Self-guided exercises BEHAVIORAL

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.

Self-guided exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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™).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Joe Verghese, MBBS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• Anne F Ambrose, MD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 28, 2020
• Study Start: May 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: March 1, 2022
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share