Lung CancerNCT01246297
Effect of Pulmonary Rehabilitation in Lung Cancer Survivors
A study testing Pulmonary Rehabilitation and Usual post operative care in people with Lung Cancer and Lobectomy, run by Imperial College Healthcare NHS Trust at 2 sites in United Kingdom.
Trial summary
Patients who have surgery to cure lung cancer often have multiple problems at hospital discharge and later on. This includes poor exercise performance and quality of life, breathlessness, pain and tiredness. Currently there is little formal physical or psychological support for such patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Lobectomy, Pulmonary Rehabilitation
- What is being tested?
- Pulmonary Rehabilitation and Usual post operative care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2010to Nov 2011
- Phase
- Interventional
- 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 undergoing lung cancer surgery with curative intent.
Who cannot join
- Unstable cardiovascular disease Severe musculo-skeletal problems that would limit exercise training(neuromuscular disorders, severe joint arthritis of lower limbs) Severe peripheral vascular disease Unable to walk 10 metres unaided Patients unable to give informed consent Recent (within 3 months of completing treatment) or untreated pulmonary TB, Untreated/uncontrolled diabetes or epilepsy Recent or recurrent untreated spontaneous pneumothorax
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Harefield Hospital
Harefield, Middlesex, UB9 6JH
Imperial College Healthcare Trust
London, W21NY
About this study
Official title: A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer
Patients who have surgery to cure lung cancer often have multiple problems at hospital discharge and later on. This includes poor exercise performance and quality of life, breathlessness, pain and tiredness. Currently there is little formal physical or psychological support for such patients. This pilot study aims to investigate whether outpatient pulmonary rehabilitation (an exercise training and education programme), started within 2 weeks of hospital discharge, can lead to improvements in exercise performance and quality of life in patients who have undergone lung cancer surgery. The study will also assess whether pulmonary rehabilitation is acceptable for patients and will analyze the safety profile. The hypothesis is that patients; discharged from hospital after undergoing lung cancer surgery, have improved exercise performance and quality of life following early outpatient pulmonary rehabilitation compared with usual care.
Read the detailed description
The research question is to investigate
- whether patients who have undergone curative surgical resection for lung cancer benefit from 8 weeks of early outpatient pulmonary rehabilitation (started within 2 weeks of hospital discharge).
- to identify potential barriers to this approach
Pulmonary rehabilitation (PR) is the most effective non-pharmacological treatment for patients with chronic respiratory diseases, especially COPD. Many patients with lung cancer have co-existing smoking-related lung disorders such as COPD. To date there have been no randomised controlled trials of PR in post-resection lung cancer survivors. However there is indirect evidence that PR may be of benefit in this patient cohort. Cesario et al (2007)reported a 32% improvement in exercise capacity with in-patient PR, and Spruit et al (2009) demonstrated a 43% improvement in six minute walk distance following an 8-week in-patient PR programme. However, both studies had small numbers, and no randomised control group. Furthermore, inpatient PR is not an economically justifiable intervention in the NHS where emphasis is on self-management and ambulatory care.
- Conditions
- Lung Cancer, Lobectomy, Pulmonary Rehabilitation
- Being tested
- Pulmonary Rehabilitation, Usual post operative care
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
Twice weekly exercise classes with an education component. For 8 weeks.
Usual post operative careOther
Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Usual Care Receives: Other: Usual post operative care |
| Pulmonary Rehabilitation | Active comparator | Pulmonary Rehabilitation consists of twice weekly exercise classes with an educational component. Receives: Other: Pulmonary Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Six minute walk test to assess exercise tolerance
Measured: Within 3 month of discharge from surgery
Secondary outcomes (3)
Shoulder Range of Motion Changes
Measured: Within 3 months of discharge from surgery
Bioimpedence for tissue composition
Measured: Within 3 months of discharge from surgery
Quality of life measurement changes
Measured: Within 3 months of discharge from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionJul 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, London Cancer Alliance (North West London Cancer Network)
- Responsible party
- Sponsor
- Investigators
- Sarah Elkin, FRCP, Principal investigator, Imperial College Healthcare Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246297
- Sponsor's protocol ID
- JROSM0090
- Status last verified
- Mar 2022
- First submitted
- 22 Nov 2010
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Early Outpatient Pulmonary Rehabilitation Following Thoracic Surgery for Lung Cancer
- ClinicalTrials.gov ID
- NCT01246297
- Acronym / sponsor ID
- JROSM0090
- Conditions
- Lung Cancer, Lobectomy, Pulmonary Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Royal Brompton & Harefield NHS Foundation Trust, London Cancer Alliance (North West London Cancer Network)
- Study start
- Oct 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 23 Nov 2010 (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.
Patients who have surgery to cure lung cancer often have multiple problems at hospital discharge and later on. This includes poor exercise performance and quality of life, breathlessness, pain and tiredness. Currently there is little formal physical or psychological support for such patients. This pilot study aims to investigate whether outpatient pulmonary rehabilitation (an exercise training and education programme), started within 2 weeks of hospital discharge, can lead to improvements in exercise performance and quality of life in patients who have undergone lung cancer surgery. The study will also assess whether pulmonary rehabilitation is acceptable for patients and will analyze the safety profile. The hypothesis is that patients; discharged from hospital after undergoing lung cancer surgery, have improved exercise performance and quality of life following early outpatient pulmonary rehabilitation compared with usual care.
Detailed description
The research question is to investigate
- whether patients who have undergone curative surgical resection for lung cancer benefit from 8 weeks of early outpatient pulmonary rehabilitation (started within 2 weeks of hospital discharge).
- to identify potential barriers to this approach
Pulmonary rehabilitation (PR) is the most effective non-pharmacological treatment for patients with chronic respiratory diseases, especially COPD. Many patients with lung cancer have co-existing smoking-related lung disorders such as COPD. To date there have been no randomised controlled trials of PR in post-resection lung cancer survivors. However there is indirect evidence that PR may be of benefit in this patient cohort. Cesario et al (2007)reported a 32% improvement in exercise capacity with in-patient PR, and Spruit et al (2009) demonstrated a 43% improvement in six minute walk distance following an 8-week in-patient PR programme. However, both studies had small numbers, and no randomised control group. Furthermore, inpatient PR is not an economically justifiable intervention in the NHS where emphasis is on self-management and ambulatory care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: Usual post operative careUsual Care |
| Pulmonary Rehabilitation | Active comparator | Other: Pulmonary RehabilitationPulmonary Rehabilitation consists of twice weekly exercise classes with an educational component. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing lung cancer surgery with curative intent.
Key exclusion criteria (1 listed)
- Unstable cardiovascular disease Severe musculo-skeletal problems that would limit exercise training(neuromuscular disorders, severe joint arthritis of lower limbs) Severe peripheral vascular disease Unable to walk 10 metres unaided Patients unable to give informed consent Recent (within 3 months of completing treatment) or untreated pulmonary TB, Untreated/uncontrolled diabetes or epilepsy Recent or recurrent untreated spontaneous pneumothorax
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 RehabilitationTwice weekly exercise classes with an education component. For 8 weeks. | Other | Pulmonary Rehabilitation |
| Usual post operative careUsual post operative care for post lung lobectomy patients for 8 weeks post discharge. | Other | Control |
Primary outcome
Six minute walk test to assess exercise tolerance
Time frame: Within 3 month of discharge from surgery
3 secondary outcomes
Shoulder Range of Motion Changes
Time frame: Within 3 months of discharge from surgery
Bioimpedence for tissue composition
Time frame: Within 3 months of discharge from surgery
Quality of life measurement changes
Time frame: Within 3 months of discharge from surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
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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.
Sarah Elkin, FRCP principal investigator
Imperial College Healthcare Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation and Usual post operative care in people with Lung Cancer and Lobectomy, run by Imperial College Healthcare NHS Trust at 2 sites 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Six minute walk test to assess exercise tolerance (time frame: Within 3 month of discharge from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2022.