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Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Sponsor
Corfu General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03326089
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
63
Anticipated Duration (Months)
0.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Pulmonary rehabilitation
 N/A

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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
participants are blindly randomized to receive oxygen or not during rehabilitation.
Primary Purpose:
Treatment
Official Title:
Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis
Actual Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Feb 1, 2021
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: High flow oxygen supplementation

Pulmonary rehabilitation with constant high flow supplementary oxygen supply FiO2 50% for 2 months (Group A).

Procedure: Pulmonary rehabilitation
Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training
Other Names:
  • oxygen supplementation

    		•
    Placebo Comparator: Oxygen supplementation upon hypoxemia

    Pulmonary rehabilitation without oxygen supply unless upon resting or exercise induced hypoxemia for 2 months (Group B).

    Procedure: Pulmonary rehabilitation
    Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training
    Other Names:
  • oxygen supplementation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 6 Minute Walk Test Distance (6MWTD) (meters) [2 months]

      Statistically significant short term effect on exercise capacity

    2. 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

    3. Hospital Anxiety and Depression Scale (HADS) (units on scale) [2 months]

      Statistically significant short term effect on health related quality of life

    Secondary Outcome Measures

    1. 6 Minute Walk Test Distance (6MWTD) (meters) [12 months]

      Statistically significant long term effect on exercise capacity

    2. 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

    3. Hospital Anxiety and Depression Scale (HADS) (units on scale) [12 months]

      Statistically significant long term effect on health related quality of life

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Corfu General Hospital Corfu Greece 49100

    Sponsors and Collaborators

    • Corfu General Hospital

    Investigators

    • Study Director: Stefanos Patsiris, Physiotherapy Director

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ilias Papanikolaou, Consultant Pulmonary Physician, Corfu General Hospital
    ClinicalTrials.gov Identifier:
    NCT03326089
    Other Study ID Numbers:
    • CorfuGH569
    First Posted:
    Oct 30, 2017
    Last Update Posted:
    Jan 28, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ilias Papanikolaou, Consultant Pulmonary Physician, Corfu General Hospital
    pulmonary rehabilitation
    Additional relevant MeSH terms:
    Pulmonary Fibrosis
    Idiopathic Pulmonary Fibrosis
    Fibrosis

    Study Results

    No Results Posted as of Jan 28, 2021