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

NCT03542318 | Completed

• 1 other identifier: 191/2011
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Fibrosis

Keywords

Pulmonary Rehabilitation; Functional outcomes; Health Status; Exercise

Outcome Measures

Primary Outcomes (1)

• 6 minute walk test

  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.

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

Secondary Outcomes (2)

• 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 Arms (2)

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

Other: Pulmonary Rehabilitation

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

Interventions

Pulmonary Rehabilitation 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.

Active group (Experimental)

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Malta: lead

Study Sites (1)

Faculty of Health Sciences, Physiotherapy Department

Multiple Locations, MSD 2080, Malta

Location

MeSH Terms

Conditions

Pulmonary Fibrosis; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Anabel Sciriha, Ph.D

  Physiotherapy Department, Faculty of Health Sciences, University of Malta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2018
• First Posted: May 31, 2018
• Study Start: March 1, 2014
• Primary Completion: January 31, 2016
• Study Completion: January 31, 2016
• Last Updated: June 6, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)