RESP-FIT: Technology-Enhanced Self-Management in COPD

NCT ID: NCT03652662

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-18
• Study Completion Date: 2020-01-13

Brief Summary

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.

Detailed Description

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).

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

RESP-FIT Intervention

Intervention:

IMST/EMST Training (5 breaths, 5 times a day, 5 times a week) Fitbit activity monitoring Daily symptom and training log entered into mobile application (SAMS)

Group Type: EXPERIMENTAL

RESP-FIT

Intervention Type: DEVICE

Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)

RESP-FIT Comparator

Active Comparator:

Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)

Group Type: ACTIVE_COMPARATOR

RESP-FIT Comparator

Intervention Type: BEHAVIORAL

Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)

Interventions

RESP-FIT

Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)

Intervention Type: DEVICE

RESP-FIT Comparator

Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)

Intervention Type: BEHAVIORAL

Other Intervention Names

Combined IMST/EMST; Activity and Symptom Monitoring Only

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Florida

OTHER

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Miller, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Pro00071706

Identifier Type: -

Identifier Source: org_study_id