COPD (Chronic Obstructive Pulmonary Disease)NCT07811219
RESP-FIT: A Respiratory Muscle Strength Training Intervention for COPD
A study testing RESPFIT Intervention in people with COPD (Chronic Obstructive Pulmonary Disease), run by Medical University of South Carolina.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- RESPFIT Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 May 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive impairment preventing participation
- Active substance abuse
- Other significant respiratory disease
- Concurrent enrollment in conflicting COPD or behavioral intervention trials
- Non-English speaking
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Being tested
- RESPFIT Intervention
- Keywords
- COPD, Respiratory muscle training, Dyspnea, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESPFIT InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| RESPFIT Intervention Arm | Experimental | 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. Receives: Behavioral: RESPFIT Intervention |
| No Intervention Enhanced Usual Care Group | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Inspiratory Pressure (PImax)
Maximal inspiratory pressure measured using the POWERbreathe Smart Adaptor digital pressure transducer connected to a mouthpiece.
Measured: Baseline to 3 Months
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Apr 2030 (estimated)
- Study completion15 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Sarah Miller, PhD, RN, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811219
- Sponsor's protocol ID
- Pro00149990
- Other IDs
- 1R01NR021347-01A1
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESP-FIT: A Respiratory Muscle Strength Training Intervention for COPD
- ClinicalTrials.gov ID
- NCT07811219
- Acronym / sponsor ID
- Pro00149990
- Keywords
- COPD, Respiratory muscle training, Dyspnea, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Apr 2030 (estimated)
- Study completion
- 15 May 2031 (estimated)
- First posted
- 10 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESPFIT Intervention Arm | Experimental | Behavioral: RESPFIT InterventionThe 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. |
| No Intervention Enhanced Usual Care Group | No 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Cognitive impairment preventing participation
- Active substance abuse
- Other significant respiratory disease
- Concurrent enrollment in conflicting COPD or behavioral intervention trials
- Non-English speaking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RESPFIT InterventionThe 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. | Behavioural | RESPFIT Intervention Arm |
Primary outcome
Change in Maximal Inspiratory Pressure (PImax)
Time frame: Baseline to 3 Months
Maximal inspiratory pressure measured using the POWERbreathe Smart Adaptor digital pressure transducer connected to a mouthpiece.
7 secondary outcomes
Change in Modified Borg Dyspnea Scale Score
Time frame: Baseline to 3 Months
Change in Breathlessness Beliefs Questionnaire (BBQ) Score
Time frame: Baseline to 3 Months
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score
Time frame: Baseline to 3 Months
Change in PROMIS Dyspnea-Related Activity Avoidance Score
Time frame: Baseline to 3 Months
Change in St. George's Respiratory Questionnaire (SGRQ) Total Score
Time frame: Baseline to 3 Months
Change in Average Daily Step Count
Time frame: Baseline to 3 Months
Change in CAPTURE Score
Time frame: Baseline to 3 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Study Protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Miller, PhD, RN principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing RESPFIT Intervention in people with COPD (Chronic Obstructive Pulmonary Disease), run by Medical University of South Carolina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary Chris S. Pittman, BA (8437923512, pittmama@musc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximal Inspiratory Pressure (PImax) (time frame: Baseline to 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2026.