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
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.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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