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NCT Number: NCT07811219

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

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Dyspnea Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in Modified Borg Dyspnea Scale Score

    Time frame: 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.

  2. Change in Breathlessness Beliefs Questionnaire (BBQ) Score

    Time frame: 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.

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

    Time frame: 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.

  4. Change in PROMIS Dyspnea-Related Activity Avoidance Score

    Time frame: 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.

  5. Change in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Time frame: 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.

  6. Change in Average Daily Step Count

    Time frame: Baseline to 3 Months

    Physical activity measured using a Garmin wearable activity monitor, with daily steps captured numerically in number of steps.

  7. Change in CAPTURE Score

    Time frame: 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.

Other outcomes

  1. Qualitative Measures

    Time frame: 3 months

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mary Chris S. Pittman, BA

CONTACT

[email protected]

8437923512

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Sep 10, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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