Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?
Primary Purpose
Intersticial Lung Disease
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Intersticial Lung Disease
Eligibility Criteria
Inclusion Criteria:
- Age > 30 years old
- Diagnostic of ILD according to the national and international guidelines 23
- Being clinically stable the previous 4 weeks
- Acceptance to participate in the trial
Exclusion Criteria:
- Have been enrolled in a PR program in the last previous 6 months
- Respiratory Diseases other than ILD or severe comorbidities
- Osteoarticular diseases which don't allow training
- End-stage ILD, treatment with opiates or survival < 6 months
- Cognitive alterations that preclude colaboration
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Conventional oxygen (EPIDOC)
Nasal High-Flow oxygen therapy (EPIDOAF)
Arm Description
Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems.
Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems.
Outcomes
Primary Outcome Measures
Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
To compare the level of oxygenation (in SatO2 %) achieved by conventional oxygen therapy and nasal high flow oxygen therapy during muscular training program in patients with ILD measured by pulseoxymetry.
Secondary Outcome Measures
Dyspnoea (benefits in borg scale) DURING effort.
To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale.
Effort capacity (Benefits in terms of meters walked in the 6mwt).
To compare the benefits achieved by both systems in terms of Effort tolerance after PR program, evaluated with the 6 minut waking test (6WT), in meters.
Basal dyspnoea (mesured by mMRC scale).
To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale.
Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).
To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire.
Quality of life (SF36 questionnaire).
To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire).
Quality of life (KBILD questionnaire).
To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire).
Full Information
NCT ID
NCT03287713
First Posted
August 9, 2017
Last Updated
September 15, 2017
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
1. Study Identification
Unique Protocol Identification Number
NCT03287713
Brief Title
Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?
Official Title
Can Nasal High-Flow Oxygen Therapy Improve Oxygenation During Exercise, Optimizing Benefits of Pulmonary Rehabilitation in Patients With Interstitial Lung Disease (ILD) With Exercise Desaturation?
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives: 1.- To compare the level of oxygenation achieved during muscular training with conventional oxygen systems (nasal cannulas) versus nasal High-flow oxygen therapy. 2.-To compare benefits achieved with both systems, in terms of: level of exercise during training; effort tolerance in the 6 minutes walking test (6MWT); improvement of dyspnoea and Health-related quality of life (HRQoL). And analyse the effects of nasal High-flow oxygen therapy on the acute exercise in a subgroup of patients.
Method: Multicentric randomized clinical trial. Patients with ILD in fibrotic phase who present oxygen desaturation during 6MWT (SpO2 mean ≤ 85%) will be included consecutively. Will be randomized in two groups: ILD patients with conventional oxygen (EPIDOC) and ILD patients with nasal High-Flow oxygen therapy (EPIDOAF). Both groups will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated respectively to flow and FiO2 needed to maintain SpO2 ≥ 90% during training with both systems. Evaluation measures: SpO2 during training in both groups; dyspnoea (mMRC scale and CRQ dyspnoea); exercise capacity (6MWT) and HRQoL (self- administered KBILD questionnaire and SF36). In a subgroup of patients will be compared time of endurance exercise to evaluate the effects of nasal high-flow oxygen therapy in the acute exercise.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intersticial Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional oxygen (EPIDOC)
Arm Type
Active Comparator
Arm Description
Patients randomized in conventional oxygen (EPIDOC) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to flow needed to maintain SpO2 ≥ 90% during training with both systems.
Arm Title
Nasal High-Flow oxygen therapy (EPIDOAF)
Arm Type
Active Comparator
Arm Description
Patients will be randomized in nasal High-Flow oxygen therapy (EPIDOAF) group will perform a Pulmonary Rehabilitation Program. Oxygen will be titrated to FiO2 needed to maintain SpO2 ≥ 90% during training with both systems.
Intervention Type
Drug
Intervention Name(s)
oxygen therapy
Intervention Description
conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.
Primary Outcome Measure Information:
Title
Level of Sat O2 achived (in %) by conventional O2 vs nasal high flow oxygen during Pulmonary Rehabilitation
Description
To compare the level of oxygenation (in SatO2 %) achieved by conventional oxygen therapy and nasal high flow oxygen therapy during muscular training program in patients with ILD measured by pulseoxymetry.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Dyspnoea (benefits in borg scale) DURING effort.
Description
To compare the benefits in dyspnoea achieved by both systems in terms of Effort level during the training period measured by Borg Scale.
Time Frame
8 weeks
Title
Effort capacity (Benefits in terms of meters walked in the 6mwt).
Description
To compare the benefits achieved by both systems in terms of Effort tolerance after PR program, evaluated with the 6 minut waking test (6WT), in meters.
Time Frame
8 weeks
Title
Basal dyspnoea (mesured by mMRC scale).
Description
To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by mMRC scale.
Time Frame
8 weeks
Title
Basal dyspnoea (mesured by the dyspnoea area of CRQ questionnaire).
Description
To compare the benefits achieved by both systems in terms of Improvement in basal dyspnea measured by the dyspnoea area of CRQ questionnaire.
Time Frame
8 weeks
Title
Quality of life (SF36 questionnaire).
Description
To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with SF36 questionnarire).
Time Frame
8 weeks
Title
Quality of life (KBILD questionnaire).
Description
To compare the benefits achieved by both systems in terms of Improvement in HRQoL (with KBILD questionnaire).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age > 30 years old
Diagnostic of ILD according to the national and international guidelines 23
Being clinically stable the previous 4 weeks
Acceptance to participate in the trial
Exclusion Criteria:
Have been enrolled in a PR program in the last previous 6 months
Respiratory Diseases other than ILD or severe comorbidities
Osteoarticular diseases which don't allow training
End-stage ILD, treatment with opiates or survival < 6 months
Cognitive alterations that preclude colaboration
12. IPD Sharing Statement
Learn more about this trial
Can High-Flow Oxygen Therapy Improve Oxygenation During Exercise in ILD Patients?
We'll reach out to this number within 24 hrs