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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00129350
• Other study ID #: 04-069
• Secondary ID: 2004NU005B
• Status: Recruiting
• Phase: Phase 1
• First received: August 10, 2005
• Last updated: September 6, 2005
• Start date: September 2004
• Est. completion date: February 2008

Study information

• Verified date: August 2005
• Source: Royal Brompton & Harefield NHS Foundation Trust
• Contact: MICHAEL G PREEDY, BSc Econ
• Phone: 02073528121
• Email: M.Preedy[@]rbh.nthames.nhs.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alveolitis, Fibrosing
• Bronchiectasis
• Cystic Fibrosis
• Emphysema
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Lung Diseases
• Pulmonary Fibrosis

Intervention

Procedure:
• Pulmonary rehabilitation programme

Locations

Country	Name	City	State
United Kingdom	Harefield Hospital	Harefield

Sponsors (1)

Lead Sponsor	Collaborator
Royal Brompton & Harefield NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise Shuttle Test (metres completed)
Secondary	Borg score
Secondary	Quality of life: SF-36 and Chronic Respiratory Questionnaires
Secondary	Spirometry
Secondary	Hospital re-admission rates
Secondary	Organ rejection