Back to resultsBreathing Training and Exercise Capacity in Non-CFB
Primary Purpose
Non-cystic Fibrosis Bronchiectasis
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
LungTrainers
LungTrainers Pulmonary Rehabilitation regime
Sponsored by
About this trial
This is an interventional treatment trial for Non-cystic Fibrosis Bronchiectasis
Eligibility Criteria
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. 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.
Sites / Locations
- Mayo Clinic Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group of standard physician directed care
Home-based specific breathing and respiratory muscle training group
Arm Description
Subjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care').
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).
Outcomes
Primary Outcome Measures
Change in six-minute walk test distance
Measures the distance walked in meters for 6 minutes.
Change in peak oxygen uptake during maximal incremental exercise test
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Secondary Outcome Measures
Change in exercise time during maximal incremental exercise test
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Peak exercise work rate during maximal incremental exercise test
Highest work rate achieved during cardiopulmonary exercise test (treadmill or cycle)
Change in forced vital capacity
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 forced expiratory volume in 1 second
Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath.
Change in maximal voluntary ventilation
Measured by spirometry to determine the largest amount of air inhaled and exhaled during maximal voluntary effort.
Change in maximal inspiratory pressure
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
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 thickness
Ultrasound-derived diaphragm thickness, reported centimeters (cm)
Change in diaphragm thickening fraction
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 diaphragm excursion
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 Modified Medical Research Council Dyspnea Scale (mMRC)
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.
Change in St. George's Respiratory Questionnaire (SGRQ)
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 Dartmouth COOP Functional Assessment Charts
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05860803
Brief Title
Breathing Training and Exercise Capacity in Non-CFB
Official Title
Home-based, Digitally Delivered Breathing Training in People With Non-cystic Fibrosis Bronchiectasis: A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-cystic Fibrosis Bronchiectasis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The study staff who administer clinical testing before and after LT-PR will be blinded to the patient's group allocation.
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group of standard physician directed care
Arm Type
No Intervention
Arm Description
Subjects will receive pulmonary rehabilitation via standard physician directed care (i.e., 'normal care').
Arm Title
Home-based specific breathing and respiratory muscle training group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
LungTrainers
Intervention Description
A training device that provides a variable resistance against which users breathe out. Users breathe through a plastic mouthpiece that is connected to an acrylic cylinder via rubber tubing. The mouthpiece has several small holes of various diameters and up to three stainless steel weights (half-weight increments) can be inserted into the acrylic tube. With each breath-out, the user exhales against the resistance provided by the weight inserts, and each inspiration (i.e., breath-in) is unresisted. During each resisted exhalation, the weight inserts are 'lifted' within the acrylic tube depending on the level of expiratory pressure generated by the participant.
Intervention Type
Behavioral
Intervention Name(s)
LungTrainers Pulmonary Rehabilitation regime
Other Intervention Name(s)
LT-PR
Intervention Description
Series of different exercises using the LungTrainers device 3-5 days per week for approximately 10 weeks. Exercises complete in one long session (20-30 minutes) or be broken down into multiple shorter sessions (e.g., 3 x 10 minutes). A health coach will be assigned to guide participants through the LT-PR program.
Primary Outcome Measure Information:
Title
Change in six-minute walk test distance
Description
Measures the distance walked in meters for 6 minutes.
Time Frame
Baseline, 8 weeks
Title
Change in peak oxygen uptake during maximal incremental exercise test
Description
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Change in exercise time during maximal incremental exercise test
Description
Maximum volume or amount of oxygen consumption during cardiopulmonary exercise test (treadmill or cycle).
Time Frame
Baseline, 8 weeks
Title
Peak exercise work rate during maximal incremental exercise test
Description
Highest work rate achieved during cardiopulmonary exercise test (treadmill or cycle)
Time Frame
Baseline, 8 weeks
Title
Change in forced vital capacity
Description
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).
Time Frame
Baseline, 8 weeks
Title
Change in forced expiratory volume in 1 second
Description
Measured by spirometry to determine the volume of air that can be exhaled in 1 second with a forced breath.
Time Frame
Baseline, 8 weeks
Title
Change in maximal voluntary ventilation
Description
Measured by spirometry to determine the largest amount of air inhaled and exhaled during maximal voluntary effort.
Time Frame
Baseline, 8 weeks
Title
Change in maximal inspiratory pressure
Description
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%.
Time Frame
Baseline, 8 weeks
Title
Change in maximal expiratory mouth pressure
Description
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%.
Time Frame
Baseline, 8 weeks
Title
Change in diaphragm thickness
Description
Ultrasound-derived diaphragm thickness, reported centimeters (cm)
Time Frame
Baseline, 8 weeks
Title
Change in diaphragm thickening fraction
Description
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).
Time Frame
Baseline, 8 weeks
Title
Change in diaphragm excursion
Description
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).
Time Frame
Baseline, 8 weeks
Title
Change in Modified Medical Research Council Dyspnea Scale (mMRC)
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change in St. George's Respiratory Questionnaire (SGRQ)
Description
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.
Time Frame
Baseline, 8 weeks
Title
Change in Dartmouth COOP Functional Assessment Charts
Description
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.
Time Frame
Baseline, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan Taylor, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Breathing Training and Exercise Capacity in Non-CFB
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