Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors

NCT ID: NCT04663945

Last Updated: 2022-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-11

Study Completion Date

2021-12-27

Brief Summary

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The aim of this study is to investigate the feasibility (safety, adherence) and initial efficacy (physical function and patient reported outcomes) of a multicomponent tele-rehabilitation program during COVID-19 recovery of patients who have been hospitalized due to COVID-19.

Detailed Description

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The aim of this study is to investigate the feasibility and initial efficacy of a multicomponent tele-rehabilitation program during COVID-19 recovery. The tele-rehabilitation program will include biobehavioral training and high intensity exercise facilitated through an online application ('Platform'). Initial efficacy will be assessed primarily by performance on the 30" Chair Stand Test and secondarily through other physical function tests and patient reported outcome measures.

This study will advance the feasibility of tele-rehabilitation as a more generally useful intervention in patients lacking access (distance, availability, mobility) to standard rehabilitative services and could transform the way in which acute rehabilitation and post-hospital care is delivered for all patients.

Conditions

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Covid-19 Deconditioning

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

This group will receive 12 biobehaviorally informed tele-rehabilitation sessions including high-intensity strengthening; sessions will be delivered by a licensed physical therapist. An application ('Platform') will facilitate home exercise program completion outside of the supervised sessions.

Other: remote controlled exercise plus home exercise

Treatments: strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise

Group Type EXPERIMENTAL

Biobehavioral Tele-rehabilitation Sessions

Intervention Type BEHAVIORAL

Biobehavioral tele-rehabilitation sessions

Control

This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.

Other: basic education

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Biobehavioral Tele-rehabilitation Sessions

Biobehavioral tele-rehabilitation sessions

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Confirmed COVID-19, per diagnostic criteria (PCR testing)
2. Hospitalized for at least 24 hours
3. Able to provide informed consent
4. Internet capability to access the platform
5. Community-dwelling prior to hospitalization

Exclusion Criteria

1. Unstable medical comorbidities that would preclude participation in exercise
2. Receipt of \>1 session of outpatient physical therapy
3. Known pregnancy, as the impact on physical function, pulmonary function, and other outcomes will vary well beyond any expected effects of COVID-19
4. Anticipating concurrent additional physical therapy services during study intervention period (12 weeks)
Minimum Eligible Age

35 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kristine Erlandson, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Hospital

Aurora, Colorado, United States

Site Status

Countries

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United States

References

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Churchill L, Morrow M, Capin JJ, Jolley SE, Hare K, MaWhinney S, Stevens-Lapsley JE, Erlandson KM. Using Wearable Technology to Quantify Physical Activity Recovery: Secondary Report From the AFTER (App-Facilitated Tele-Rehabilitation) Program for COVID-19 Survivors Randomized Study. JMIR Rehabil Assist Technol. 2023 Mar 20;10:e43436. doi: 10.2196/43436.

Reference Type DERIVED
PMID: 36939818 (View on PubMed)

Capin JJ, Jolley SE, Morrow M, Connors M, Hare K, MaWhinney S, Nordon-Craft A, Rauzi M, Flynn S, Stevens-Lapsley JE, Erlandson KM. Safety, feasibility and initial efficacy of an app-facilitated telerehabilitation (AFTER) programme for COVID-19 survivors: a pilot randomised study. BMJ Open. 2022 Jul 26;12(7):e061285. doi: 10.1136/bmjopen-2022-061285.

Reference Type DERIVED
PMID: 35882451 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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20-2415

Identifier Type: -

Identifier Source: org_study_id

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