Effects of Pulmonary Rehabilitation on Functional and Health Status Measures in Pulmonary Fibrosis
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|ClinicalTrials.gov Identifier: NCT03542318|
Recruitment Status : Completed
First Posted : May 31, 2018
Last Update Posted : June 5, 2018
|Condition or disease||Intervention/treatment|
|Pulmonary Fibrosis||Other: Pulmonary Rehabilitation|
|Study Type :||Observational|
|Actual Enrollment :||120 participants|
|Official Title:||Effects of a Pulmonary Rehabilitation Programme on Functional and Health Status Measures in Patients With Pulmonary Fibrosis|
|Actual Study Start Date :||March 1, 2014|
|Actual Primary Completion Date :||January 31, 2016|
|Actual Study Completion Date :||January 31, 2016|
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
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
- 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.
- Hospital Anxiety and Depression score [ Time Frame: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks ]The HAD scale was specifically developed for recognition of anxiety and depression in patients with somatic conditions. It is a validated tool which explores the symptom severity in patient with chronic diseases who have anxiety and depressive related signs. The HAD scale is divided into an anxiety (HADS-A) and a depression subscale (HADS-D) both of which contain seven items, rated 0-3, with the highest possible score for both domains being that of 21. Scores less than 8 indicate no clinical distress; scores between 8 to 10 indicate possible psychiatric morbidity and scores of 11 or more indicate pathologic levels of distress.
- St George's Respiratory Questionnaire [ Time Frame: This outcome shall be measured at baseline and on completion of the PR programme at 12weeks ]The SGRQ is a widely used questionnaire to assess health related quality of life, due to its specificity to respiratory diseases. This questionnaire consists of 50 items, separated into three domains: symptoms, activity and impact domains. Scores range from 0 to l00 for the three subscales with a summary total score. Higher scores indicate worse health status; 0 indicates no impairment and 100 indicates maximal impairment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03542318
|Faculty of Health Sciences, Physiotherapy Department|
|Multiple Locations, Malta, MSD 2080|
|Principal Investigator:||Anabel Sciriha, Ph.D||Physiotherapy Department, Faculty of Health Sciences, University of Malta|