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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by Royal Brompton & Harefield NHS Foundation Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT00129350
First received: August 10, 2005
Last updated: September 6, 2005
Last verified: August 2005

August 10, 2005
September 6, 2005
September 2004
Not Provided
Exercise Shuttle Test (metres completed)
Same as current
Complete list of historical versions of study NCT00129350 on ClinicalTrials.gov Archive Site
  • Borg score
  • Quality of life: SF-36 and Chronic Respiratory Questionnaires
  • Spirometry
  • Hospital re-admission rates
  • Organ rejection
  • Borg Score
  • Quality of life: SF-36 & Chronic Respiratory Questionnaires
  • Spirometry
  • Hospital readmission rates
  • Organ rejection
Not Provided
Not Provided
 
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
An Assessment of Patient Outcomes Following a Rehabilitation Programme for Patients Who Have Received Lung or Heart-Lung Transplant - a Randomised Controlled Trial

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Emphysema
  • Alveolitis, Fibrosing
  • Cystic Fibrosis
  • Bronchiectasis
  • Lung Diseases
Procedure: Pulmonary rehabilitation programme
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
February 2008
Not Provided

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.
Both
18 Years and older
No
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
 
NCT00129350
04-069, 2004NU005B
Not Provided
Not Provided
Royal Brompton & Harefield NHS Foundation Trust
Not Provided
Principal Investigator: MARTIN CARBY Royal Brompton & Harefield NHS Foundation Trust
Royal Brompton & Harefield NHS Foundation Trust
August 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP