Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Richard Costello, Beaumont Hospital
ClinicalTrials.gov Identifier:
NCT01530412
First received: August 18, 2010
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Other: Pulmonary Rehabilitation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation: 1 Year Follow-up

Resource links provided by NLM:


Further study details as provided by Beaumont Hospital:

Primary Outcome Measures:
  • Sustained improvement in free-living activities, measured as the average daily METs [ Time Frame: At the end of 1 year compared to baseline ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Quality of Life [ Time Frame: baseline will be compared to that at 1 year follow-up ] [ Designated as safety issue: No ]
    Two quality of life questionnaires will be utilized, 1) the St. Georges Disease Questionnaire; a disease specific questionnaire, 2)The generic EuroQol questionnaire

  • The Incremental Shuttle Walk Test [ Time Frame: baseline will be compared to that at 1 year follow-up ] [ Designated as safety issue: No ]
    This is a validated field exercise test used to prescribe exercise intensity and determine functional capacity

  • The Modified Medical Research Council Scale [ Time Frame: baseline will be compared to that at 1 year follow-up ] [ Designated as safety issue: No ]
    This questionnaire measures breathlessness on activity

  • Pulmonary Function Tests [ Time Frame: baseline will be compared to that at 1 year follow-up ] [ Designated as safety issue: No ]
    Measurements of forced expiratory volume in 1 second, Forced Vital Capacity, Inspiratory Capacity and peak inspiratory muscle pressure will all be measured

  • Borg Score [ Time Frame: baseline will be compared to that at 1 year follow-up ] [ Designated as safety issue: No ]
    A 10 point scale measurement of breathlessness


Enrollment: 65
Study Start Date: June 2007
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 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.
Experimental: Pulmonary Rehabilitation
Patients undergo an active seven week pulmonary rehabilitation programme. Assessments occur pre rehabilitation, post rehabilitation, at three months and at one year.
Other: 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.

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

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01530412

Locations
Ireland
Beaumont Hospital
Beaumont, Dublin, Ireland, 9
Sponsors and Collaborators
Beaumont Hospital
Investigators
Study Chair: Richard W Costello, Professor Beaumont Hospital
Principal Investigator: Brenda M Deering, MSc Physio Beaumont Hospital
Principal Investigator: Claire Egan, MSc Physio Beaumont Hospital
Principal Investigator: Niamh M McCormack, MSc Nursing Beaumont Hosptial
  More Information

No publications provided

Responsible Party: Professor Richard Costello, Professor of Medicine, Beaumont Hospital
ClinicalTrials.gov Identifier: NCT01530412     History of Changes
Other Study ID Numbers: RCT-3-LTE
Study First Received: August 18, 2010
Last Updated: February 9, 2012
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by Beaumont Hospital:
Quality of Life
Free-living activity
Exacerbation
Rehabilitation

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 19, 2014