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This is an interventional double-blind randomized controlled trial, to investigate the short and long-term effects of a supervised exercise training program in patients with IPF, depending on alternate patterns of oxygen supplementation during PR.
The investigators hypothesize that PR service with supplemented oxygen supply regardless of hypoxemia may have significantly better short-term effects in patients with IPF. The study will take place in Corfu General Hospital, by the Departments of Pulmonary Medicine and Physiotherapy and Rehabilitation, respectively. Study participants will be divided in two equal arms 1:1 in a double-blind manner. One of the investigators blinded to their clinical data will assign each participant to PR service either i) with constant supplementary oxygen supply FiO2 50% regardless of saturation status Group A) or ii) without oxygen supply unless upon resting or exercise induced hypoxemia (saturation <88%) (Group B).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High flow oxygen supplementation | Active Comparator | Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A). |
|
| Oxygen supplementation upon hypoxemia | Placebo Comparator | Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulmonary rehabilitation | Procedure | Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test Distance (6MWTD) (meters) | Statistically significant short term effect on exercise capacity | 2 months |
| Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) | Statistically significant short term effect on health related quality of life | 2 months |
| Hospital Anxiety and Depression Scale (HADS) (units on scale) | Statistically significant short term effect on health related quality of life | 2 months |
| Measure | Description | Time Frame |
|---|---|---|
| 6 Minute Walk Test Distance (6MWTD) (meters) | Statistically significant long term effect on exercise capacity | 12 months |
| Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) |
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Inclusion Criteria:
Exclusion Criteria:
- concomitant diagnosis of congestive heart failure and lung cancer.
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| Name | Affiliation | Role |
|---|---|---|
| Stefanos Patsiris | Physiotherapy Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Corfu General Hospital | Corfu | 49100 | Greece |
Everything will be published in time.
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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participants are blindly randomized to receive oxygen or not during rehabilitation.
|
Statistically significant long term effect on health related quality of life
| 12 months |
| Hospital Anxiety and Depression Scale (HADS) (units on scale) | Statistically significant long term effect on health related quality of life | 12 months |