Trial Outcomes & Findings for Smart Telehealth Exercise Intervention to Reduce COPD Readmissions (NCT NCT03089853)
NCT ID: NCT03089853
Last Updated: 2022-03-22
Results Overview
The primary outcome is the rate of all-cause readmissions within 30 days following an index hospitalization for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
COMPLETED
NA
7 participants
Up to Day 30
2022-03-22
Participant Flow
Participant milestones
| Measure |
Intervention Arm
Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
|
Usual Care Arm
Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Intervention Arm
Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
|
Usual Care Arm
Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Smart Telehealth Exercise Intervention to Reduce COPD Readmissions
Baseline characteristics by cohort
| Measure |
Intervention Arm
n=4 Participants
Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
|
Usual Care Arm
n=3 Participants
Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Continuous
|
59.8 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Day 30Population: We were unable to analyse because of the small sample size.
The primary outcome is the rate of all-cause readmissions within 30 days following an index hospitalization for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
Outcome measures
| Measure |
Intervention Arm
n=4 Participants
Subjects randomized to intervention arm will have a device applied to their thigh on either side, and subject to neuromuscular electrical stimulation for 30 minutes daily for 2 weeks, followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
|
Usual Care Arm
n=3 Participants
Usual care will consist of a protocolized regimen of 5 days of systemic steroids, unless the treating physician determines a different regimen, in which case the change will be documented.
|
|---|---|---|
|
Rate of All-cause Readmissions
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
This outcome will be measured using spirometry.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
mMRC scale is a five-point scale originally published in 1959 that considers certain activities, such as walking or climbing stairs, which provoke breathlessness.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
SOBQ is a self-administered questionnaire to rate the level of dyspnea associated with activities of daily living. The minimum clinically important difference (MCID) if 5 units.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
CAT is a self-administered questionnaire where a change of 2 units is considered clinically significant.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
Measured using a dynamometer in pounds/kilograms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
Scores range from 4 to 14, depending on age and sex. Higher scores indicate higher levels of functioning. MCID is 2.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
Blood levels of C-Reactive Protein (CRP), Fibrinogen, Interleukin 6 (IL-6) and Tumour Necrosis Factor alpha (TNF-alpha)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: We were unable to analyse because of the small sample size.
Pro-inflammatory signaling in quadriceps skeletal muscle
Outcome measures
Outcome data not reported
Adverse Events
Intervention Arm
Usual Care Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place