Viewing Study NCT01530412


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Study NCT ID: NCT01530412
Status: COMPLETED
Last Update Posted: 2012-02-10
First Post: 2010-08-18
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation
Sponsor: Beaumont Hospital
Organization:

Study Overview

Official Title: Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up
Status: COMPLETED
Status Verified Date: 2012-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Sustained improvement after pulmonary rehabilitation in activity levels as measured by an activity armband.

Pulmonary rehabilitation is utilized to improve exercise capacity, quality of life and prognosis for patients who suffer from chronic obstructive pulmonary disease. There is also strong evidence that supports the use of pulmonary rehabilitation to decrease hospital admissions thereby reducing cost of care. Recent studies suggest that the significant benefits achieved through rehabilitation fade with time and that in order to improve activities of daily living; for example, average daily number of steps, programmes of longer duration are required.

The primary aim of this study is to identify objective sustained improved in activity levels using the SenseWear activity armband after a short-term pulmonary rehabilitation programme. Secondary aims are to determine antibiotic and steroid use pre and post rehabilitation.
Detailed Description: Chronic obstructive pulmonary disease (COPD) is characterised by airflow limitation and by both systemic and airway inflammation. Together these features lead to decreased physical activity which in turn worsens the patient's dyspnoea. In patients with COPD, physical activity levels are low compared to healthy controls and indeed lower than in patients with other chronic conditions such as arthritis and diabetes. For patients with COPD, decreased physical activity and breathlessness are significant predictors of mortality and morbidity. By reversing deconditioning pulmonary rehabilitation using supervised and home exercise programs leads to increased exercise capacity and health quality of life scores. In order for the benefits of pulmonary rehabilitation to be sustained in the long-term it is essential that there is a change in the patient's physical activity in their home life. While practice guidelines recommend that there is transference of exercise to the home setting it is unknown if this happens in reality. Addressing whether there is an increase in physical activity at home after pulmonary rehabilitation is the focus of this study.

Physical activity can be measured in a number of ways, including direct observation, patient diaries and questionnaires, but one of the most successful are the performance based motion sensors such as pedometers and accelerometers. One such performance based motion sensor is the SenseWear accelerometer. The SenseWear has previously been used in patients with COPD, has been shown to be a reliable measure of physical activity performed in this population, other than those using rolators and it is objectively more accurate than questionnaires and diaries. The hypothesis of this study was that pulmonary rehabilitation leads to a sustained improvement in physical activity in patients with COPD. Physical activity was measured by the daily averaged activity recorded with a SenseWear armband at several time points in the year after a course of pulmonary rehabilitation.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: