Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Pulmonary rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring pulmonary rehabilitation
Eligibility Criteria
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.
Sites / Locations
- Corfu General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
High flow oxygen supplementation
Oxygen supplementation upon hypoxemia
Arm Description
Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A).
Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B).
Outcomes
Primary Outcome Measures
6 Minute Walk Test Distance (6MWTD) (meters)
Statistically significant short term effect on exercise capacity
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Statistically significant short term effect on health related quality of life
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Statistically significant short term effect on health related quality of life
Secondary Outcome Measures
6 Minute Walk Test Distance (6MWTD) (meters)
Statistically significant long term effect on exercise capacity
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Statistically significant long term effect on health related quality of life
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Statistically significant long term effect on health related quality of life
Full Information
NCT ID
NCT03326089
First Posted
October 17, 2017
Last Updated
August 28, 2023
Sponsor
Corfu General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03326089
Brief Title
Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
Official Title
Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
August 28, 2023 (Actual)
Study Completion Date
August 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corfu General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
pulmonary rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
participants are blindly randomized to receive oxygen or not during rehabilitation.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High flow oxygen supplementation
Arm Type
Active Comparator
Arm Description
Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A).
Arm Title
Oxygen supplementation upon hypoxemia
Arm Type
Placebo Comparator
Arm Description
Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B).
Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation
Other Intervention Name(s)
oxygen supplementation
Intervention Description
Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training
Primary Outcome Measure Information:
Title
6 Minute Walk Test Distance (6MWTD) (meters)
Description
Statistically significant short term effect on exercise capacity
Time Frame
2 months
Title
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Description
Statistically significant short term effect on health related quality of life
Time Frame
2 months
Title
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Description
Statistically significant short term effect on health related quality of life
Time Frame
2 months
Secondary Outcome Measure Information:
Title
6 Minute Walk Test Distance (6MWTD) (meters)
Description
Statistically significant long term effect on exercise capacity
Time Frame
12 months
Title
Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)
Description
Statistically significant long term effect on health related quality of life
Time Frame
12 months
Title
Hospital Anxiety and Depression Scale (HADS) (units on scale)
Description
Statistically significant long term effect on health related quality of life
Time Frame
12 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stefanos Patsiris
Organizational Affiliation
Physiotherapy Director
Official's Role
Study Director
Facility Information:
Facility Name
Corfu General Hospital
City
Corfu
ZIP/Postal Code
49100
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Everything will be published in time.
Learn more about this trial
Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
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