COPD (Chronic Obstructive Pulmonary Disease)
Conditions
Keywords
COPD, Respiratory muscle training, Dyspnea, Chronic Obstructive Pulmonary Disease
Brief summary
Individuals with chronic obstructive pulmonary disease (COPD) often experience dyspnea, low physical activity, and reduced quality of life. RESP-FIT is a randomized controlled trial evaluating a remotely delivered respiratory muscle strength training intervention combined with mobile health tools to improve dyspnea, respiratory muscle strength, and physical activity in adults with COPD.
Detailed description
This randomized, parallel-group clinical trial will enroll adults with COPD and assign them 1:1 to either the RESP-FIT intervention or enhanced usual care. The RESP-FIT intervention includes respiratory muscle strength training using a commercially available inspiratory muscle trainer, remote spirometry, physical activity monitoring, ecological momentary assessment of symptoms, and a mobile application for monitoring and feedback. Primary and secondary outcomes include dyspnea, dyspnea-related kinesiophobia, respiratory muscle strength, physical activity, lung function, and quality of life, assessed over a 6-month follow-up period. All study activities are conducted remotely.
Interventions
BEHAVIORALRESPFIT Intervention
The RESP-FIT intervention group will receive the full intervention, including respiratory muscle strength training (RMST), EMA symptom management through the RESP-FIT app, ecological momentary assessment (EMA) symptom tracking through the mobile application, and physical activity monitoring using the Garmin activity monitor. Participants will receive instructions from study personnel on RMST device use and will follow a simple 5x5x5 training protocol (5 breaths, 5 times a day, 5 times a week) over the intervention period of 6 months. Participants will also be asked to record training sessions and symptoms using the mobile application. Participants will receive on-going support and monitoring from study personnel for the first 3 months and can use app and devices at will for the next 3 months until the 6 month assessment period when the study procedures end.
Sponsors
Medical University of South Carolina
National Institute of Nursing Research (NINR)
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥40 years * Clinical diagnosis of COPD * Ability to provide informed consent * Willingness to use mobile health devices and apps * Access to Wi-Fi and mailing address in the U.S.
Exclusion criteria
* Cognitive impairment preventing participation * Active substance abuse * Other significant respiratory disease * Concurrent enrollment in conflicting COPD or behavioral intervention trials * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Maximal Inspiratory Pressure (PImax) | Baseline to 3 Months | Maximal inspiratory pressure measured using the POWERbreathe Smart Adaptor digital pressure transducer connected to a mouthpiece. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Modified Borg Dyspnea Scale Score | Baseline to 3 Months | Dyspnea severity assessed using the Modified Borg Scale delivered through ecological momentary assessment (EMA) within the study mobile application. Scores range from 0-10, with 0 indicating no breathlessness and 10 indicating maximal breathlessness. Higher scores indicate greater dyspnea severity. |
| Change in Breathlessness Beliefs Questionnaire (BBQ) Score | Baseline to 3 Months | Dyspnea-related kinesiophobia assessed using the Breathlessness Beliefs Questionnaire (BBQ), a validated 11-item instrument that measures dysfunctional beliefs about breathlessness related to physical activity. Items are rated on a 5-point scale, yielding a total score ranging from 11-55, with higher scores indicating stronger beliefs about breathlessness and greater dyspnea-related fear and activity avoidance. |
| Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score | Baseline to 3 Months | Breathlessness measured using the Modified Medical Research Council (mMRC) Dyspnea Scale, a 5-grade scale that assesses the degree to which breathlessness limits daily physical activities. Scores range from 0-4, with higher scores indicating breathlessness that prevents leaving the house or occurring during dressing/undressing. Higher scores indicate worse dyspnea-related functional limitation. |
| Change in PROMIS Dyspnea-Related Activity Avoidance Score | Baseline to 3 Months | Activity avoidance due to breathing discomfort assessed using the PROMIS Dyspnea-Related Activity Avoidance instrument. This is a 5 point Likert scale with 3 items measuring avoidance of activities due to shortness of breath or phsyical limitations over the past 7 days, scored from 0 (not at all) to 4 (very much), yielding total raw score range of 0-12. Higher scores indicate greater dyspnea-related task avoidance. |
| Change in St. George's Respiratory Questionnaire (SGRQ) Total Score | Baseline to 3 Months | Respiratory-related quality of life assessed using the St. George's Respiratory Questionnaire (SGRQ) for COPD. This is contains 40 items assessing three domains (symptoms, activity, and impact) and a total score ranging from 0-100, with 0 indicating no impairment and 100 indicating maximum impairment. Higher scores indicate greater impairment in respiratory related quality of life. |
| Change in Average Daily Step Count | Baseline to 3 Months | Physical activity measured using a Garmin wearable activity monitor, with daily steps captured numerically in number of steps. |
| Change in CAPTURE Score | Baseline to 3 Months | COPD symptoms and exacerbation risk assessed using the COPD Assessment in Primary Care to Identify Undiagnosed Respiratory Disease and Exacerbation Risk (CAPTURE) questionnaire. This is a 5 item instrument assessing respiratory symptoms, risk exposures, recent acute respiratory illnesses with a total score range of 0-6, with higher scores indicating greater likelihood of clinically significant COPD and exacerbation risk. |
Contacts
CONTACTMary Chris S. Pittman, BA
PRINCIPAL_INVESTIGATORSarah Miller, PhD, RN
Medical University of South Carolina
Outcome results
None listed