Trial Outcomes & Findings for The Impact of a Home-based Pulmonary Telerehabilitation Program in Acute Exacerbations of COPD (NCT NCT03997513)
NCT ID: NCT03997513
Last Updated: 2024-07-05
Results Overview
Quadriceps muscle maximal force (kilogram-force, kgf) will be measured with a Keiser leg press. One repetition maximum (1RM) measures will be obtained by progressively increasing resistance until the participant is unable to successfully complete one repetition. Peak muscle power will be measured at 40, 50, 60, 70, 80, and 90 percent of the 1RM 30 minutes after the 1RM measurement was obtained.
COMPLETED
NA
5 participants
measured at baseline and at ten weeks
2024-07-05
Participant Flow
Participant milestones
| Measure |
Pulmonary Telerehabilitation Intervention Group
The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
Pulmonary Telerehabilitation: The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
|
Usual Care Group
Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.
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|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Impact of a Home-based Pulmonary Telerehabilitation Program in Acute Exacerbations of COPD
Baseline characteristics by cohort
| Measure |
Pulmonary Telerehabilitation Intervention Group
n=2 Participants
The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
Pulmonary Telerehabilitation: The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
|
Usual Care Group
n=3 Participants
Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.
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Total
n=5 Participants
Total of all reporting groups
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|---|---|---|---|
|
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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
68 years
n=5 Participants
|
71 years
n=7 Participants
|
71 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 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
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 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
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: measured at baseline and at ten weeksPopulation: This test was not performed due to COVID restrictions at the VA and inability to use the testing equipment.
Quadriceps muscle maximal force (kilogram-force, kgf) will be measured with a Keiser leg press. One repetition maximum (1RM) measures will be obtained by progressively increasing resistance until the participant is unable to successfully complete one repetition. Peak muscle power will be measured at 40, 50, 60, 70, 80, and 90 percent of the 1RM 30 minutes after the 1RM measurement was obtained.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: measured at baseline and at ten weeksPopulation: One participant in the intervention group declined six minute walk testing at the baseline and follow-up visit. The difference in walk distance from baseline to 10 weeks was compared between groups.
Participants completed a six minute walk test, which consisted of walking in a flat corridor for six minutes with the distance walked measured in feet. Participants were instructed to complete the walk using their home oxygen prescription for exertion. The difference between baseline and ten week walk test was compared between groups.
Outcome measures
| Measure |
Pulmonary Telerehabilitation Intervention Group
n=1 Participants
The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
Pulmonary Telerehabilitation: The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
|
Usual Care Group
n=2 Participants
Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.
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|---|---|---|
|
Six Minute Walk Test
|
472 feet
|
48.25 feet
Standard Deviation 549.07
|
PRIMARY outcome
Timeframe: measured at baseline and ten weeksPopulation: This questionnaire was not used.
Health-related quality of life will be assessed with the Short-Form 36-Item Questionnaire (SF-36) prior to hospital discharge and at ten weeks following an eight week pulmonary telerehabilitation intervention or usual care. The SF-36 consists of 36 questions spanning nine health domains and is a valid measure of health-related quality of life in COPD that is responsive to change following a pulmonary rehabilitation intervention.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: measured at ten weeks (study completion)Population: Participants randomized to the pulmonary telerehabilitation intervention group
Participants will be administered a survey by the study coordinator at ten weeks after completion of the eight-week pulmonary telerehabilitation intervention that will require them to respond to statements related to their satisfaction with the home-based program. Statements will address ease of use of the video conferencing modality, acceptability of exercise components, perceptions of impact on muscle strength and exercise endurance, and willingness to participate in additional pulmonary telerehabilitation. Participants randomized to the usual care group will not be administered a survey.
Outcome measures
| Measure |
Pulmonary Telerehabilitation Intervention Group
n=2 Participants
The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
Pulmonary Telerehabilitation: The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
|
Usual Care Group
Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.
|
|---|---|---|
|
Participant Satisfaction Survey
Participants reporting that exercise sessions were acceptable
|
2 Participants
|
—
|
|
Participant Satisfaction Survey
Participants reporting tablet interface was easy to navigate once they received instruction on use
|
2 Participants
|
—
|
|
Participant Satisfaction Survey
Participants reporting adverse events
|
0 Participants
|
—
|
|
Participant Satisfaction Survey
Participants reporting tolerating exercise well
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: measured at baseline and ten weeksPopulation: the change in sit to stand count in 30 seconds from baseline to ten weeks between the intervention and usual care group were compared
The one-minute sit-to-stand test has been shown to be reliable, valid, and responsive to change in exercise capacity following pulmonary rehabilitation in individuals with COPD. The test consists of the participant standing at full leg extension from a sitting position at their own pace as often as possible during a one minute testing interval. The participant is permitted to stop at any time during the one minute interval if necessary. An armless chair is used for testing and the participant is asked to fold their arms across their chest during testing. Two tests will be performed on separate days prior to discharge and the test with the greatest number of repetitions will be used as the baseline performance measure. A third test will be performed at ten weeks following an eight week pulmonary telerehabilitation intervention or usual care.
Outcome measures
| Measure |
Pulmonary Telerehabilitation Intervention Group
n=2 Participants
The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
Pulmonary Telerehabilitation: The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
|
Usual Care Group
n=2 Participants
Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.
|
|---|---|---|
|
Sit-to-stand Test Change
|
9.5 repetitions
Standard Deviation 6.4
|
5 repetitions
Standard Deviation 1.4
|
SECONDARY outcome
Timeframe: measured at baseline and ten weeksPopulation: change in handgrip strength from baseline to ten weeks compared between groups
Handgrip strength of the dominant hand will be measured with a hand dynamometer. Three measurements will be taken with a 60 second recovery period between trials. The average maximal force across trials will be calculated as the final handgrip strength.
Outcome measures
| Measure |
Pulmonary Telerehabilitation Intervention Group
n=2 Participants
The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
Pulmonary Telerehabilitation: The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
|
Usual Care Group
n=2 Participants
Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.
|
|---|---|---|
|
Handgrip Strength
|
1.75 Kg
Standard Deviation 3.18
|
0.5 Kg
Standard Deviation 12.02
|
SECONDARY outcome
Timeframe: measured at baseline and ten weeksPopulation: change in SGRQ score from baseline to ten weeks compared between groups
The St. George's Respiratory Questionnaire (SGRQ) is a disease-specific questionnaire validated to measure health status in patients with COPD. Total SGRQ scores range from 0-100 with higher scores indicating greater symptoms burden. The minimal clinically important difference is a difference of four points in the total SGRQ score.
Outcome measures
| Measure |
Pulmonary Telerehabilitation Intervention Group
n=2 Participants
The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
Pulmonary Telerehabilitation: The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
|
Usual Care Group
n=2 Participants
Participants randomized to the usual care arm will also be enrolled in our institution's telehealth program, will receive an automatic blood pressure monitor, portable pulse oximeter, and scale and will be in regular contact with a telehealth provider. A study team member will meet with participants randomized to the usual care arm to discuss the importance of exercise and will encourage exercise (strength training, light aerobic activity such as walking or cycling) a minimum of 20-40 minutes three times per week at discharge.
|
|---|---|---|
|
Disease Specific Quality of Life
|
-.19 score on a scale
Standard Deviation 20.9
|
-17.8 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: measured at baseline and ten weeksPopulation: not systematically assessed during the study
The participants' perception of dyspnea and exertion during the sit-to-stand test will be assessed following each test with the ten point Borg dyspnea and leg fatigue scale, which measures the degree of dyspnea and leg fatigue with exercise.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: measured at ten weeks (study completion)Population: Not administered.
Questions regarding social support, psychiatric attributes, and other factors potentially associated with program adherence will be asked in order to gain preliminary insights to optimize recruitment for a larger, randomized controlled trial of pulmonary telerehabilitation.
Outcome measures
Outcome data not reported
Adverse Events
Pulmonary Telerehabilitation Intervention Group
Usual Care Group
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