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The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases

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ClinicalTrials.gov Identifier: NCT03729583
Recruitment Status : Completed
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Melanie Axiak, University of Malta

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
Interstitial Lung Disease Behavioral: Pulmonary Rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 1, 2017
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : May 18, 2018


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 Name: 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 Name: Respiratory Rehabilitation




Primary Outcome Measures :
  1. 6 minute walk test [ Time Frame: Change in walking distance from baseline to 12weeks ]
    A walk test to examine exercise endurance


Secondary Outcome Measures :
  1. Dyspnoea score [ Time Frame: Change in dyspnoea measures from baseline to 12weeks ]
    Borg scale



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729583


Locations
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Malta
Melanie Axiak
Mosta, Malta
Sponsors and Collaborators
University of Malta
Investigators
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Principal Investigator: Melanie Axiak, BSc University of Malta
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Responsible Party: Melanie Axiak, Principal Investigator, University of Malta
ClinicalTrials.gov Identifier: NCT03729583    
Other Study ID Numbers: MAxiak
First Posted: November 2, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All data will be provided in the publication

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases