Long-term Impact of Pulmonary Rehabilitation

NCT ID: NCT00959855

Last Updated: 2019-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2011-09-30

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.

Detailed Description

The benefits of pulmonary rehabilitation are well documented elsewhere, however, the exact mechanisms responsible for these significant improvements and alteration of the disease progression are unexplained. Also unexplained is the apparent lack of carry over of functional capacity into free-living activities as measured by activity monitors.

There are no reported effects on decreasing level of inflammatory cytokines or C-reactive protein (CRP) post rehabilitation, however, a training response to reactive oxidative stress (ROS) after a moderate intensity pulmonary rehabilitation programme has been reported. As oxidative stress is a catalyst to inflammation, a training response to exercise induced ROS in patients with COPD may also have a secondary effect of modifying inflammation in the stable COPD patient thereby improving patient outcomes.

No studies to-date have combined free-living activities, biomarkers and standard outcome measures in patient's pre and post pulmonary rehabilitation or follow-up patients over a five year period.

Subjects referred to pulmonary rehabilitation who fulfil the GOLD criteria for COPD will be recruited on a rolling basis and randomly allocated to one of two groups. Group 1 (Control), Group 2 (Intervention).

It is a multi-centred, randomised controlled trial using the above convenience sample of patients referred to pulmonary rehabilitation who meet the inclusion/exclusion criteria.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Pulmonary Rehabilitation

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

Group Type: EXPERIMENTAL

Pulmonary Rehabilitation

Intervention Type: 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.

Pulmonary Rehabiliation

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Pulmonary Rehabilitation

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.

Intervention Type: OTHER

Other Intervention Names

Activity Armbands; Inspiratory Muscle Training

Eligibility Criteria

Inclusion Criteria

1. A diagnosis of COPD based on the GOLD staging of the Disease

2. MMRC score of 3 or above

3. Ability to mobilize independently

4. Willing to comply with the home exercise and inspiratory muscle training programmes

5. Willing to wear the SenseWare Armband

6. Optimal medical management

7. No adverse effects to exercise testing

8. Patient's awaiting lung transplant

Exclusion Criteria

1. Evidence of ischemic heart disease/acute changes on ECG

2. Uncontrolled hypertension

3. Insulin dependent diabetes mellitus

4. Uncontrolled CCF / idiopathic cardiomyopathy

5. Reversible Asthma

6. A diagnosis of lung cancer/TB/recent pneumothorax/PE or pneumonia

7. Any musculoskeletal/neurological condition which would render the patient incapable of completing the course

8. Exacerbation of COPD within 4 weeks of program

9. Poor cognitive status

10. Previous attendance at a pulmonary rehabilitation program

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ITS Pulmonary Rehabilitation Research Network

UNKNOWN

Sponsor Role: collaborator

Beaumont Hospital

OTHER

Sponsor Role: lead

Responsible Party

Professor Richard Costello

consultant chest physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Costello, Professor

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hosptial

Locations

Beaumont Hospital

Beaumont, Dublin, Ireland

Countries

Ireland

Other Identifiers

ITS-1-MCT

Identifier Type: -

Identifier Source: org_study_id