RESP-FIT: A Respiratory Muscle Strength Training Intervention for COPD

ConditionCOPD (Chronic Obstructive Pulmonary Disease)

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age40+

SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥40 years

Clinical diagnosis of COPD

Ability to provide informed consent

Willingness to use mobile health devices and apps

Disqualifiers

Cognitive impairment preventing participation

Active substance abuse

Other significant respiratory disease

Concurrent enrollment in conflicting COPD or behavioral intervention trials

Trial design

Design model

Parallel

Treatments tested in this trial

RESPFIT Intervention
Behavioral
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.

Treatment groups

288 Participants

are divided into 2 treatment groups

Group A: RESPFIT Intervention ArmExperimental treatment 1 intervention

Group B: No Intervention Enhanced Usual Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

Change in Maximal Inspiratory Pressure (PImax)

Maximal inspiratory pressure measured using the POWERbreathe Smart Adaptor digital pressure transducer connected to a mouthpiece.

Time frame

Baseline to 3 Months

Secondary outcomes

Change in Modified Borg Dyspnea Scale Score

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.

Time frame

Baseline to 3 Months

Change in Breathlessness Beliefs Questionnaire (BBQ) Score

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.

Time frame

Baseline to 3 Months

Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score

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.

Time frame

Baseline to 3 Months

Change in PROMIS Dyspnea-Related Activity Avoidance Score

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.

Time frame

Baseline to 3 Months

Other outcomes

Qualitative Measures

Semi-structured interviews assessing intervention accessibility, usability, symptom monitoring, dyspnea-related activity avoidance, disease self-management, and overall participant experiences with RESP-FIT

Time frame

3 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

National Institute of Nursing Research (NINR)

Collaborator

National Institutes of Health (NIH)

Collaborator

Source ClinicalTrials.gov

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