Breathing Training and Exercise Capacity in Non-CFB

Not Applicable

Recruiting

• Conditions: Non-cystic Fibrosis Bronchiectasis
• Interventions: Device: LungTrainers; Behavioral: LungTrainers Pulmonary Rehabilitation regime

• Registration Number: NCT05860803
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to investigate whether a home-based and health coach supported specific breathing and respiratory muscle training program improves the ability to exercise, the function of the lungs and breathing muscles, and general clinical status in people with non-cystic fibrosis bronchiectasis (non-CFB).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-05-08
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-16
• Study Start: 2024-01-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-27
• Last Update Posted: 2024-03-28
• Primary Completion: 2025-12-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Mayo Clinic patient with confirmed diagnosis of Non-Cystic Fibrosis Bronchiectasis (non-CFB): Non-CFB as confirmed by clinical history, including cough, shortness of breath, exertional dyspnea, pulmonary function tests, and high-resolution computed tomography. Patients will be considered clinically stable if there is no evidence of an exacerbation or change(s) in medical therapy in the previous three weeks.
• Able and willing to provide informed consent to participate in the study.

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Exclusion Criteria

• Presence of significant coexisting disease, neurological conditions, and/or orthopedic complications that affect ability to undertake exercise.
• Presence of advanced heart failure.
• Current use of antibiotics.
• Acute exacerbation(s) within 3-weeks prior to study commencement.
• Participation within a pulmonary rehabilitation program within 6-months prior to study commencement.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-based specific breathing and respiratory muscle training group	LungTrainers	In addition standard of care pulmonary rehabilitation, subjects will participate in an 8-week home-based specific breathing and respiratory muscle training via the LungTrainers Pulmonary Rehabilitation regime (LT-PR).
Home-based specific breathing and respiratory muscle training group	LungTrainers Pulmonary Rehabilitation regime	In addition standard of care pulmonary rehabilitation, subjects will participate in an 8-week home-based specific breathing and respiratory muscle training via the LungTrainers Pulmonary Rehabilitation regime (LT-PR).

Primary Outcome Measures

Name	Time	Method
Change in six-minute walk test distance	Baseline, 8 weeks	Measures the distance walked in meters for 6 minutes.
Change in peak oxygen uptake during maximal incremental exercise test	Baseline, 8 weeks	Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).

Secondary Outcome Measures

Name	Time	Method
Change in exercise time during maximal incremental exercise test	Baseline, 8 weeks	Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Change in diaphragm thickness	Baseline, 8 weeks	Ultrasound-derived diaphragm thickness, reported centimeters (cm)
Change in forced expiratory volume in 1 second	Baseline, 8 weeks	Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath.
Change in diaphragm excursion	Baseline, 8 weeks	Ultrasound-derived diaphragm excursion defined as the amplitude of excursion from baseline to the point of maximum height during the sniff, reported in centimeters (cm).
Change in maximal voluntary ventilation	Baseline, 8 weeks	Measured by spirometry to determine the largest amount of air inhaled and exhaled during maximal voluntary effort.
Change in maximal inspiratory pressure	Baseline, 8 weeks	Assessed using a calibrated pressure meter to evaluate inspiratory muscle strength. After exhaling slowly and maximally (i.e., to residual volume), the subject will be urged strongly to 'suck-in as maximally as possible' (Mueller maneuver) for approximately 3 to 5 seconds. Measured by 3-5 repetitions and defined as the highest value (in cmH2O) of three measurements that vary by ≤5%.
Change in maximal expiratory mouth pressure	Baseline, 8 weeks	Assessed using a calibrated pressure meter to evaluate expiratory muscle strength. After inhaling slowly and maximally (i.e., to total lung capacity), the patient will be strongly urged to 'blow-out as maximally as possible' (Valsalva maneuver) for approximately 3 to 5 seconds. Measured by 3-5 repetitions and defined as the highest value (in cmH2O) of three measurements that vary by ≤5%.
Change in diaphragm thickening fraction	Baseline, 8 weeks	Ultrasound-derived diaphragm thickening fraction defined as ratio of at total lung capacity thickness at functional residual capacity to thickness at functional residual capacity, reported in millimeters (mm).
Change in Dartmouth COOP Functional Assessment Charts	Baseline, 8 weeks	The Dartmouth COOP chart consists of nine questions measuring seven domains of health status: physical fitness, feelings, daily activities, social activities, change in health status, current overall health perceptions, bodily pain, social support, and quality of life. Each question has five response options.
Peak exercise work rate during maximal incremental exercise test	Baseline, 8 weeks	Highest work rate achieved during cardiopulmonary exercise test (treadmill or cycle)
Change in forced vital capacity	Baseline, 8 weeks	Measured by spirometry to determine the maximal amount of air that can be forcibly exhaled from the lungs after a full inhale, reported as liters (L).
Change in St. George's Respiratory Questionnaire (SGRQ)	Baseline, 8 weeks	SGRQ measures impact on overall health, daily life, and perceived well-being in patients with lung disease, specifically obstructive airways disease. The questionnaire consists of two parts with three components; Part 1: symptoms component (frequency \& severity) with a 1, 3 or 12-month recall (best performance with 3- and 12-month recall); Part 2: activities that cause or are limited by breathlessness; Impact components (social functioning, psychological disturbances resulting from airways disease) refer to current state as the recall. Scores range from 0 to 100, with higher scores indicating more limitations.
Change in Modified Medical Research Council Dyspnea Scale (mMRC)	Baseline, 8 weeks	mMRC scale is a self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4 which 0=no breathlessness except on strenuous exercise; 1=shortness of breath when hurrying on the level or walking up a slight hill; 2=walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3=stops for breath after walking approximately 100 m or after few minutes on the level; and 4=too breathless to leave the house, or breathless when dressing or undressing.

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States