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The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases

Sponsor
University of Malta (Other)
Overall Status
Completed
CT.gov ID
NCT03729583
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
10.5
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Pulmonary Rehabilitation
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Effects of Breathing Retraining on Dyspnoea Measures and the Six-Minute Walking Distance in Patients With Interstitial Lung Diseases
Actual Study Start Date :
Jul 1, 2017
Actual Primary Completion Date :
Nov 30, 2017
Actual Study Completion Date :
May 18, 2018

Arms and Interventions

Arm Intervention/Treatment
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
A 12 week high intensity PR programme was delivered to both groups. The active group had additional breathing control interventions and exercises
Other Names:
  • Respiratory 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
    A 12 week high intensity PR programme was delivered to both groups. The active group had additional breathing control interventions and exercises
    Other Names:
  • Respiratory Rehabilitation

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 6 minute walk test [Change in walking distance from baseline to 12weeks]

      A walk test to examine exercise endurance

    Secondary Outcome Measures

    1. Dyspnoea score [Change in dyspnoea measures from baseline to 12weeks]

      Borg scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients with a confirmed diagnosis of ILD and who were referred for PR
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Melanie Axiak Mosta Malta

    Sponsors and Collaborators

    • University of Malta

    Investigators

    • Principal Investigator: Melanie Axiak, BSc, University of Malta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Melanie Axiak, Principal Investigator, University of Malta
    ClinicalTrials.gov Identifier:
    NCT03729583
    Other Study ID Numbers:
    • MAxiak
    First Posted:
    Nov 2, 2018
    Last Update Posted:
    Nov 2, 2018
    Last Verified:
    Nov 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Diseases
    Lung Diseases, Interstitial

    Study Results

    No Results Posted as of Nov 2, 2018