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Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Chest physiotherapy
Chest Physiotherapy + Exercise Program
Sponsored by
NHS Lothian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Physiotherapy, Rehabilitation, Bronchiectasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Royal Infirmary of Edinburgh

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Chest Physiotherapy

Chest Physiotherapy + Exercise Program

Arm Description

Twice daily chest physiotherapy

Chest Physiotherapy + Exercise Program

Outcomes

Primary Outcome Measures

The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.

Secondary Outcome Measures

These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.

Full Information

First Posted
February 19, 2009
Last Updated
November 4, 2011
Sponsor
NHS Lothian
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1. Study Identification

Unique Protocol Identification Number
NCT00868075
Brief Title
Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
Official Title
Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2011
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Lothian

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Physiotherapy, Rehabilitation, Bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chest Physiotherapy
Arm Type
Experimental
Arm Description
Twice daily chest physiotherapy
Arm Title
Chest Physiotherapy + Exercise Program
Arm Type
Experimental
Arm Description
Chest Physiotherapy + Exercise Program
Intervention Type
Procedure
Intervention Name(s)
Chest physiotherapy
Intervention Description
Twice daily for 8 weeks
Intervention Type
Procedure
Intervention Name(s)
Chest Physiotherapy + Exercise Program
Intervention Description
Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks
Primary Outcome Measure Information:
Title
The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam T Hill, MD, FRCPE
Organizational Affiliation
NHS Lothian
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH164SA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
22947443
Citation
Mandal P, Sidhu MK, Kope L, Pollock W, Stevenson LM, Pentland JL, Turnbull K, Mac Quarrie S, Hill AT. A pilot study of pulmonary rehabilitation and chest physiotherapy versus chest physiotherapy alone in bronchiectasis. Respir Med. 2012 Dec;106(12):1647-54. doi: 10.1016/j.rmed.2012.08.004. Epub 2012 Sep 1.
Results Reference
derived

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Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis

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