Clinical trial NCT03542318: Effects of Pulmonary Rehabilitation on Functional and Health Status Measures in Pulmonary Fibrosis
Official title: Effects of a Pulmonary Rehabilitation Programme on Functional and Health Status Measures in Patients With Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
Keywords: Pulmonary Rehabilitation
Functional outcomes
Health Status
Exercise
Lead sponsor: University of Malta
Sponsor class: OTHER
First posted: 2018-05-31
Enrollment: 120
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 120 patients were enrolled: 60 patients formed part of the active group (30 male and 30 female), another 60 patients were enrolled in an inactive, control group, 32 of which were male and 28 female participants.

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).

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

Primary outcomes:
measure: 6 minute walk test
timeFrame: The 6MWD shall be measures at baseline and on completion of the programme at 12weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression score
timeFrame: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks
measure: St George's Respiratory Questionnaire
timeFrame: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Malta
facility: Faculty of Health Sciences, Physiotherapy Department
Study officials:
affiliation: Physiotherapy Department, Faculty of Health Sciences, University of Malta
name: Anabel Sciriha, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: