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Trial record 23 of 129 for:    Recruiting, Not yet recruiting, Available Studies | "Pulmonary Fibrosis"

Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03326089
Recruitment Status : Recruiting
First Posted : October 30, 2017
Last Update Posted : October 31, 2017
Sponsor:
Information provided by (Responsible Party):
Ilias Papanikolaou, Corfu General Hospital

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
Idiopathic Pulmonary Fibrosis Procedure: Pulmonary rehabilitation Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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 : June 1, 2017
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 2019


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 Name: 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 Name: oxygen supplementation




Primary Outcome Measures :
  1. 6 Minute Walk Test Distance (6MWTD) (meters) [ Time Frame: 2 months ]
    Statistically significant short term effect on exercise capacity

  2. Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) [ Time Frame: 2 months ]
    Statistically significant short term effect on health related quality of life

  3. Hospital Anxiety and Depression Scale (HADS) (units on scale) [ Time Frame: 2 months ]
    Statistically significant short term effect on health related quality of life


Secondary Outcome Measures :
  1. 6 Minute Walk Test Distance (6MWTD) (meters) [ Time Frame: 12 months ]
    Statistically significant long term effect on exercise capacity

  2. Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale) [ Time Frame: 12 months ]
    Statistically significant long term effect on health related quality of life

  3. Hospital Anxiety and Depression Scale (HADS) (units on scale) [ Time Frame: 12 months ]
    Statistically significant long term effect on health related quality of life



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326089


Contacts
Contact: Ilias Papanikolaou 00306974305925 icpapanikolaou@hotmail.com

Locations
Greece
Corfu General Hospital Recruiting
Corfu, Greece, 49100
Contact: Ilias Papanikolaou         
Sponsors and Collaborators
Corfu General Hospital
Investigators
Study Director: Stefanos Patsiris Physiotherapy Director

Responsible Party: Ilias Papanikolaou, Consultant Pulmonary Physician, Corfu General Hospital
ClinicalTrials.gov Identifier: NCT03326089     History of Changes
Other Study ID Numbers: CorfuGH569
First Posted: October 30, 2017    Key Record Dates
Last Update Posted: October 31, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Everything will be published in time.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ilias Papanikolaou, Corfu General Hospital:
pulmonary rehabilitation

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial