Lung CancerNCT01963923
Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Patients Awaiting Lung Resection
A study testing Pulmonary Rehabilitation Program in people with Lung Cancer, run by Universidade da Coruña at 1 site in Spain.
Trial summary
The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Pulmonary Rehabilitation Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2013to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Diagnosis confirmed or suspected of lung cancer (either primary or metastatic)
- Be on the waiting list for lung resection by Video-assisted thoracic surgery
- Present at least one of the next conditions: Forced Expiratory Volume in 1 second (FEV1)<80% of predicted and/or Body Mass Index > 30 or/and >80 years old and/or two or more comorbidities (Arterial Hypertension, Chronic Obstructive Pulmonary Disease, Coronary Disease, Diabetes, Renal Failure and/or cancer.
- No smoking at the time of recruitment
- Signed Informed Consent
Who cannot join
- Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
- Thoracotomies or pneumonectomies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Exercise Tolerance and Quality of Life in Patients Awaiting Lung Resection by Video-assisted Thoracic Surgery
The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.
- Conditions
- Lung Cancer
- Being tested
- Pulmonary Rehabilitation Program
- Keywords
- Pulmonary Rehabilitation, Lung Cancer Resection, Video-assisted thoracic surgery, Exercise tolerance, Quality of life
- 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 Rehabilitation ProgramBehavioural
Also called Endurance training, Strenght training, Incentive Spirometry
The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
| Study group | Role | What they receive |
|---|---|---|
| Rehabilitation Group | Experimental | The rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program Receives: Behavioral: Pulmonary Rehabilitation Program |
| Control Group | No intervention | The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise Tolerance
Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three weeks after hospital discharge in comparison with the control group.
Measured: Exercise tolerance 3 weeks after hospital discharge
Exercise Tolerance
Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three months after hospital discharge in comparison with the control group.
Measured: Exercise tolerance 3 months after surgery
Secondary outcomes (6)
Health-Related Quality of Life
Health-Related Quality of Life measured with the 36-Item Short-Form Health Survey Version 2 (SF-36) three weeks post-surgery. This scale is scored on a 0 - 100 scale, with higher scores referring to a better health-related quality of life. The scale compromises 8 subscales and two summaries (physial and mental).
Measured: Quality of life 3 weeks after surgery
Health-Related Quality of Life
Health-Related Quality of Life measured with the 36-Item Short-Form Health Survey Version 2 (SF-36) three months post-surgery. This scale is scored on a 0 - 100 scale, with higher scores referring to a better health-related quality of life. The scale compromises 8 subscales and two summaries (physial and mental).
Measured: Quality of life post-surgery
Upper Body Strength
Upper body strength measured with the Arm-Curl Test of the Senior Fitness Test. The test measures the number of curl-arm movements with a 2.27kg or a 3.61 kg dumbbell for women and men respectively during 30 seconds.
Measured: 3 weeks post-surgery
Upper Body Strength
Upper body strength measured with the Arm-Curl Test of the Senior Fitness Test. The test measures the number of curl-arm movements with a 2.27kg or a 3.61 kg dumbbell for women and men respectively during 30 seconds.
Measured: 3 months post-surgery
Lower Body Strength
Lower body strength measured with the sit-to-stand Test. The test consist of counting the number of full stands from a chair that can be completed in 30 seconds with arms folded across chest.
Measured: 3 weeks post-surgery
Lower Body Strength
Lower body strength measured with the sit-to-stand Test. The test consist of counting the number of full stands from a chair that can be completed in 30 seconds with arms folded across chest.
Measured: 3 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esther Gimenez Moolhuyzen, Hospital Juan Canalejo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963923
- Sponsor's protocol ID
- RCP-RSG-2011
- Status last verified
- Apr 2020
- First submitted
- 10 Oct 2013
- Last updated
- 1 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Sebio Garcia R, Yanez-Brage MI, Gimenez Moolhuyzen E, Salorio Riobo M, Lista Paz A, Borro Mate JM. Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial. Clin Rehabil. 2017 Aug;31(8):1057-1067. doi: 10.1177/0269215516684179. Epub 2016 Dec 20.
PubMed 28730888
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Preoperative Pulmonary Rehabilitation Program in Exercise Tolerance and Quality of Life in Patients Awaiting Lung Resection by Video-assisted Thoracic Surgery
- ClinicalTrials.gov ID
- NCT01963923
- Acronym / sponsor ID
- RCP-RSG-2011
- Conditions
- Lung Cancer
- Keywords
- Pulmonary Rehabilitation, Lung Cancer Resection, Video-assisted thoracic surgery, Exercise tolerance, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Posted 1 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the effectiveness of a preoperative pulmonary rehabilitation program in patients awaiting lung resection for lung cancer by Video-assisted thoracic surgery in order to improve exercise tolerance and quality of life. The investigators hypothesized that a pulmonary rehabilitation program including both endurance and strength training may improve exercise tolerance and quality of life measured with a submaximal exercise test and a quality of life questionnaire respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation Group | Experimental | Behavioral: Pulmonary Rehabilitation ProgramThe rehabilitation group must complete at least 16 sessions of the Pulmonary Rehabilitation Program |
| Control Group | No intervention | –The control group must complete only the outcome measures and continue with their clinical routine as specified by their physicians. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis confirmed or suspected of lung cancer (either primary or metastatic)
- Be on the waiting list for lung resection by Video-assisted thoracic surgery
- Present at least one of the next conditions: Forced Expiratory Volume in 1 second (FEV1)<80% of predicted and/or Body Mass Index > 30 or/and >80 years old and/or two or more comorbidities (Arterial Hypertension, Chronic Obstructive Pulmonary Disease, Coronary Disease, Diabetes, Renal Failure and/or cancer.
- No smoking at the time of recruitment
- Signed Informed Consent
Key exclusion criteria (2 listed)
- Chemotherapy or Radiotherapy in the previous 6 months before the Rehabilitation program.
- Thoracotomies or pneumonectomies.
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 ProgramAlso: Endurance training, Strenght training, Incentive SpirometryThe pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device. | Behavioural | Rehabilitation Group |
Primary outcome
Exercise Tolerance
Time frame: Exercise tolerance 3 weeks after hospital discharge
Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three weeks after hospital discharge in comparison with the control group.
Exercise Tolerance
Time frame: Exercise tolerance 3 months after surgery
Maximum time sustained (in seconds) during the constant-load cycle endurance test performed at 80% of the maximal workload achieved measured three months after hospital discharge in comparison with the control group.
6 secondary outcomes
Health-Related Quality of Life
Time frame: Quality of life 3 weeks after surgery
Health-Related Quality of Life
Time frame: Quality of life post-surgery
Upper Body Strength
Time frame: 3 weeks post-surgery
Upper Body Strength
Time frame: 3 months post-surgery
Lower Body Strength
Time frame: 3 weeks post-surgery
Lower Body Strength
Time frame: 3 months post-surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28730888Sebio Garcia R, Yanez-Brage MI, Gimenez Moolhuyzen E, Salorio Riobo M, Lista Paz A, Borro Mate JM. Preoperative exercise training prevents functional decline after lung resection surgery: a randomized, single-blind controlled trial. Clin Rehabil. 2017 Aug;31(8):1057-1067. doi: 10.1177/0269215516684179. Epub 2016 Dec 20.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation Program in people with Lung Cancer, run by Universidade da Coruña at 1 site in Spain.
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 5 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: finished, as of the sponsor's last update on 1 May 2020. 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 Spain. 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?
Yes. Results are posted in the registry (first posted 1 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Exercise Tolerance (time frame: Exercise tolerance 3 weeks after hospital discharge). The study lists 2 primary outcomes in all. 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 NCT01963923, 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 1 May 2020.