University of Colorado Hospital
Aurora, Colorado, 80045, United States
NCT Number: NCT04663945
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.
Looking for future studies?
Notify Me35 year–100 year
All sexes
Interventional
Not applicable
Aurora, Colorado, 80045, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biobehavioral tele-rehabilitation sessions
Time frame: 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: 6 weeks (primary end point)
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.
Time frame: Week 12
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to week 12
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Average Daily Step Count per week will be collected via a Fitbit activity monitor. Higher step counts indicate higher level of physical activity.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
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.
University of Colorado, Denver
Other
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID Survivors
Acronym: AFTER
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04794829
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial DetailsNCT07552779
COVID-19, COVID-19 (Coronavirus Disease 2019)
Brussels, Bruxelles-capitale, Région de, Belgium
View Trial DetailsNCT07722000
COVID-19, Chronic Disease
Banī Suwayf, Beni Suweif Governorate, Egypt
View Trial DetailsNCT04371432
COVID-19, Coronaviridae Infections
Bethesda, Maryland, United States
View Trial Details