Long Term Evaluation of Activity Levels Post Pulmonary Rehabilitation

NCT01530412 | Completed

• 1 other identifier: RCT-3-LTE
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Quality of Life; Free-living activity; Exacerbation; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of 1 year compared to baseline

Secondary Outcomes (5)

• Quality of Life

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

• The Incremental Shuttle Walk Test

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

• The Modified Medical Research Council Scale

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

• Pulmonary Function Tests

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

• Borg Score

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

Study Arms (2)

Control Group

NO INTERVENTION

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

Pulmonary Rehabilitation

EXPERIMENTAL

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

Interventions

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.

Pulmonary Rehabilitation

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beaumont Hospital: lead

Study Sites (1)

Beaumont Hospital

Beaumont, Dublin, 9, Ireland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Richard W Costello, Professor

  Beaumont Hospital

  STUDY CHAIR

• Brenda M Deering, MSc Physio

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

• Claire Egan, MSc Physio

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

• Niamh M McCormack, MSc Nursing

  Beaumont Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 18, 2010
• First Posted: February 10, 2012
• Study Start: June 1, 2007
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 10, 2012

Record last verified: 2012-02

Locations

IE (1)