Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00129350
Status:
UNKNOWN
Last Update Posted:
2005-09-07
First Post:
2005-08-10
Brief Title:
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Trusts current document-based programme The study is a randomized controlled trial
Control Arm Those patients randomized to the control arm will receive the Trusts 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
Control Arm Those patients randomized to the control arm will receive the Trusts 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004NU005B | None | None | None |