Clinical trial NCT01530412: Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation
Official title: Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Quality of Life
Free-living activity
Exacerbation
Rehabilitation
Lead sponsor: Beaumont Hospital
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 65
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* A diagnosis of COPD based on the GOLD staging of the disease
* Referred to pulmonary rehabilitation by a respiratory consultant or member of the COPD Team
* Modified Medical Research Council Score of 3 or above
* Ability to mobilize independently
* Motivated to exercise independently

Exclusion Criteria:

* No evidence of COPD on spirometry
* Acute exacerbation within the last 4-6 weeks
* Evidence of ischemic heart disease/acute changes on ECG
* Uncontrolled hypertension
* Insulin dependent diabetes mellitus
* Inability to exercise independently or musculoskeletal/neurological conditions which would prevent completion of the course
* Lung cancer previous attendance at pulmonary rehabilitation

Primary outcomes:
measure: Sustained improvement in free-living activities, measured as the average daily METs
timeFrame: At the end of 1 year compared to baseline
Secondary outcomes:
measure: Quality of Life
timeFrame: baseline will be compared to that at 1 year follow-up
measure: The Incremental Shuttle Walk Test
timeFrame: baseline will be compared to that at 1 year follow-up
measure: The Modified Medical Research Council Scale
timeFrame: baseline will be compared to that at 1 year follow-up
measure: Pulmonary Function Tests
timeFrame: baseline will be compared to that at 1 year follow-up
measure: Borg Score
timeFrame: baseline will be compared to that at 1 year follow-up
Other outcomes:
Locations:
city: Beaumont
country: Ireland
facility: Beaumont Hospital
state: Dublin
Study officials:
affiliation: Beaumont Hospital
name: Richard W Costello, Professor
role: STUDY_CHAIR
affiliation: Beaumont Hospital
name: Brenda M Deering, MSc Physio
role: PRINCIPAL_INVESTIGATOR
affiliation: Beaumont Hospital
name: Claire Egan, MSc Physio
role: PRINCIPAL_INVESTIGATOR
affiliation: Beaumont Hosptial
name: Niamh M McCormack, MSc Nursing
role: PRINCIPAL_INVESTIGATOR
References: