Skip to main content
OpenTrials
Completed

NCT Number: NCT01530412

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beaumont Hospital

Beaumont, Dublin, 9, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

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.

Primary outcomes

  1. Sustained improvement in free-living activities, measured as the average daily METs

    Time frame: At the end of 1 year compared to baseline

    Using an accelerometer, which will be worn by patients for seven consecutive days at each time frame, daily average measurements of the number of steps per day, total energy expenditure and METs that will be broken down into sedentary, moderate and vigorous, plus sleep time and efficiency.

Secondary outcomes

  1. Quality of Life

    Time frame: baseline will be compared to that at 1 year follow-up

    Two quality of life questionnaires will be utilized, 1) the St. Georges Disease Questionnaire; a disease specific questionnaire, 2)The generic EuroQol questionnaire

  2. The Incremental Shuttle Walk Test

    Time frame: baseline will be compared to that at 1 year follow-up

    This is a validated field exercise test used to prescribe exercise intensity and determine functional capacity

  3. The Modified Medical Research Council Scale

    Time frame: baseline will be compared to that at 1 year follow-up

    This questionnaire measures breathlessness on activity

  4. Pulmonary Function Tests

    Time frame: baseline will be compared to that at 1 year follow-up

    Measurements of forced expiratory volume in 1 second, Forced Vital Capacity, Inspiratory Capacity and peak inspiratory muscle pressure will all be measured

  5. Borg Score

    Time frame: baseline will be compared to that at 1 year follow-up

    A 10 point scale measurement of breathlessness

Sponsors and collaborators

Lead sponsor

Beaumont Hospital

Other

Registry information

Official study title

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 10, 2012
Registry last updated
Feb 10, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.