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Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation

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ClinicalTrials.gov Identifier: NCT00129350
Recruitment Status : Unknown
Verified August 2005 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : August 11, 2005
Last Update Posted : September 7, 2005
Information provided by:

Study Description
Brief Summary:

At present, a specific community based rehabilitation programme for lung or heart-lung transplant recipients does not exist. 160 hospitals throughout the United Kingdom (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, and quality of life; and reduce symptoms and demand on health-care resources. This study proposes to compare the 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 Trust's 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 Spirometry forced expiratory volume in 1 second (FEV1) and forced vital capacity (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 Spirometry FEV1 and FVC. Three 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 endpoints 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;
  • Spirometry 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 or disease Intervention/treatment Phase
Emphysema Alveolitis, Fibrosing Cystic Fibrosis Bronchiectasis Lung Diseases Procedure: Pulmonary rehabilitation programme Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : September 2004
Estimated Study Completion Date : February 2008

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Exercise Shuttle Test (metres completed)

Secondary Outcome Measures :
  1. Borg score
  2. Quality of life: SF-36 and Chronic Respiratory Questionnaires
  3. Spirometry
  4. Hospital re-admission rates
  5. Organ rejection

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • All patients who have undergone either a lung or heart-lung transplant.
  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00129350

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

United Kingdom
Harefield Hospital Recruiting
Harefield, United Kingdom, UB96JH
Principal Investigator: MICHAEL G PREEDY, BScEcon         
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
Principal Investigator: MARTIN CARBY Royal Brompton & Harefield NHS Foundation Trust
More Information

ClinicalTrials.gov Identifier: NCT00129350     History of Changes
Other Study ID Numbers: 04-069
First Posted: August 11, 2005    Key Record Dates
Last Update Posted: September 7, 2005
Last Verified: August 2005

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
End Stage Fibrotic Lung Disease

Additional relevant MeSH terms:
Cystic Fibrosis
Lung Diseases
Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Bronchial Diseases
Lung Diseases, Interstitial