Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adam Hill, NHS Lothian
ClinicalTrials.gov Identifier:
NCT00868075
First received: February 19, 2009
Last updated: November 4, 2011
Last verified: November 2011
  Purpose

The aim of our study is to ascertain whether chest physiotherapy + pulmonary rehabilitation is more efficacious than chest physiotherapy alone. The outcomes that will be used to assess effectiveness are relevant in terms of the direct benefit on the patient's health related quality of life.

PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks chest physiotherapy plus pulmonary rehabilitation.


Condition Intervention Phase
Bronchiectasis
Procedure: Chest physiotherapy
Procedure: Chest Physiotherapy + Exercise Program
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

Resource links provided by NLM:


Further study details as provided by NHS Lothian:

Primary Outcome Measures:
  • The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 27
Study Start Date: March 2009
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chest Physiotherapy
Twice daily chest physiotherapy
Procedure: Chest physiotherapy
Twice daily for 8 weeks
Experimental: Chest Physiotherapy + Exercise Program
Chest Physiotherapy + Exercise Program
Procedure: Chest Physiotherapy + Exercise Program
Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks

Detailed Description:

PLANNED STUDY: This randomized study will compare 8 weeks chest physiotherapy with 8 weeks chest physiotherapy plus pulmonary rehabilitation.

PLAN OF INVESTIGATION: Patients will be recruited from NHS Lothian with 15 randomized to chest physiotherapy and 15 to chest physiotherapy plus pulmonary rehabilitation.

Protocols:

Chest physiotherapy Physiotherapy will be aided using a positive pressure airways device (Acapella) that aids sputum expectoration. They will be asked to do 10 breaths, followed by 3 huffs and a cough. This will be repeated 3 times and repeated twice a day. Expected tiime 10-15 minutes twice daily.

Pulmonary rehabiliation Will be an 8-week programme twice a week in hospital with a third session (unsupervised) at home. It will include both cardiovascular training and upper limb and lower limb strengthening exercises.

Each patient will have a baseline exercise test. Calculation of the patient's 80% peak heart rate will be recorded and then used to ensure that patients are working to this level during the pulmonary rehabilitation cardiovascular sections.

The session will include: 5 minute warm up; 10 minutes treadmill; 10 minutes bicycle; 10 minutes stepper; 10 minutes upper limb and lower limb strengthening exercises; 5 minutes cool down.

Throughout the 8-week programme the resistance and intensity of each activity will be increased as they improve.

Following commencement of their first class they will be provided with a diary for a walking programme at home, which they will do once a week unsupervised.

Endpoints: Assessments below will be done at baseline, 4 weeks, 8 weeks and 3 months.

Microbiology: A fresh sputum sample will be submitted for micobiological culture.

Systemic inflammatory markers: 10mls venous blood for full blood count, erythrocyte sedimentation rate, C reactive protein, urea, electrolytes and liver function tests.

Pulmonary physiology: Pre bronchodilator spirometry (FEV1, FVC and FEV1/FVC), mouth pressures, followed by an incremental shuttle walk test.

24 hour sputum volume: This will be collected the day before each clinic visit. Sputum colour: Graded as mucoid, mucopurulent or purulent. Health related quality of life: Leicester Cough Questionnaire and St George's Respiratory Questionnaire.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with moderate and severe bronchiectasis aged 18-75 will be recruited. Severity will be assessed radiologically by HRCT of the chest using the scoring method by Bhalla et al.

Exclusion Criteria:

  • cystic fibrosis
  • emphysema on HRCT chest and FEV1<60% predicted
  • active allergic bronchopulmonary aspergillosis or tuberculosis
  • poorly controlled asthma
  • pregnancy or breast feeding
  • current smokers
  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: NCT00868075

Locations
United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH164SA
Sponsors and Collaborators
NHS Lothian
Investigators
Principal Investigator: Adam T Hill, MD, FRCPE NHS Lothian
  More Information

No publications provided by NHS Lothian

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Adam Hill, Consultant Physician and Honorary Senior Lecturer, NHS Lothian
ClinicalTrials.gov Identifier: NCT00868075     History of Changes
Other Study ID Numbers: 08/S1102/40
Study First Received: February 19, 2009
Last Updated: November 4, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by NHS Lothian:
Physiotherapy
Rehabilitation
Bronchiectasis

Additional relevant MeSH terms:
Bronchiectasis
Fibrosis
Bronchial Diseases
Respiratory Tract Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014