An interventional study of RESPFIT Intervention in COPD (Chronic Obstructive Pulmonary Disease), sponsored by Medical University of South Carolina. Not yet recruiting. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Supportive care
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 288 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The RESP-FIT intervention group will receive the full intervention, including respiratory muscle strength training (RMST), ecological momentary assessment (EMA) symptom tracking through the mobile application, and physical activity monitoring using an 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. Participants will be asked to record training sessions and symptoms using the mobile application. The intervention period will last 6 months, with the primary endpoint occurring at 3 months following baseline. Outcome assessments will occur at baseline and at 1, 2, 3, and 6 months.
Behavioral: RESPFIT Intervention
Participants randomized to the control group will receive enhanced usual care (eUC). This consists of their standard COPD management provided by their healthcare providers along with the mobile app for remote spirometry and symptom tracking and physical activity monitoring using the Garmin wearable activity tracker. Control group participants will also receive publicly available COPD educational materials (via COPD Foundation resources). Providing an activity monitor to both groups allows the research team to account for potential effects of activity monitoring on physical activity behavior.
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.
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
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
Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
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.
Time frame: Baseline to 3 Months
Change in Average Daily Step Count
Physical activity measured using a Garmin wearable activity monitor, with daily steps captured numerically in number of steps.
Time frame: Baseline to 3 Months
Change in CAPTURE Score
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.
Time frame: Baseline to 3 Months
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
No study locations are listed for this record.
Plan to share: Yes — Study Protocol
Supporting information: Study protocol
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Pulmonary Disease, Chronic Obstructive →
Medical University of South Carolina →