Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Mar 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 19, 2009
CompletedStudy Start
First participant enrolled
March 1, 2009
CompletedFirst Posted
Study publicly available on registry
March 24, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 8, 2011
November 1, 2011
2.4 years
February 19, 2009
November 4, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The primary endpoint of this study is improvement in exercise tolerance from an incremental walk test.
8 weeks
Secondary Outcomes (1)
These include pulmonary physiology, 24 hour sputum volume, sputum appearance, health related quality of life and systemic inflammation.
8 weeks
Study Arms (2)
Chest Physiotherapy
EXPERIMENTALTwice daily chest physiotherapy
Chest Physiotherapy + Exercise Program
EXPERIMENTALChest Physiotherapy + Exercise Program
Interventions
Twice daily chest physiotherapy and Three times weekly exercise program (two sessions supervised)for 8 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NHS Lothianlead
Study Sites (1)
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH164SA, United Kingdom
Related Publications (1)
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.
PMID: 22947443DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam T Hill, MD, FRCPE
NHS Lothian
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Physician and Honorary Senior Lecturer
Study Record Dates
First Submitted
February 19, 2009
First Posted
March 24, 2009
Study Start
March 1, 2009
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 8, 2011
Record last verified: 2011-11