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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03729583
Other study ID # MAxiak
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 1, 2017
Est. completion date May 18, 2018

Study information

Verified date November 2018
Source University of Malta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date May 18, 2018
Est. primary completion date November 30, 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Malta Melanie Axiak Mosta

Sponsors (1)

Lead Sponsor Collaborator
University of Malta

Country where clinical trial is conducted

Malta, 

Outcome

Type Measure Description Time frame Safety issue
Primary 6 minute walk test A walk test to examine exercise endurance Change in walking distance from baseline to 12weeks
Secondary Dyspnoea score Borg scale Change in dyspnoea measures from baseline to 12weeks
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