RESP-FIT: Technology-Enhanced Self-Management in COPD
| Status: | Recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - Any |
| Updated: | 8/31/2018 |
| Start Date: | January 18, 2018 |
| End Date: | July 31, 2019 |
| Contact: | Sarah Miller, PhD, RN |
| Email: | millesar@musc.edu |
| Phone: | 843-7921692 |
30 adults, aged 40 and older with mild to moderate COPD, will be recruited for this study.
Participants must be willing to continually wear a FitBit activity monitor, have access to a
smartphone or Wi-Fi/Data-enabled iPad, and be willing to complete respiratory muscle strength
training exercises as well as reports on their smartphone at least 5 times per week for a
6-week period. Participants will be given a bluetooth inhaler device and a training app
(RESP-FIT). This application will collect inhaler data and allows patients to self-report
their daily symptoms. The goal of this study is to test whether use of the personalized
inhaler device with the app strengthens lung function, promotes physical activity, and
improves disease symptom self-management in persons with COPD.
Participants must be willing to continually wear a FitBit activity monitor, have access to a
smartphone or Wi-Fi/Data-enabled iPad, and be willing to complete respiratory muscle strength
training exercises as well as reports on their smartphone at least 5 times per week for a
6-week period. Participants will be given a bluetooth inhaler device and a training app
(RESP-FIT). This application will collect inhaler data and allows patients to self-report
their daily symptoms. The goal of this study is to test whether use of the personalized
inhaler device with the app strengthens lung function, promotes physical activity, and
improves disease symptom self-management in persons with COPD.
RESP-FIT. The RESP-FIT program is a 6-week respiratory muscle strength training intervention
adapted from previous respiratory muscle strength training (RMST) training regimens,
consisting of 1) five training days/week using combined inspiratory and expiratory muscle
training, consisting of breathing in and out against a combine inspiratory and expiratory
muscle strength trainer (IMST/EMST), 2) individualized, progress-based text message training
reminders and prompts related to timing and intensification calibration, and 3) use of a
Fitbit for remote monitoring of physical activity and hours slept at night. Similar to other
muscle strength training programs, exercises are done at regular intervals during the week (5
breaths, 5 times a day, 5 days a week; the participant will receive graphical illustration of
RESP-FIT training frequency and intensity achieved, and based on their training regimen, will
be prompted and/or reinforced via SMS text messaging). As the use of an accelerometer or
remote tracking device alone may affect physical activity, a control group will receive only
the Fitbit. This study proposes to assess the feasibility and initial efficacy of RMST by
obtaining estimates of variability in fatigue secondary to dyspnea, using a
technologically-enhanced RESP-FIT intervention. Our overarching hypothesis is that a training
regimen consisting of RMST along with technology-enhanced symptom-tracking will decrease
dyspnea, dyspnea-related activity avoidance, and fatigue. Additionally, this application
proposes to further develop Smartphone Airway Monitoring System (SAMS) which currently
integrates EMA probe questions covering COPD symptoms and preventive care use with the new
functions, use in an adult population with COPD, video captured training technique and
logging of RMST training sessions. Up to thirty adults with COPD (age over 40) will complete
the study and use the SAMS app for 6 weeks in the natural environment. We will evaluate the
acceptability, feasibility, adherence, and performance of RESP-FIT + SAMS through
quantitative methods to further optimize the app and related study procedures for the next
phase of testing (i.e., large scale efficacy RCT).
adapted from previous respiratory muscle strength training (RMST) training regimens,
consisting of 1) five training days/week using combined inspiratory and expiratory muscle
training, consisting of breathing in and out against a combine inspiratory and expiratory
muscle strength trainer (IMST/EMST), 2) individualized, progress-based text message training
reminders and prompts related to timing and intensification calibration, and 3) use of a
Fitbit for remote monitoring of physical activity and hours slept at night. Similar to other
muscle strength training programs, exercises are done at regular intervals during the week (5
breaths, 5 times a day, 5 days a week; the participant will receive graphical illustration of
RESP-FIT training frequency and intensity achieved, and based on their training regimen, will
be prompted and/or reinforced via SMS text messaging). As the use of an accelerometer or
remote tracking device alone may affect physical activity, a control group will receive only
the Fitbit. This study proposes to assess the feasibility and initial efficacy of RMST by
obtaining estimates of variability in fatigue secondary to dyspnea, using a
technologically-enhanced RESP-FIT intervention. Our overarching hypothesis is that a training
regimen consisting of RMST along with technology-enhanced symptom-tracking will decrease
dyspnea, dyspnea-related activity avoidance, and fatigue. Additionally, this application
proposes to further develop Smartphone Airway Monitoring System (SAMS) which currently
integrates EMA probe questions covering COPD symptoms and preventive care use with the new
functions, use in an adult population with COPD, video captured training technique and
logging of RMST training sessions. Up to thirty adults with COPD (age over 40) will complete
the study and use the SAMS app for 6 weeks in the natural environment. We will evaluate the
acceptability, feasibility, adherence, and performance of RESP-FIT + SAMS through
quantitative methods to further optimize the app and related study procedures for the next
phase of testing (i.e., large scale efficacy RCT).
Inclusion Criteria:
- 40 years of age or older; and
- Able to read and write English; and
- Diagnosed with mild to moderate COPD (PFT values: FEV1/FVC <0.7 and FEV1% predicted <
50% - within the past 6 months); and
- Dyspnea score of greater than "2" on the Modified Medical Research Council (MMRC)
questionnaire.
Exclusion Criteria:
- • Pregnant female or less than 1 year post-partum; or
- Diagnosed cognitive deficit or observed lack of understanding during the informed
consent process; or
- Mobility impairment; or
- Lack of 3g WiFi access in place of residence; or
- Unwillingness to wear physical activity tracker daily, follow protocol, and/ or
attend study visits.
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Phone: 843-792-7309
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