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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04663945
Other study ID # 20-2415
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 11, 2020
Est. completion date December 27, 2021

Study information

Verified date October 2022
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 49
Est. completion date December 27, 2021
Est. primary completion date August 12, 2021
Accepts healthy volunteers No
Gender All
Age group 35 Years to 100 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Biobehavioral Tele-rehabilitation Sessions
Biobehavioral tele-rehabilitation sessions

Locations

Country Name City State
United States University of Colorado Hospital Aurora Colorado

Sponsors (2)

Lead Sponsor Collaborator
University of Colorado, Denver National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adherence (Primary Feasibility/Safety Outcome) Feasibility will be measured by program adherence, defined as the number of sessions attended divided by the total number of prescribed sessions (n=12). Individuals will be considered adherent if they attend at least 75% (n=9) of the total sessions. Adherence will be collected in the intervention group only. 12 weeks
Primary Change in 30 Second Chair Stand Test (Primary Efficacy Outcome) The test uses a standard height chair and requires the participant to stand up and sit down as many times as possible in 30 seconds. More completions indicate better physical function. To facilitate accuracy of the test over video, the participant will be instructed to count out loud each time he/she stands. Further, the test will also be facilitated by the Platform. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary System Usability Scale (SUS) The SUS is a 10-item survey that uses a 5-point Likert scale (Strongly disagree (1) to Strongly agree (5)). Scores range from 0 to 100 and higher scores indicate better usability. The SUS will be collected in the intervention group only. 6 weeks (primary end point)
Secondary Safety Event Count The Safety Event Count is the cumulative number of participants who experienced adverse events and severe adverse events counted from baseline to week 12. Events will be categorized by type. Week 12
Secondary Timed Up-and-Go Test (TUG) The TUG test measures the time it takes for a person to rise from a chair, walk 3 meters, turn around, walk back to the chair, and sit down. Participants will complete the TUG test twice and the best time will be used. Faster times indicate better physical function and lower risk of falls. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary 4-Stage Balance Test The 4-stage balance test measures static balance in 4 different positions (narrow base of support, semi-tandem, tandem, and single-leg). The test is facilitated by the Platform; it requires participants to hold each position for up to 10 seconds. If a participant is unable to hold a position for 10 seconds, the next hardest position is not performed. Completing higher levels indicate lesser fall risk and better balance. Total scores range from 0 to 40, with higher scores indicating better outcomes. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary MRC Dyspnea The MRC dyspnea scale is an interviewer-administered or self-report assessment of the perception of difficulty breathing during five different tasks. Participants respond either yes or no to each task. Score is the sum of the number of Yes answers, 0-5. Higher numbers indicate more difficulty breathing Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary Activities-Specific Balance Confidence (ABC) Scale The ABC Scale is a 16-item self-report measure of balance confidence in performing activities without losing balance or experiencing a sense of unsteadiness. Score range: 0-100. Higher scores indicate higher confidence in performing activities without losing balance. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary Three-Item Loneliness Scale This scale has three items and a simplified set of response categories that is designed to measure overall loneliness. Score range: 3-9. Higher scores indicate higher loneliness. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a The PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a consists of 4 items rated on a 5-point Likert scale (not at all confident (1) to very confident (5)); values range from 4-20. Higher scores indicate higher levels of general self-efficacy. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions The PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions is an 8-item scale rated on a 5-point Likert scale;values range from 8-32. Higher scores indicate higher levels of self confidence in one's ability to successfully perform specific tasks or behaviors related to one's health in a variety of situations. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary PROMIS Scale v1.2 Global Health: The PROMIS Scale v1.2 Global Health measures quality of life on two domains: physical and mental health. Raw values for each domain range from 4 - 20; scores are converted to a t-score with a mean of 50 and SD of 10. Higher scores indicate better health. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary Montreal Cognitive Assessment (MoCA)-BLIND The MoCA-BLIND assesses different cognitive domains: attention, concentration, memory, language, conceptual thinking, calculations, and orientation. The MoCA-BLIND has removed assessments requiring vision, thus can be completed using telehealth or telephone assessments. Score range: 0-22, with 18-22 normal range. Change from Baseline to week 12
Secondary Clinical Frailty Scale The Clinical Frailty scale is a self-report scale to estimate function. The participant selects perceived level of function prior to and following admission ranging from very active to bedridden/terminal. Score range: 1 (very fit) - 9 (terminally ill), with higher scores indicating higher levels of frailty. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary Average Daily Step Count Average Daily Step Count per week will be collected via a Fitbit activity monitor. Higher step counts indicate higher level of physical activity. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Secondary Patient Health Questionnaire 8 (PHQ8) The Patient Health Questionnaire 8 measures severity of depressive symptoms over the past 2 weeks. The 8 item scale is rated on a 4 point scale (not at all to nearly every day). Score range: 0-24. Higher scores indicate more severe depressive symptoms. Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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