Ignite Creation Date:
2024-05-06 @ 7:33 PM
Last Modification Date:
2024-10-26 @ 3:09 PM
Study NCT ID:
NCT06053164
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2023-08-03
Brief Title:
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Sponsor:
University of Alberta
Organization:
University of Alberta
Study Overview
Official Title:
Ambulatory Oxygen Therapy for Individuals With Mild-to-moderate Interstitial Lung Disease
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators plan to conduct a study to find out if giving portable oxygen therapy during physical activity to patients with interstitial lung disease will improve quality of life exercise tolerance shortness of breath and blood vessel function Oxygen will be provided for a period of 8 weeks Additionally the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy through check-in phone calls with a respiratory therapist and by providing additional educational material
Detailed Description:
Brief Summary
The investigators plan to conduct a study to find out if giving portable oxygen therapy during physical activity to patients with interstitial lung disease will improve quality of life exercise tolerance shortness of breath and blood vessel function Oxygen will be provided for a period of 8 weeks Additionally the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy through check-in phone calls with a respiratory therapist and by providing additional educational material
Detailed Description
BACKGROUND
Interstitial lung disease ILD is comprised of a group of pulmonary diseases that are characterized by inflammation andor lung parenchymal fibrosis Individuals with ILD may be normoxic at rest however underlying impairments in gas exchange can contribute to a reduction in oxygen saturation SpO2 during exertion Hypoxemia can cause inflammation and cardiovascular dysfunction which could lead to cardiac events A recent study found that 78 of ILD patients had cardiovascular comorbidity which was predictive of death within this ILD cohort
Oxygen therapy is used in patients with advanced lung disease with resting hypoxemia however there is limited evidence regarding its clinical efficacy Furthermore there is little support to describe the benefit of ambulatory oxygen therapy in individuals with lung disease who are normoxemic at rest but become hypoxemic with exertion Accordingly thresholds for the prescription of oxygen therapy vary between and within health districts and geographical regions and individuals who might benefit from supplemental oxygen typically do not qualify for funding of oxygen therapy under unclear guidelines Furthermore data from studies in patients with chronic obstructive pulmonary disease COPD are often extrapolated for use in guiding oxygen therapy in patients with ILD which is likely inappropriate considering recent research demonstrated that individuals with fibrotic ILD experience greater hypoxemia than those with COPD during the 6-minute walk test 6MWT
Oxygen therapy may be beneficial in reducing inflammation oxidative stress and pulmonary artery pressure all of which are elevated in ILD Furthermore a reduction in dyspnea during exercise with exertional oxygen therapy might increase daily physical activity exercise tolerance and reduce overall sedentary time which would have a positive effect on vascular function These postulated outcomes however are confounded by various practical psychological and social challenges associated with use of an oxygen concentrator as well as challenges with proper titration of oxygen levels accurately targeting appropriate SpO2 in relation to exertional intensity Paradoxically if the flow of oxygen is too high activation of inflammatory and oxidative pathways may inhibit the benefits related to the alleviation of hypoxemia Thus integration of patient-specific disease support tools is essential when initiating oxygen therapy to ensure appropriate oxygenation during exertion
OBJECTIVE To assess the feasibility of oxygen therapy education and support for individuals with fibrotic interstitial lung disease and exertional hypoxemia As a secondary objective the effects of exertional oxygen therapy and support on physical activity vascular function and health-related quality of life in individuals with fibrotic interstitial lung disease will be investigated
PRIMARY AND SECONDARY ENDPOINTS
Health related quality of life as assessed by the EQ-5D-5L and the K-BILD Exercise tolerance assessed by 6MWD while breathing room air Daily physical activity and sedentary time as assessed by a remote monitor Dyspnea as measured by the Dyspnea 12 questionnaire Cough using the visual analog scale VAS and cough score measured by Leicester Cough Questionnaire LCQ Vascular function measured by flow mediated dilation FMD of the brachial artery Pulmonary artery systolic pressure PASP measured by cardiac echocardiography Cardiac systolic and diastolic function assessed by cardiac echocardiography Systemic inflammation
STUDY DESIGN
Single-blind assessment team open-label randomized control
TRIAL TREATMENT
Participants will be randomized into one of three arms
Control
Arm 1 8 Weeks of usual care n20
Treatment
Arm 2 8 Weeks of supplemental oxygenn20
Arm 3 8 Weeks of supplemental oxygen plus educational materials and scheduled support n20
All 2-week baseline prior to intervention and 2-week washout post-intervention to document carry-over effect of intervention
DURATION
Seven sessions will be completed over a 13-week period
TIMELINE
Visit 1 Participant enrollment medical history standard pulmonary function test PFT and 6-minute walk test 6MWT followed by 1-week for collection of baseline physical activity and SpO2 During this visit participants will be provided a wrist-worn activity monitor and a finger-worn pulse oximeter This visit will take approximately 3 hours
Visit 2 Doppler measurements of systemic vascular function flow mediated dilation will be measured at rest while breathing room air A small sample of venous blood will be taken to analyze inflammatory levels and reactive oxygen species Participants will fill out questionnaires relating to health-related quality of life dyspnea and cough Finally participants will perform tests of lung diffusing capacity for carbon monoxide DLCO under three different conditions seated supine and during exercise at 40W on a cycle ergometer
Visit 3 One to three days after Visit 2 participants will return for the second day of pre-intervention baseline testing An echocardiographic exam will be completed to determine pulmonary artery systolic pressure as well as systolic and diastolic function in the left and right ventricles of the heart To enhance the Doppler signal during the cardiac ultrasound agitated saline contrast will be used Two 6-minute walk tests will then be completed separated by half an hour This visit will take approximately 2 hours Following this day participants will be randomized into one of three arms for an 8-week intervention
Eight-week intervention randomized into one of
No oxygen
Exertional oxygen
Exertional oxygen additional support
Visit 4 Repeat Day 2 protocol Visit 5 Repeat Day 3 protocol
Two-week washout period
Visit 6 Repeat Day 2 protocol Visit 7 Repeat Day 3 protocol
The total duration of time spent for each participant will be approximately 12 hours
The investigators plan to conduct a study to find out if giving portable oxygen therapy during physical activity to patients with interstitial lung disease will improve quality of life exercise tolerance shortness of breath and blood vessel function Oxygen will be provided for a period of 8 weeks Additionally the investigators plan to investigate if it is helpful to deliver individualized support when providing oxygen therapy through check-in phone calls with a respiratory therapist and by providing additional educational material
Detailed Description
BACKGROUND
Interstitial lung disease ILD is comprised of a group of pulmonary diseases that are characterized by inflammation andor lung parenchymal fibrosis Individuals with ILD may be normoxic at rest however underlying impairments in gas exchange can contribute to a reduction in oxygen saturation SpO2 during exertion Hypoxemia can cause inflammation and cardiovascular dysfunction which could lead to cardiac events A recent study found that 78 of ILD patients had cardiovascular comorbidity which was predictive of death within this ILD cohort
Oxygen therapy is used in patients with advanced lung disease with resting hypoxemia however there is limited evidence regarding its clinical efficacy Furthermore there is little support to describe the benefit of ambulatory oxygen therapy in individuals with lung disease who are normoxemic at rest but become hypoxemic with exertion Accordingly thresholds for the prescription of oxygen therapy vary between and within health districts and geographical regions and individuals who might benefit from supplemental oxygen typically do not qualify for funding of oxygen therapy under unclear guidelines Furthermore data from studies in patients with chronic obstructive pulmonary disease COPD are often extrapolated for use in guiding oxygen therapy in patients with ILD which is likely inappropriate considering recent research demonstrated that individuals with fibrotic ILD experience greater hypoxemia than those with COPD during the 6-minute walk test 6MWT
Oxygen therapy may be beneficial in reducing inflammation oxidative stress and pulmonary artery pressure all of which are elevated in ILD Furthermore a reduction in dyspnea during exercise with exertional oxygen therapy might increase daily physical activity exercise tolerance and reduce overall sedentary time which would have a positive effect on vascular function These postulated outcomes however are confounded by various practical psychological and social challenges associated with use of an oxygen concentrator as well as challenges with proper titration of oxygen levels accurately targeting appropriate SpO2 in relation to exertional intensity Paradoxically if the flow of oxygen is too high activation of inflammatory and oxidative pathways may inhibit the benefits related to the alleviation of hypoxemia Thus integration of patient-specific disease support tools is essential when initiating oxygen therapy to ensure appropriate oxygenation during exertion
OBJECTIVE To assess the feasibility of oxygen therapy education and support for individuals with fibrotic interstitial lung disease and exertional hypoxemia As a secondary objective the effects of exertional oxygen therapy and support on physical activity vascular function and health-related quality of life in individuals with fibrotic interstitial lung disease will be investigated
PRIMARY AND SECONDARY ENDPOINTS
Health related quality of life as assessed by the EQ-5D-5L and the K-BILD Exercise tolerance assessed by 6MWD while breathing room air Daily physical activity and sedentary time as assessed by a remote monitor Dyspnea as measured by the Dyspnea 12 questionnaire Cough using the visual analog scale VAS and cough score measured by Leicester Cough Questionnaire LCQ Vascular function measured by flow mediated dilation FMD of the brachial artery Pulmonary artery systolic pressure PASP measured by cardiac echocardiography Cardiac systolic and diastolic function assessed by cardiac echocardiography Systemic inflammation
STUDY DESIGN
Single-blind assessment team open-label randomized control
TRIAL TREATMENT
Participants will be randomized into one of three arms
Control
Arm 1 8 Weeks of usual care n20
Treatment
Arm 2 8 Weeks of supplemental oxygenn20
Arm 3 8 Weeks of supplemental oxygen plus educational materials and scheduled support n20
All 2-week baseline prior to intervention and 2-week washout post-intervention to document carry-over effect of intervention
DURATION
Seven sessions will be completed over a 13-week period
TIMELINE
Visit 1 Participant enrollment medical history standard pulmonary function test PFT and 6-minute walk test 6MWT followed by 1-week for collection of baseline physical activity and SpO2 During this visit participants will be provided a wrist-worn activity monitor and a finger-worn pulse oximeter This visit will take approximately 3 hours
Visit 2 Doppler measurements of systemic vascular function flow mediated dilation will be measured at rest while breathing room air A small sample of venous blood will be taken to analyze inflammatory levels and reactive oxygen species Participants will fill out questionnaires relating to health-related quality of life dyspnea and cough Finally participants will perform tests of lung diffusing capacity for carbon monoxide DLCO under three different conditions seated supine and during exercise at 40W on a cycle ergometer
Visit 3 One to three days after Visit 2 participants will return for the second day of pre-intervention baseline testing An echocardiographic exam will be completed to determine pulmonary artery systolic pressure as well as systolic and diastolic function in the left and right ventricles of the heart To enhance the Doppler signal during the cardiac ultrasound agitated saline contrast will be used Two 6-minute walk tests will then be completed separated by half an hour This visit will take approximately 2 hours Following this day participants will be randomized into one of three arms for an 8-week intervention
Eight-week intervention randomized into one of
No oxygen
Exertional oxygen
Exertional oxygen additional support
Visit 4 Repeat Day 2 protocol Visit 5 Repeat Day 3 protocol
Two-week washout period
Visit 6 Repeat Day 2 protocol Visit 7 Repeat Day 3 protocol
The total duration of time spent for each participant will be approximately 12 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None