Effects of Pulmonary Rehabilitation on Functional and Health Status Measures in Pulmonary Fibrosis

NCT ID: NCT03542318

Last Updated: 2018-06-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-01
• Study Completion Date: 2016-01-31

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).

Conditions

Pulmonary Fibrosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Active group (Experimental)

Total of 60 patients were enrolled. All patients were referred for PR from the outpatient clinics of the local general hospital. Pulmonary fibrosis was confirmed through a high resonance computed tomography scan and pulmonary function testing. Participants who required modifications to their drug therapy due to exacerbations were excluded from the study. Each participant was classified according to the modified Medical Research Council dyspnoea scale

Pulmonary Rehabilitation

Intervention Type: OTHER

A multidisciplinary PR programme was delivered twice weekly for 12 weeks. Each class was of 2 hours in duration. The first hour had an exercise component. Inspiratory muscle training was carried out using the Respironics IMT Threshold trainer® during the class. Educational sessions covered various aspects of pulmonary fibrosis care and self-management delivered. Patients also received an individualized home exercise programme consisting of exercise similar to what was being carried out during the classes. Each participant was encouraged to perform at least 20 minutes of these exercises per day.

Inactive control group

A total of 60 patients were enrolled in a control group. All were referred for PR from the outpatient clinics of the local general hospital. In this group patients who requested not to carry out the intervention but participate in the investigations were enrolled. 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

No interventions assigned to this group

Interventions

Pulmonary Rehabilitation

A multidisciplinary PR programme was delivered twice weekly for 12 weeks. Each class was of 2 hours in duration. The first hour had an exercise component. Inspiratory muscle training was carried out using the Respironics IMT Threshold trainer® during the class. Educational sessions covered various aspects of pulmonary fibrosis care and self-management delivered. Patients also received an individualized home exercise programme consisting of exercise similar to what was being carried out during the classes. Each participant was encouraged to perform at least 20 minutes of these exercises per day.

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Malta

OTHER

Sponsor Role: lead

Responsible Party

Anabel Sciriha

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anabel Sciriha, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy Department, Faculty of Health Sciences, University of Malta

Locations

Faculty of Health Sciences, Physiotherapy Department

Multiple Locations, , Malta

Countries

Malta

Other Identifiers

191/2011

Identifier Type: -

Identifier Source: org_study_id