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Assessment of Heart & Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation - Article


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Emphysema

Pulmonary Emphysema 




Clinical Trial: Assessment of Heart & Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation

This study is currently recruiting patients.
Verified by Royal Brompton Hospital NHS Trust August 2005

Sponsors and Collaborators: Royal Brompton Hospital NHS Trust
Clinical Research Committee (Royal Brompton)
Information provided by: Royal Brompton Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT00129350

Purpose

At present a specific community based rehabilitation programme for lung or heart-lung transplant recipients does not exist. 160 hospitals throughout the UK offer pulmonary rehabilitation programmes. The programmes operate under evidence-based guidelines as outlined by the Chartered Society of Physiotherapy. Increasing evidence shows that rehabilitation programmes help improve performance, exercise endurance, quality of life, reduce symptoms and demand on health-care resources. This study proposes to compare outcomes of lung and heart-lung transplant patients attending local pulmonary rehabilitation against others receiving the Trust''''s current document-based programme.The study is a randomized controlled trial:

  • Control arm: Those patients randomized to the ''''control'''' arm will receive the Trusts standard rehabilitation programme that consists of an information pack supplied upon discharge. They will then complete and undertake the following tests: Short-Form 36 (SF 36) version 2 Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental Shuttle Walk Test and Spyrometry FEV1 and FVC. The patient will follow the information contained in the information pack and the above tests and questionnaires will be repeated 6 months post discharge.
  • Experimental Arm: A patient who is randomized to the ''''experimental'''' arm will be asked to complete the following tests upon discharge: Short-Form 36 (SF 36) version 2 Questionnaire, Chronic Respiratory Questionnaire (CRQ-SR), Incremental Shuttle Walk Test and Spyrometry FEV1 and FVC. 3 months post discharge, the patient will be enrolled into a local pulmonary rehabilitation programme. The programme is typically structured to last 6-12 weeks. The above tests and questionnaires will be repeated 6 months post discharge.

To measure the effectiveness of either the information pack or the rehabilitation programme the following end points will be subjected to analysis in both the experimental and the control group: Short-Form 36 Questionnaire, Chronic Respiratory Questionnaire, Incremental Shuttle Walk Test, Borg Scale, Spyrometry FEV1 and FVC, Hospital re-admission rates and mortality rates.

The undertaking of a multidisciplinary-led programme of rehabilitation facilitates a better Quality of Life than a document-based rehabilitation programme in lung and or heart-lung transplant out-patients.

The aim of the study is to construct an optimal programme of rehabilitation in lung or heart-lung patients.

Condition Intervention Phase
Emphysema
Fibrosing Alveolitis
Cystic Fibrosis
End Stage Fibrotic Lung Disease
Bronchiectasis
 Procedure: Pulmonary rehabilitation programme
Phase I

MedlinePlus related topics:  Cystic Fibrosis;   Emphysema;   Pulmonary Fibrosis;   Respiratory Diseases
Genetics Home Reference related topics:  cystic fibrosis

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Official Title: An Assessment of Patient Outcomes Following a Rehabilitation Programme for Patients Who Have Received Lung or Heart-Lung Transplant - a Randomised Controlled Trial.

Further Study Details: 
Primary Outcomes: Exercise Shuttle Test (Metres completed)
Secondary Outcomes: Borg Score; Quality of life: SF-36 & Chronic Respiratory Questionnaires; Spirometry; Hospital readmission rates; Organ rejection
Expected Total Enrollment:  60

Study start: September 2004;  Expected completion: October 2008
Last follow-up: February 2008;  Data entry closure: February 2008

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

  • All patients who have undergone either a lung or heart-lung transplant.
  • Who are fit for discharge from the Transplant Unit''''s Intensive Care Unit.
  • > 18 years of age.

Exclusion Criteria:

  • Patients under 18 years of age.
  • Patients unable to understand or comprehend the study.

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00129350

MICHAEL G PREEDY, BSc Econ      02073528121  Ext. 2172    M.Preedy@rbh.nthames.nhs.uk
CHRISTOPHER THEAKER      02073528121  Ext. 8464    C.Theaker@rbh.nthames.nhs.uk

United Kingdom
      Harefield Hospital, Harefield,  UB96JH,  United Kingdom; Recruiting
MICHAEL G PREEDY, BScEcon,  Principal Investigator

Study chairs or principal investigators

MARTIN CARBY,  Principal Investigator,  ROYAL BROMPTON & HAREFIELD NHS TRUST   

More Information

Study ID Numbers:  04-069; 2004NU005B
Last Updated:  August 10, 2005
Record first received:  August 10, 2005
ClinicalTrials.gov Identifier:  NCT00129350
Health Authority: United Kingdom: National Health Service
ClinicalTrials.gov processed this record on 2005-08-23

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Page Updated: December 9, 2005
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