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.

Study Overview

• Status: Not yet recruiting
• Conditions: COPD; Dyspnea; COPD (Chronic Obstructive Pulmonary Disease); Respiratory Muscle Strength Training
• Intervention / Treatment: Behavioral: RESPFIT Intervention

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 Type: Interventional
• Enrollment (Estimated): 288
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mary Chris S. Pittman, BA; Phone Number: 8437923512; Email: pittmama@musc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RESPFIT Intervention Arm; 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; 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.
No Intervention: No Intervention Enhanced Usual Care Group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximal Inspiratory Pressure (PImax)	Maximal inspiratory pressure measured using the POWERbreathe Smart Adaptor digital pressure transducer connected to a mouthpiece.	Baseline to 3 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 3 Months
Change in Breathlessness Beliefs Questionnaire (BBQ) Score	Dyspnea-related kinesiophobia assessed using the Breathlessness Beliefs Questionnaire (BBQ), a validated 17-item instrument that measures dysfunctional beliefs about breathlessness related to physical activity.	Baseline to 3 Months
Change in Modified Medical Research Council (mMRC) Dyspnea Scale Score	Dyspnea severity measured using the Modified Medical Research Council (mMRC) Dyspnea Scale.	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.	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).	Baseline to 3 Months
Change in Average Daily Step Count	Physical activity measured using a Garmin wearable activity monitor.	Baseline to 3 Months
Change in Daily Sedentary Time	Sedentary behavior measured using a Garmin wearable activity monitor.	Baseline to 3 Months
Change in Moderate-to-Vigorous Physical Activity Time	Moderate-to-vigorous physical activity measured using a Garmin wearable activity monitor.	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.	Baseline to 3 Months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 months

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Institute of Nursing Research (NINR); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Sarah Miller, PhD, RN, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): April 15, 2030
• Study Completion (Estimated): May 15, 2031

Study Registration Dates

• First Submitted: August 21, 2026
• First Submitted That Met QC Criteria: September 4, 2026
• First Posted (Actual): September 10, 2026

Study Record Updates

• Last Update Posted (Actual): September 10, 2026
• Last Update Submitted That Met QC Criteria: September 4, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: COPD; Chronic Obstructive Pulmonary Disease; Dyspnea; Respiratory muscle training
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Diseases, Obstructive; Signs and Symptoms, Respiratory; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: Pro00149990; 1R01NR021347-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study Protocol
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes