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Clinical Trials/NCT03542318
NCT03542318
Completed
Not Applicable

Effects of a Pulmonary Rehabilitation Programme on Functional and Health Status Measures in Patients With Pulmonary Fibrosis

University of Malta1 site in 1 country120 target enrollmentMarch 1, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Fibrosis
Sponsor
University of Malta
Enrollment
120
Locations
1
Primary Endpoint
6 minute walk test
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis.

Detailed Description

The inclusion of Pulmonary Rehabilitation (PR) as part of the management of pulmonary fibrosis although being highly recommended and recommended in guidelines still sees studies exploring the outcomes from such an intervention limited. The present study aims to contribute to the available literature by investigating the effects of a high intensity, 12week PR programme on functional and quality of life measures in patients with a diagnosis of pulmonary fibrosis. This study reports outcomes of an observational, quasi experimental type of study. A total of 120 participants were recruited: 60 patients formed part of the active group, another 60 patients were enrolled in an inactive group. Each participant was classified according to the modified Medical Research Council dyspnoea scale and placed in one of 5 categories (0 to 4) according to self-perceived breathlessness during daily activities. The following outcomes were measured: Lung function tests including plethysmography and diffusion capacity of carbon monoxide (DLCO), functional tests (6-minute walking test, Dyspnoea Borg Scale) and Health status measures (St George's Respiratory Questionnaire and HAD score).

Registry
clinicaltrials.gov
Start Date
March 1, 2014
End Date
January 31, 2016
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Anabel Sciriha

Principal Investigator

University of Malta

Eligibility Criteria

Inclusion Criteria

  • Patients with a confirmed diagnosis of Pulmonary Fibrosis
  • Patients had to be medically stable to participate in such a programme

Exclusion Criteria

  • Any orthopaedic or neurological condition affecting mobility
  • If they required oxygen therapy this had to be used

Outcomes

Primary Outcomes

6 minute walk test

Time Frame: The 6MWD shall be measures at baseline and on completion of the programme at 12weeks

The six-minute walking distance test (6MWD) was performed according to the American Thoracic Society guidelines (ATS Committee on Proficiency Standards for Clinical Pulmonary Function Laboratories 2002). Each patient was instructed to walk as rapidly as possible in a 30-meter corridor for the time of this test. The test was repeated twice with an interval of 30 minutes. The longest distance on a 6MWT and oxygen saturation were utilized to measure exercise capacity. Dyspnoea was scored using the Borg Category Ratio Scale (Borg 1982) measuring dyspnoea symptoms before and after the test.

Secondary Outcomes

  • Hospital Anxiety and Depression score(This outcome shall be measured at baseline and on completion of the PR programme at 12weeks)
  • St George's Respiratory Questionnaire(This outcome shall be measured at baseline and on completion of the PR programme at 12weeks)

Study Sites (1)

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