Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

NCT ID: NCT01530412

Last Updated: 2012-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2010-07-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Control Group

Patients are randomized to the control group and are assessed pre rehabilitation and post rehabilitation after which they proceed to the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Pulmonary Rehabilitation

Patients undergo an active seven week pulmonary rehabilitation programme. Assessments occur pre rehabilitation, post rehabilitation, at three months and at one year.

Group Type: EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type: OTHER

Patients undergo pulmonary rehabilitation for two hours twice a week for seven weeks. The first hour comprises of an individualized exercise programme and the second hour consists of an educational component. Patients are also required to undergo inspiratory muscle training five days a week for thirty minutes and exercise for an additional three days a week for thirty minutes.

Interventions

Pulmonary Rehabilitation

Patients undergo pulmonary rehabilitation for two hours twice a week for seven weeks. The first hour comprises of an individualized exercise programme and the second hour consists of an educational component. Patients are also required to undergo inspiratory muscle training five days a week for thirty minutes and exercise for an additional three days a week for thirty minutes.

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Richard Costello

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard W Costello, Professor

Role: STUDY_CHAIR

Beaumont Hospital

Brenda M Deering, MSc Physio

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Claire Egan, MSc Physio

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Niamh M McCormack, MSc Nursing

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hosptial

Locations

Beaumont Hospital

Beaumont, Dublin, Ireland

Countries

Ireland

Other Identifiers

RCT-3-LTE

Identifier Type: -

Identifier Source: org_study_id