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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

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE November 2, 2018
Last Update Posted Date November 2, 2018
Actual Study Start Date  ICMJE July 1, 2017
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
6 minute walk test [ Time Frame: Change in walking distance from baseline to 12weeks ]
A walk test to examine exercise endurance
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Dyspnoea score [ Time Frame: Change in dyspnoea measures from baseline to 12weeks ]
Borg scale
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases
Official Title  ICMJE The Effects of Breathing Retraining on Dyspnoea Measures and the Six-Minute Walking Distance in Patients With Interstitial Lung Diseases
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Interstitial Lung Disease
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: 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
    Intervention: Behavioral: Pulmonary Rehabilitation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 1, 2018)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 18, 2018
Actual Primary Completion Date November 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Malta
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03729583
Other Study ID Numbers  ICMJE MAxiak
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: All data will be provided in the publication
Responsible Party Melanie Axiak, University of Malta
Study Sponsor  ICMJE University of Malta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Melanie Axiak, BSc University of Malta
PRS Account University of Malta
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP