Long-term Impact of Pulmonary Rehabilitation

NCT00959855 | Completed

• 1 other identifier: ITS-1-MCT
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study has been designed to capture a large group of patients who undergo pulmonary rehabilitation and map their progression over a 5 year time-frame. The outcome measures have been chosen to capture physiological, functional capacity, free-living activities plus admission and exacerbation rates thereby enhancing our understanding of the potential effects exercise and self management techniques may have on the disease progression. Pulmonary rehabilitation has not been shown to reduce inflammation; therefore, unlike acute exacerbation's where a decrease in inflammation indicates recovery, the exact mechanisms responsible for improvement during pulmonary rehabilitation are as yet unknown.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Pulmonary Rehabilitation; Inflammation; Oxidative Stress; Steps; Free Living Activities; Exacerbation

Outcome Measures

Primary Outcomes (1)

• Quality of life score

  St George's quality of life score at the end of one year will be compared between those who underwent rehabilitaion and those who were in the control non intervention group.

  One year

Secondary Outcomes (2)

• Spiromtery

  12 months

• Number of exacerbations of COPD.

  over one year

Study Arms (2)

Pulmonary Rehabilitation

EXPERIMENTAL

Pulmonary rehabilitation classes based on the British Thoracic Society guidelines will be undertaken for two hours for 16 sessions within an eight week period.

Other: Pulmonary Rehabilitation

Pulmonary Rehabiliation

NO INTERVENTION

The control group will be assessed in the same time frame without participating in the rehabilitation class. They will avail of the next available class after the 12 month assessment.

Interventions

Pulmonary Rehabilitation OTHER

Sixteen, two hourly pulmonary rehabilitation sessions over an eight week period. The first hour will consist of an individualized exercise programme based on exercise field tests. The second hour will consist of an educational component. A home exercise programme of inspiratory muscle training (Threshold(R)IMT (respiratory muscle trainer re:HS730EU-001 single patient use) starting between 15% -30% of PiMax and progress weekly to 60% for 30 mins a day/ 5 dats a week with an inspiratory/expiratory ratio of 3:4. Patients will also be encouraged to walk or undertake an home exercise programme based on a Borg score of between 3 and 5 an additional 3 days a week.

Also known as: Activity Armbands, Inspiratory Muscle Training

Pulmonary Rehabilitation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• A diagnosis of COPD based on the GOLD staging of the Disease
• MMRC score of 3 or above
• Ability to mobilize independently
• Willing to comply with the home exercise and inspiratory muscle training programmes
• Willing to wear the SenseWare Armband
• Optimal medical management
• No adverse effects to exercise testing
• Patient's awaiting lung transplant

You may not qualify if:

• Evidence of ischemic heart disease/acute changes on ECG
• Uncontrolled hypertension
• Insulin dependent diabetes mellitus
• Uncontrolled CCF / idiopathic cardiomyopathy
• Reversible Asthma
• A diagnosis of lung cancer/TB/recent pneumothorax/PE or pneumonia
• Any musculoskeletal/neurological condition which would render the patient incapable of completing the course
• Exacerbation of COPD within 4 weeks of program
• Poor cognitive status
• Previous attendance at a pulmonary rehabilitation program

Sponsors & Collaborators

• Beaumont Hospital: lead
• ITS Pulmonary Rehabilitation Research Network: collaborator

Study Sites (1)

Beaumont Hospital

Beaumont, Dublin, 9, Ireland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Inflammation

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 Costello, Professor

  Beaumont Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant chest physician

Study Record Dates

• First Submitted: August 14, 2009
• First Posted: August 17, 2009
• Study Start: September 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2011
• Last Updated: July 23, 2019

Record last verified: 2019-07

Locations

IE (1)