search
Back to results

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
Beaumont Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Obstructive Pulmonary Disease focused on measuring Quality of Life, Free-living activity, Exacerbation, Rehabilitation

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beaumont Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control Group

Pulmonary Rehabilitation

Arm Description

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

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

Outcomes

Primary Outcome Measures

Sustained improvement in free-living activities, measured as the average daily METs
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
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
This is a validated field exercise test used to prescribe exercise intensity and determine functional capacity
The Modified Medical Research Council Scale
This questionnaire measures breathlessness on activity
Pulmonary Function Tests
Measurements of forced expiratory volume in 1 second, Forced Vital Capacity, Inspiratory Capacity and peak inspiratory muscle pressure will all be measured
Borg Score
A 10 point scale measurement of breathlessness

Full Information

First Posted
August 18, 2010
Last Updated
February 9, 2012
Sponsor
Beaumont Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01530412
Brief Title
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

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beaumont Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Quality of Life, Free-living activity, Exacerbation, Rehabilitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients are randomized to the control group and are assessed pre rehabilitation and post rehabilitation after which they proceed to the intervention group.
Arm Title
Pulmonary Rehabilitation
Arm Type
Experimental
Arm Description
Patients undergo an active seven week pulmonary rehabilitation programme. Assessments occur pre rehabilitation, post rehabilitation, at three months and at one year.
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
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 Outcome Measure Information:
Title
Sustained improvement in free-living activities, measured as the average daily METs
Description
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.
Time Frame
At the end of 1 year compared to baseline
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Two quality of life questionnaires will be utilized, 1) the St. Georges Disease Questionnaire; a disease specific questionnaire, 2)The generic EuroQol questionnaire
Time Frame
baseline will be compared to that at 1 year follow-up
Title
The Incremental Shuttle Walk Test
Description
This is a validated field exercise test used to prescribe exercise intensity and determine functional capacity
Time Frame
baseline will be compared to that at 1 year follow-up
Title
The Modified Medical Research Council Scale
Description
This questionnaire measures breathlessness on activity
Time Frame
baseline will be compared to that at 1 year follow-up
Title
Pulmonary Function Tests
Description
Measurements of forced expiratory volume in 1 second, Forced Vital Capacity, Inspiratory Capacity and peak inspiratory muscle pressure will all be measured
Time Frame
baseline will be compared to that at 1 year follow-up
Title
Borg Score
Description
A 10 point scale measurement of breathlessness
Time Frame
baseline will be compared to that at 1 year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard W Costello, Professor
Organizational Affiliation
Beaumont Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Brenda M Deering, MSc Physio
Organizational Affiliation
Beaumont Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claire Egan, MSc Physio
Organizational Affiliation
Beaumont Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Niamh M McCormack, MSc Nursing
Organizational Affiliation
Beaumont Hosptial
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beaumont Hospital
City
Beaumont
State/Province
Dublin
ZIP/Postal Code
9
Country
Ireland

12. IPD Sharing Statement

Learn more about this trial

Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

We'll reach out to this number within 24 hrs