Clinical trial NCT04663945: Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
Official title: Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid-19
Deconditioning
Keywords: Tele-rehabilitation
High Intensity
Biobehavioral
Activity Self-Monitoring
Physical Functional Performance
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2020-12-11
Enrollment: 49
Sex: ALL
Minimum age (years): 35
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Adherence (Primary Feasibility/Safety Outcome)
timeFrame: 12 weeks
measure: Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary outcomes:
measure: System Usability Scale (SUS)
timeFrame: 6 weeks (primary end point)
measure: Safety Event Count
timeFrame: Week 12
measure: Timed Up-and-Go Test (TUG)
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: 4-Stage Balance Test
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: MRC Dyspnea
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: Activities-Specific Balance Confidence (ABC) Scale
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: Three-Item Loneliness Scale
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: PROMIS Scale v1.2 Global Health:
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: Montreal Cognitive Assessment (MoCA)-BLIND
timeFrame: Change from Baseline to week 12
measure: Clinical Frailty Scale
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: Average Daily Step Count
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
measure: Patient Health Questionnaire 8 (PHQ8)
timeFrame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Kristine Erlandson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.