EmphysemaPhase 1NCT00129350
Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation
A Phase 1 study testing Pulmonary rehabilitation programme in people with Emphysema and Alveolitis, Fibrosing, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emphysema, Alveolitis, Fibrosing, Cystic Fibrosis
- What is being tested?
- Pulmonary rehabilitation programme
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2004to Feb 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age.
- Patients unable to understand or comprehend the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Harefield Hospital
Harefield, UB96JH
MICHAEL G PREEDY, BScEcon
About this study
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.
Read more
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.
- Conditions
- Emphysema, Alveolitis, Fibrosing, Cystic Fibrosis, Bronchiectasis, Lung Diseases
- Being tested
- Pulmonary rehabilitation programme
- Keywords
- End Stage Fibrotic Lung Disease
- Medical subject headings
- Emphysema, Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary rehabilitation programmeProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Shuttle Test (metres completed)
Secondary outcomes (5)
Borg score
Quality of life: SF-36 and Chronic Respiratory Questionnaires
Spirometry
Hospital re-admission rates
Organ rejection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2005 (estimated)
- Study startSep 2004
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EmphysemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Investigators
- MARTIN CARBY, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00129350
- Sponsor's protocol ID
- 04-069
- Other IDs
- 2004NU005B
- Status last verified
- Aug 2005
- First submitted
- 10 Aug 2005
- Last updated
- 7 Sep 2005
- Results posted
- No
Publications
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.
PubMed 34282853
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00129350
- Acronym / sponsor ID
- 04-069
- Conditions
- Emphysema, Alveolitis, Fibrosing, Cystic Fibrosis, Bronchiectasis, Lung Diseases
- Keywords
- End Stage Fibrotic Lung Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2004
- Study completion
- Feb 2008
- First posted
- 11 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients under 18 years of age.
- Patients unable to understand or comprehend the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary rehabilitation programme | Procedure or surgery | – |
Primary outcome
Exercise Shuttle Test (metres completed)
5 secondary outcomes
Borg score
Quality of life: SF-36 and Chronic Respiratory Questionnaires
Spirometry
Hospital re-admission rates
Organ rejection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2005.
- Derived from this study: PubMed 34282853Gutierrez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MARTIN CARBY principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pulmonary rehabilitation programme in people with Emphysema and Alveolitis, Fibrosing, run by Royal Brompton & Harefield NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact MICHAEL G PREEDY, BSc Econ (02073528121 ext. 2172, M.Preedy@rbh.nthames.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise Shuttle Test (metres completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00129350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2005.