Covid-19, Deconditioning
Conditions
Keywords
Tele-rehabilitation, High Intensity, Biobehavioral, Activity Self-Monitoring, Physical Functional Performance
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.
Interventions
BEHAVIORALBiobehavioral Tele-rehabilitation Sessions
Biobehavioral tele-rehabilitation sessions
Sponsors
National Institute on Aging (NIA)
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 100 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adherence (Primary Feasibility/Safety Outcome) | 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. |
| Change in 30 Second Chair Stand Test (Primary Efficacy Outcome) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up-and-Go Test (TUG) | 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. |
| 4-Stage Balance Test | 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. |
| MRC Dyspnea | 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 |
| Activities-Specific Balance Confidence (ABC) Scale | 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. |
| Three-Item Loneliness Scale | 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. |
| PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a | 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. |
| System Usability Scale (SUS) | 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. |
| PROMIS Scale v1.2 Global Health: | 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. |
| Montreal Cognitive Assessment (MoCA)-BLIND | 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. |
| Clinical Frailty Scale | 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. |
| Average Daily Step Count | 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. |
| Patient Health Questionnaire 8 (PHQ8) | 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. |
| PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions | 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. |
| Safety Event Count | 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. |
Countries
United States
Participant flow
Pre-assignment details
5 participants screen failed after enrolling, prior to starting the study.
Participants by arm
| Arm | Count |
|---|---|
| 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
Biobehavioral Tele-rehabilitation Sessions: Biobehavioral tele-rehabilitation sessions | 28 |
| Control This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education | 13 |
| Total | 41 |
Baseline characteristics
| Characteristic | Total | Control | Intervention |
|---|---|---|---|
| 30 Second Chair Stand Test | 12 Completions STANDARD_DEVIATION 3 | 11 Completions STANDARD_DEVIATION 3 | 12 Completions STANDARD_DEVIATION 3 |
| 4-Stage Balance Test | 37 scores on a scale STANDARD_DEVIATION 5 | 37 scores on a scale STANDARD_DEVIATION 5 | 37 scores on a scale STANDARD_DEVIATION 5 |
| Age, Continuous | 52 years STANDARD_DEVIATION 10 | 54 years STANDARD_DEVIATION 10 | 52 years STANDARD_DEVIATION 10 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 6 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants | 7 Participants | 22 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 24 Participants | 7 Participants | 17 Participants |
| Region of Enrollment United States | 41 participants | 13 participants | 28 participants |
| Sex: Female, Male Female | 18 Participants | 5 Participants | 13 Participants |
| Sex: Female, Male Male | 23 Participants | 8 Participants | 15 Participants |
| Timed Up-and-Go Test (TUG) | 9 seconds STANDARD_DEVIATION 3 | 9 seconds STANDARD_DEVIATION 3 | 10 seconds STANDARD_DEVIATION 3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 15 |
| other Total, other adverse events | 0 / 29 | 6 / 15 |
| serious Total, serious adverse events | 2 / 29 | 1 / 15 |
Outcome results
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.
Time frame: 12 weeks
Population: Adherence was collected in the intervention group only.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Adherence (Primary Feasibility/Safety Outcome) | 93 % of participants meeting adherence |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Change in 30 Second Chair Stand Test (Primary Efficacy Outcome) | Change at Week 6 | 3.1 Completions |
| Intervention | Change in 30 Second Chair Stand Test (Primary Efficacy Outcome) | Change at Week 12 | 3.2 Completions |
| Control | Change in 30 Second Chair Stand Test (Primary Efficacy Outcome) | Change at Week 6 | 5.0 Completions |
| Control | Change in 30 Second Chair Stand Test (Primary Efficacy Outcome) | Change at Week 12 | 5.1 Completions |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | 4-Stage Balance Test | Change at Week 6 | 1.8 score on a scale |
| Intervention | 4-Stage Balance Test | Change at Week 12 | 2.9 score on a scale |
| Control | 4-Stage Balance Test | Change at Week 12 | 2.7 score on a scale |
| Control | 4-Stage Balance Test | Change at Week 6 | 1.6 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Activities-Specific Balance Confidence (ABC) Scale | Change at Week 6 | 7.1 score on a scale |
| Intervention | Activities-Specific Balance Confidence (ABC) Scale | Change at Week 12 | 10.0 score on a scale |
| Control | Activities-Specific Balance Confidence (ABC) Scale | Change at Week 6 | 11.3 score on a scale |
| Control | Activities-Specific Balance Confidence (ABC) Scale | Change at Week 12 | 14.2 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: One participant in the control group did not complete week 12.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Average Daily Step Count | Change at Week 6 | 56 change in daily step count |
| Intervention | Average Daily Step Count | Change at Week 12 | 6 change in daily step count |
| Control | Average Daily Step Count | Change at Week 6 | 56 change in daily step count |
| Control | Average Daily Step Count | Change at Week 12 | 6 change in daily step count |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Clinical Frailty Scale | Change at Week 6 | -0.5 score on a scale |
| Intervention | Clinical Frailty Scale | Change at Week 12 | -0.8 score on a scale |
| Control | Clinical Frailty Scale | Change at Week 6 | -0.4 score on a scale |
| Control | Clinical Frailty Scale | Change at Week 12 | -0.7 score on a scale |
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.
Time frame: Change from Baseline to week 12
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Montreal Cognitive Assessment (MoCA)-BLIND | 1.1 score on a scale |
| Control | Montreal Cognitive Assessment (MoCA)-BLIND | 0.5 score on a scale |
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
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | MRC Dyspnea | Change at Week 12 | -1.5 score on a scale |
| Intervention | MRC Dyspnea | Change at Week 6 | -1.3 score on a scale |
| Control | MRC Dyspnea | Change at Week 12 | -1.4 score on a scale |
| Control | MRC Dyspnea | Change at Week 6 | -1.2 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Patient Health Questionnaire 8 (PHQ8) | Change at Week 6 | -3.8 score on a scale |
| Intervention | Patient Health Questionnaire 8 (PHQ8) | Change at Week 12 | -5.0 score on a scale |
| Control | Patient Health Questionnaire 8 (PHQ8) | Change at Week 6 | -1.9 score on a scale |
| Control | Patient Health Questionnaire 8 (PHQ8) | Change at Week 12 | -3.1 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | PROMIS Scale v1.2 Global Health: | Change at Week 6 | 0.5 score on a scale |
| Intervention | PROMIS Scale v1.2 Global Health: | Change at Week 12 | 3.0 score on a scale |
| Control | PROMIS Scale v1.2 Global Health: | Change at Week 6 | 2.1 score on a scale |
| Control | PROMIS Scale v1.2 Global Health: | Change at Week 12 | 4.6 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions | Change at Week 6 | 2.2 score on a scale |
| Intervention | PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions | Change at Week 12 | 3.9 score on a scale |
| Control | PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions | Change at Week 6 | 2.7 score on a scale |
| Control | PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions | Change at Week 12 | 4.4 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a | Change at Week 6 | -0.3 score on a scale |
| Intervention | PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a | Change at Week 12 | 0.1 score on a scale |
| Control | PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a | Change at Week 6 | -0.2 score on a scale |
| Control | PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a | Change at Week 12 | 0.2 score on a scale |
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.
Time frame: Week 12
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Safety Event Count | Serious Adverse Events | 0 Participants |
| Intervention | Safety Event Count | Non-Serious Adverse Events | 11 Participants |
| Control | Safety Event Count | Serious Adverse Events | 1 Participants |
| Control | Safety Event Count | Non-Serious Adverse Events | 9 Participants |
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.
Time frame: 6 weeks (primary end point)
Population: SUS was only collected on Intervention Group
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Intervention | System Usability Scale (SUS) | 72 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Three-Item Loneliness Scale | Change at Week 6 | -0.4 score on a scale |
| Intervention | Three-Item Loneliness Scale | Change at Week 12 | -0.8 score on a scale |
| Control | Three-Item Loneliness Scale | Change at Week 6 | 0.3 score on a scale |
| Control | Three-Item Loneliness Scale | Change at Week 12 | -0.1 score on a scale |
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.
Time frame: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeks
Population: The control group had one participant who did not complete week 12 testing.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Timed Up-and-Go Test (TUG) | Change at Week 6 | -1.7 seconds |
| Intervention | Timed Up-and-Go Test (TUG) | Change at Week 12 | -1.9 seconds |
| Control | Timed Up-and-Go Test (TUG) | Change at Week 6 | -0.6 seconds |
| Control | Timed Up-and-Go Test (TUG) | Change at Week 12 | -0.6 seconds |