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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Completed

Conditions

Deconditioning
Covid-19

Treatments

Behavioral: Biobehavioral Tele-rehabilitation Sessions

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04663945
20-2415

Details and patient eligibility

About

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.

Full description

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.

Enrollment

49 patients

Sex

All

Ages

35 to 100 years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

49 participants in 2 patient groups

Intervention
Experimental group
Description:
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
Treatment:
Behavioral: Biobehavioral Tele-rehabilitation Sessions
Control
No Intervention group
Description:
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training. Other: basic education

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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