Trial Outcomes & Findings for Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors (NCT NCT04663945)
NCT ID: NCT04663945
Last Updated: 2022-11-04
Results Overview
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.
COMPLETED
NA
49 participants
12 weeks
2022-11-04
Participant Flow
5 participants screen failed after enrolling, prior to starting the study.
Participant milestones
| Measure |
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
|
Control
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
15
|
|
Overall Study
Week 6 Evaluation
|
28
|
13
|
|
Overall Study
Week 12 Evaluation
|
28
|
12
|
|
Overall Study
COMPLETED
|
28
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Predictors of Recovery and the App-Facilitated Tele-Rehabilitation (AFTER) Program for COVID-19 Survivors
Baseline characteristics by cohort
| Measure |
Intervention
n=28 Participants
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
|
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 10 • n=93 Participants
|
54 years
STANDARD_DEVIATION 10 • n=4 Participants
|
52 years
STANDARD_DEVIATION 10 • n=27 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=93 Participants
|
13 participants
n=4 Participants
|
41 participants
n=27 Participants
|
|
30 Second Chair Stand Test
|
12 Completions
STANDARD_DEVIATION 3 • n=93 Participants
|
11 Completions
STANDARD_DEVIATION 3 • n=4 Participants
|
12 Completions
STANDARD_DEVIATION 3 • n=27 Participants
|
|
Timed Up-and-Go Test (TUG)
|
10 seconds
STANDARD_DEVIATION 3 • n=93 Participants
|
9 seconds
STANDARD_DEVIATION 3 • n=4 Participants
|
9 seconds
STANDARD_DEVIATION 3 • n=27 Participants
|
|
4-Stage Balance Test
|
37 scores on a scale
STANDARD_DEVIATION 5 • n=93 Participants
|
37 scores on a scale
STANDARD_DEVIATION 5 • n=4 Participants
|
37 scores on a scale
STANDARD_DEVIATION 5 • n=27 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Adherence was collected in the intervention group only.
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.
Outcome measures
| Measure |
Control
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Adherence (Primary Feasibility/Safety Outcome)
|
—
|
93 % of participants meeting adherence
Interval 77.0 to 99.0
|
PRIMARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
Change at Week 6
|
5.0 Completions
Interval 3.1 to 6.9
|
3.1 Completions
Interval 1.7 to 4.5
|
|
Change in 30 Second Chair Stand Test (Primary Efficacy Outcome)
Change at Week 12
|
5.1 Completions
Interval 3.2 to 7.0
|
3.2 Completions
Interval 1.8 to 4.6
|
SECONDARY outcome
Timeframe: 6 weeks (primary end point)Population: SUS was only collected on Intervention Group
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.
Outcome measures
| Measure |
Control
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=26 Participants
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
|
|---|---|---|
|
System Usability Scale (SUS)
|
—
|
72 score on a scale
Interval 61.0 to 75.0
|
SECONDARY outcome
Timeframe: Week 12The 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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Safety Event Count
Serious Adverse Events
|
1 Participants
|
0 Participants
|
|
Safety Event Count
Non-Serious Adverse Events
|
9 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Timed Up-and-Go Test (TUG)
Change at Week 6
|
-0.6 seconds
Interval -2.3 to 1.0
|
-1.7 seconds
Interval -2.9 to -0.5
|
|
Timed Up-and-Go Test (TUG)
Change at Week 12
|
-0.6 seconds
Interval -2.3 to 1.0
|
-1.9 seconds
Interval -3.1 to -0.7
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
4-Stage Balance Test
Change at Week 6
|
1.6 score on a scale
Interval -0.9 to 4.1
|
1.8 score on a scale
Interval -0.01 to 3.6
|
|
4-Stage Balance Test
Change at Week 12
|
2.7 score on a scale
Interval 0.3 to 5.2
|
2.9 score on a scale
Interval 1.1 to 4.7
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
MRC Dyspnea
Change at Week 6
|
-1.2 score on a scale
Interval -2.1 to -0.3
|
-1.3 score on a scale
Interval -2.0 to -0.7
|
|
MRC Dyspnea
Change at Week 12
|
-1.4 score on a scale
Interval -2.2 to -0.5
|
-1.5 score on a scale
Interval -2.1 to -0.8
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Activities-Specific Balance Confidence (ABC) Scale
Change at Week 6
|
11.3 score on a scale
Interval 1.6 to 21.1
|
7.1 score on a scale
Interval -0.2 to 14.3
|
|
Activities-Specific Balance Confidence (ABC) Scale
Change at Week 12
|
14.2 score on a scale
Interval 4.5 to 24.0
|
10.0 score on a scale
Interval 2.7 to 17.3
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Three-Item Loneliness Scale
Change at Week 6
|
0.3 score on a scale
Interval -0.6 to 1.2
|
-0.4 score on a scale
Interval -1.1 to 0.3
|
|
Three-Item Loneliness Scale
Change at Week 12
|
-0.1 score on a scale
Interval -1.1 to 0.8
|
-0.8 score on a scale
Interval -1.5 to -0.1
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a
Change at Week 6
|
-0.2 score on a scale
Interval -2.3 to 1.9
|
-0.3 score on a scale
Interval -1.9 to 1.3
|
|
PROMIS Short Form (SF) v1.0 General Self-Efficacy 4a
Change at Week 12
|
0.2 score on a scale
Interval -1.9 to 2.3
|
0.1 score on a scale
Interval -1.5 to 1.7
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions
Change at Week 6
|
2.7 score on a scale
Interval -2.0 to 7.5
|
2.2 score on a scale
Interval -1.4 to 5.8
|
|
PROMIS Short Form (SF) Self-Efficacy for Managing Chronic Conditions
Change at Week 12
|
4.4 score on a scale
Interval -0.4 to 9.2
|
3.9 score on a scale
Interval 0.2 to 7.5
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
PROMIS Scale v1.2 Global Health:
Change at Week 6
|
2.1 score on a scale
Interval -2.3 to 6.5
|
0.5 score on a scale
Interval -2.8 to 3.8
|
|
PROMIS Scale v1.2 Global Health:
Change at Week 12
|
4.6 score on a scale
Interval 0.1 to 9.0
|
3.0 score on a scale
Interval -0.3 to 6.3
|
SECONDARY outcome
Timeframe: Change from Baseline to week 12The 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.
Outcome measures
| Measure |
Control
n=12 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Montreal Cognitive Assessment (MoCA)-BLIND
|
0.5 score on a scale
Interval -0.7 to 1.6
|
1.1 score on a scale
Interval 0.3 to 2.0
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Clinical Frailty Scale
Change at Week 12
|
-0.7 score on a scale
Interval -1.2 to -0.2
|
-0.8 score on a scale
Interval -1.2 to -0.4
|
|
Clinical Frailty Scale
Change at Week 6
|
-0.4 score on a scale
Interval -0.9 to 0.2
|
-0.5 score on a scale
Interval -0.8 to -0.1
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: One participant in the control group did not complete week 12.
Average Daily Step Count per week will be collected via a Fitbit activity monitor. Higher step counts indicate higher level of physical activity.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=27 Participants
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
|
|---|---|---|
|
Average Daily Step Count
Change at Week 6
|
56 change in daily step count
Interval 44.0 to 69.0
|
56 change in daily step count
Interval 44.0 to 69.0
|
|
Average Daily Step Count
Change at Week 12
|
6 change in daily step count
Interval -6.0 to 18.0
|
6 change in daily step count
Interval -6.0 to 18.0
|
SECONDARY outcome
Timeframe: Change from Baseline to 6 weeks (primary end point), persisting at 12 weeksPopulation: The control group had one participant who did not complete week 12 testing.
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.
Outcome measures
| Measure |
Control
n=13 Participants
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
Intervention
n=28 Participants
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
|
|---|---|---|
|
Patient Health Questionnaire 8 (PHQ8)
Change at Week 6
|
-1.9 score on a scale
Interval -4.4 to 0.6
|
-3.8 score on a scale
Interval -5.8 to -1.8
|
|
Patient Health Questionnaire 8 (PHQ8)
Change at Week 12
|
-3.1 score on a scale
Interval -5.6 to -0.5
|
-5.0 score on a scale
Interval -7.0 to -2.9
|
Adverse Events
Intervention
Control
Serious adverse events
| Measure |
Intervention
n=29 participants at risk
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
|
Control
n=15 participants at risk
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
|---|---|---|
|
General disorders
Hospitalization
|
6.9%
2/29 • Number of events 2 • 12 Weeks
All safety events were categorized and counted and falls were graded according to the Falls-Grading Scale.
|
6.7%
1/15 • Number of events 1 • 12 Weeks
All safety events were categorized and counted and falls were graded according to the Falls-Grading Scale.
|
Other adverse events
| Measure |
Intervention
n=29 participants at risk
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
|
Control
n=15 participants at risk
This group will receive an activity monitor and basic education, but no individualized rehabilitation sessions or biobehavioral training.
Other: basic education
|
|---|---|---|
|
Injury, poisoning and procedural complications
Falls
|
0.00%
0/29 • 12 Weeks
All safety events were categorized and counted and falls were graded according to the Falls-Grading Scale.
|
40.0%
6/15 • Number of events 8 • 12 Weeks
All safety events were categorized and counted and falls were graded according to the Falls-Grading Scale.
|
Additional Information
Dr. Jennifer Stevens-Lapsley
University of Colorado Denver
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place