ClinicalTrials.gg
CompletedNCT03729583Updated Nov 2, 2018

The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases

An interventional study of Pulmonary Rehabilitation in Interstitial Lung Disease, sponsored by University of Malta. Completed at 1 site in Malta. Per ClinicalTrials.gov, last updated 2018-11-02.

Sponsored by University of Malta · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 3 months after the study started (first participant enrolled Jul 2017, registered Oct 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Sex
All
01

Study summary

Breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (COPD) patients. Evidence regarding the effects of such an intervention in ILD patients is though lacking. In view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ILD patients.

Read the detailed description

One of the commonest symptoms experienced in patients with a diagnosis of interstitial lung disease (ILD) is shortness of breath, a symptom which greatly affects their abilities to carry out activities of daily living. Breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (COPD) patients. Evidence regarding the effects of such an intervention in ILD patients is though lacking. In view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ILD patients. Twenty Seven ILD patients were randomly distributed to either the control group (n=15) which received a 12-week Pulmonary Rehabilitation (PR) programme without breathing retraining or the active group (n=12) which received a 12-week PR programme with breathing retraining. All patients had both the 6-minute walk test and their level of breathlessness assessed using the Dyspnoea Borg scale assessed at baseline and at 4 weekly intervals for a 12-week period throughout the programme.

02

Conditions studied

  • Interstitial Lung Disease
03

In context

Lung Diseases, Interstitial

680 studies on the registry are indexed under Lung Diseases, Interstitial; 246 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 384 interventional studies indexed under Lung Diseases, Interstitial.

Browse Lung Diseases, Interstitial studies →

Lead sponsor

University of Malta is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with a confirmed diagnosis of ILD and who were referred for PR

Exclusion criteria

Exclusion Criteria:

  • Patients who had musculoskeletal or neurological conditions affecting the outcome measures
  • Patients who required oxygen therapy and did not accept administration
  • Patients with unstable cardiovascular conditions
  • Patients who were not willing to participate
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Control group

    The control group consisted of 15 patients with a diagnosis of ILD. They received a 12-week Pulmonary Rehabilitation (PR) programme without breathing retraining All patients were medically stable and referred by their caring respiratory consultant

    Behavioral: Pulmonary Rehabilitation

  • Experimental
    Active group

    The active group consisted of 15 patients with a diagnosis of ILD. They received a 12-week Pulmonary Rehabilitation (PR) programme with breathing retraining exercises. All patients were medically stable and referred by their caring respiratory consultant

    Behavioral: Pulmonary Rehabilitation

Interventions

  • BehavioralPulmonary Rehabilitation

    A 12 week high intensity PR programme was delivered to both groups. The active group had additional breathing control interventions and exercises

    Also known as: Respiratory Rehabilitation

06

What researchers measure

Primary outcomes

  1. 6 minute walk test

    A walk test to examine exercise endurance

    Time frame: Change in walking distance from baseline to 12weeks

Secondary outcomes

  1. Dyspnoea score

    Borg scale

    Time frame: Change in dyspnoea measures from baseline to 12weeks

07

Study locations

1 site
  • Melanie Axiak
    Mosta, Malta
08

References and documents

Individual participant data

Plan to share: No — All data will be provided in the publication

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03729583
Lead sponsor
University of Malta
Responsible party
Melanie Axiak (Principal Investigator, University of Malta) — Principal investigator
First posted
Nov 2, 2018
Start date
Jul 1, 2017
Primary completion
Nov 30, 2017
Completion
May 18, 2018
Last update
Nov 2, 2018

Study contacts

Melanie Axiak, BSc
principal investigator · University of Malta

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion