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Trial - NCT04406532


Column Value
Trial registration number NCT04406532
Full text link
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

First author
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Joe Verghese, MBBS

Contact
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Emmeline Ayers, emmeline.ayers@einsteinmed.org (PI email not reported)

Registration date
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2020-05-28

Recruitment status
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Blind label

Center
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: 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. zoomâ„¢).

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

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.

Number of arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Albert Einstein College of Medicine

Inclusion age min
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Mild disease at enrollment

Severity scale
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

1: Mild disease at enrollment

Total sample size
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

Change in pulmonary function (St George's Respiratory questionnaire: SGRQ);Change in physical function (Activity Measure for Post-Acute Care: AM-PAC)

Notes
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : Oct. 26, 2020, 11:31 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 1039, "treatment_name": "Pt-pal (telephone-based app)", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1180, "treatment_name": "Self-guided exercises", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}]