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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
Est. primary completion date
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


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
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