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

NCT07811219 | Not Yet Recruiting DMC

• 2 other identifiers: Pro001499901R01NR021347-01A1
• Study Type: interventional
• Target: 288
• Locations: 0 countries
• Sites: N/A

Brief 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, respiratory muscle strength, and physical activity in adults with COPD.

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Keywords

COPD; Respiratory muscle training; Dyspnea; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in Modified Borg Dyspnea Scale Score

  Baseline to 3 Months

• Change in Breathlessness Beliefs Questionnaire (BBQ) Score

  Baseline to 3 Months

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

  Baseline to 3 Months

• Change in PROMIS Dyspnea-Related Activity Avoidance Score

  Baseline to 3 Months

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

  Baseline to 3 Months

Other Outcomes (1)

• Qualitative Measures

  3 months

Study Arms (2)

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.

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.

Interventions

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.

RESPFIT Intervention Arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Cognitive impairment preventing participation
• Active substance abuse
• Other significant respiratory disease
• Concurrent enrollment in conflicting COPD or behavioral intervention trials
• Non-English speaking

Sponsors & Collaborators

• Medical University of South Carolina: lead
• National Institute of Nursing Research (NINR): collaborator
• National Institutes of Health (NIH): collaborator

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Sarah Miller, PhD, RN

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Chris S. Pittman, BA

CONTACT

8437923512; pittmama@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: September 10, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): April 15, 2030
• Study Completion (Estimated): May 15, 2031
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL