Learn about Research & Clinical Trials

Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03326089
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Corfu General Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stefanos Patsiris
Principal Investigator Affiliation Physiotherapy Director
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Greece
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

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).

Arms & Interventions

Arms

Active Comparator: High flow oxygen supplementation

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

Placebo Comparator: Oxygen supplementation upon hypoxemia

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

Interventions

Procedure: - Pulmonary rehabilitation

Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Corfu General Hospital, Corfu, Greece

Status

Recruiting

Address

Corfu General Hospital

Corfu, , 49100

Site Contact

Ilias Papanikolaou

icpapanikolaou@hotmail.com

00306974305925