The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases

The Effects of Breathing Retraining on Dyspnoea Measures and the Six-Minute Walking Distance in Patients With Interstitial Lung Diseases

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Behavioral: Pulmonary Rehabilitation

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malta
  • Mosta, Malta
    • Melanie Axiak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
6 minute walk test	A walk test to examine exercise endurance	Change in walking distance from baseline to 12weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dyspnoea score	Borg scale	Change in dyspnoea measures from baseline to 12weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Actual): November 30, 2017
• Study Completion (Actual): May 18, 2018

Study Registration Dates

• First Submitted: October 31, 2018
• First Submitted That Met QC Criteria: November 1, 2018
• First Posted (Actual): November 2, 2018

Study Record Updates

• Last Update Posted (Actual): November 2, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: MAxiak

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All data will be provided in the publication

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No