The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Not Applicable
Locations
Malta
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease
Eligibility 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
Sites / Locations
- Melanie Axiak
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Active group
Arm Description
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
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
Outcomes
Primary Outcome Measures
6 minute walk test
A walk test to examine exercise endurance
Secondary Outcome Measures
Dyspnoea score
Borg scale
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03729583
Brief Title
The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases
Official Title
The Effects of Breathing Retraining on Dyspnoea Measures and the Six-Minute Walking Distance in Patients With Interstitial Lung Diseases
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
November 30, 2017 (Actual)
Study Completion Date
May 18, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Malta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Active group
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Pulmonary Rehabilitation
Other Intervention Name(s)
Respiratory Rehabilitation
Intervention Description
A 12 week high intensity PR programme was delivered to both groups. The active group had additional breathing control interventions and exercises
Primary Outcome Measure Information:
Title
6 minute walk test
Description
A walk test to examine exercise endurance
Time Frame
Change in walking distance from baseline to 12weeks
Secondary Outcome Measure Information:
Title
Dyspnoea score
Description
Borg scale
Time Frame
Change in dyspnoea measures from baseline to 12weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melanie Axiak, BSc
Organizational Affiliation
University of Malta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Melanie Axiak
City
Mosta
Country
Malta
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
All data will be provided in the publication
Learn more about this trial
The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases
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