Idiopathic Pulmonary Fibrosis
Conditions
Keywords
pulmonary rehabilitation
Brief summary
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.
Detailed description
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).
Interventions
PROCEDUREPulmonary rehabilitation
Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training
Sponsors
Corfu General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
participants are blindly randomized to receive oxygen or not during rehabilitation.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* diagnosis of IPF based on current established criteria * no exacerbation previous 3 months * no participation in such program previous 3 months. * If on treatment with pirfenidone or nintedanib, this will be recorded and patient should be on treatment for at least 3-6 months to achieve stable state.
Exclusion criteria
\- concomitant diagnosis of congestive heart failure and lung cancer.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test Distance (6MWTD) (meters) | 2 months | Statistically significant short term effect on exercise capacity |
| Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) | 2 months | Statistically significant short term effect on health related quality of life |
| Hospital Anxiety and Depression Scale (HADS) (units on scale) | 2 months | Statistically significant short term effect on health related quality of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test Distance (6MWTD) (meters) | 12 months | Statistically significant long term effect on exercise capacity |
| Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) | 12 months | Statistically significant long term effect on health related quality of life |
| Hospital Anxiety and Depression Scale (HADS) (units on scale) | 12 months | Statistically significant long term effect on health related quality of life |
Countries
Greece
Outcome results
None listed