The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases

NCT03729583 | Completed DMC

• 1 other identifier: MAxiak
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test

  A walk test to examine exercise endurance

  Change in walking distance from baseline to 12weeks

Secondary Outcomes (1)

• Dyspnoea score

  Change in dyspnoea measures from baseline to 12weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Active group

EXPERIMENTAL

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

Interventions

Pulmonary Rehabilitation BEHAVIORAL

A 12 week high intensity PR programme was delivered to both groups. The active group had additional breathing control interventions and exercises

Also known as: Respiratory Rehabilitation

Active group; Control group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of ILD and who were referred for PR

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Malta: lead

Study Sites (1)

Melanie Axiak

Mosta, Malta

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Melanie Axiak, BSc

  University of Malta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 31, 2018
• First Posted: November 2, 2018
• Study Start: July 1, 2017
• Primary Completion: November 30, 2017
• Study Completion: May 18, 2018
• Last Updated: November 2, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)