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

Primary Purpose

Emphysema, Alveolitis, Fibrosing, Cystic Fibrosis

Status
Unknown status
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
Pulmonary rehabilitation programme
Sponsored by
Royal Brompton & Harefield NHS Foundation Trust
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Emphysema focused on measuring End Stage Fibrotic Lung Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Harefield HospitalRecruiting

Outcomes

Primary Outcome Measures

Exercise Shuttle Test (metres completed)

Secondary Outcome Measures

Borg score
Quality of life: SF-36 and Chronic Respiratory Questionnaires
Spirometry
Hospital re-admission rates
Organ rejection

Full Information

First Posted
August 10, 2005
Last Updated
September 6, 2005
Sponsor
Royal Brompton & Harefield NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT00129350
Brief Title
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

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2008 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Royal Brompton & Harefield NHS Foundation Trust

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema, Alveolitis, Fibrosing, Cystic Fibrosis, Bronchiectasis, Lung Diseases
Keywords
End Stage Fibrotic Lung Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Pulmonary rehabilitation programme
Primary Outcome Measure Information:
Title
Exercise Shuttle Test (metres completed)
Secondary Outcome Measure Information:
Title
Borg score
Title
Quality of life: SF-36 and Chronic Respiratory Questionnaires
Title
Spirometry
Title
Hospital re-admission rates
Title
Organ rejection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MICHAEL G PREEDY, BSc Econ
Phone
02073528121
Ext
2172
Email
M.Preedy@rbh.nthames.nhs.uk
First Name & Middle Initial & Last Name or Official Title & Degree
CHRISTOPHER THEAKER
Phone
02073528121
Ext
8464
Email
C.Theaker@rbh.nthames.nhs.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARTIN CARBY
Organizational Affiliation
Royal Brompton & Harefield NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harefield Hospital
City
Harefield
ZIP/Postal Code
UB96JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MICHAEL G PREEDY, BScEcon

12. IPD Sharing Statement

Citations:
PubMed Identifier
34282853
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.
Results Reference
derived

Learn more about this trial

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

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