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Completed

NCT Number: NCT03326089

Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Corfu General Hospital

Corfu, 49100, Greece

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary rehabilitation

Procedure

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

Other names: oxygen supplementation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Corfu General Hospital

Other

Registry information

Official study title

Short and Long-term Effects of Oxygen Supplemented Pulmonary Rehabilitation in Idiopathic Pulmonary Fibrosis

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2017
Registry last updated
Aug 30, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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