NCT03326089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 30, 2017

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

August 30, 2023

Status Verified

August 1, 2023

Enrollment Period

6.2 years

First QC Date

October 17, 2017

Last Update Submit

August 28, 2023

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

pulmonary rehabilitation

Outcome Measures

Primary Outcomes (3)

  • 6 Minute Walk Test Distance (6MWTD) (meters)

    Statistically significant short term effect on exercise capacity

    2 months

  • Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)

    Statistically significant short term effect on health related quality of life

    2 months

  • Hospital Anxiety and Depression Scale (HADS) (units on scale)

    Statistically significant short term effect on health related quality of life

    2 months

Secondary Outcomes (3)

  • 6 Minute Walk Test Distance (6MWTD) (meters)

    12 months

  • Saint-George Respiratory Questionnaire Idiopathic Pulmonary Fibrosis Version (SGRQ-I) (units on scale)

    12 months

  • Hospital Anxiety and Depression Scale (HADS) (units on scale)

    12 months

Study Arms (2)

High flow oxygen supplementation

ACTIVE COMPARATOR

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

Procedure: Pulmonary rehabilitation

Oxygen supplementation upon hypoxemia

PLACEBO COMPARATOR

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

Procedure: Pulmonary rehabilitation

Interventions

Pulmonary rehabilitationPROCEDURE

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

Also known as: oxygen supplementation
High flow oxygen supplementationOxygen supplementation upon hypoxemia

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • \- concomitant diagnosis of congestive heart failure and lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Corfu General Hospital

Corfu, 49100, Greece

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stefanos Patsiris

    Physiotherapy Director

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
participants are blindly randomized to receive oxygen or not during rehabilitation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Pulmonary Physician

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 30, 2017

Study Start

June 1, 2017

Primary Completion

August 28, 2023

Study Completion

August 28, 2023

Last Updated

August 30, 2023

Record last verified: 2023-08

Locations

GR(1)