Clinical trial NCT00129350: Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Emphysema
Alveolitis, Fibrosing
Cystic Fibrosis
Bronchiectasis
Lung Diseases
Keywords: End Stage Fibrotic Lung Disease
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2005-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Exercise Shuttle Test (metres completed)
Secondary outcomes:
measure: Borg score
measure: Quality of life: SF-36 and Chronic Respiratory Questionnaires
measure: Spirometry
measure: Hospital re-admission rates
measure: Organ rejection
Other outcomes:
Locations:
city: Harefield
country: United Kingdom
facility: Harefield Hospital
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: MARTIN CARBY
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutierrez-Arias R, Martinez-Zapata MJ, Gaete-Mahn MC, Osorio D, Bustos L, Melo Tanner J, Hidalgo R, Seron P. Exercise training for adult lung transplant recipients. Cochrane Database Syst Rev. 2021 Jul 20;7(7):CD012307. doi: 10.1002/14651858.CD012307.pub2.