Lung CancerNCT05891340
Effects of Prehabilitation on Postoperative Recovery
A study testing Respiratory muscle exercise and Endurance exercise in people with Lung Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study. 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?
- Respiratory muscle exercise and Endurance exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 30 Apr 2024
- 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
- ASA physical status classification system score 1-3 patients
- Patients who underwent lung resection
- Patients who agreed to participate in the study and gave written informed consent
Who cannot join
- Re-operation
- Emergency operations
- Patients with psychiatric drug use
- unability for physical exercise
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Prehabilitation on Postoperative Recovery in Patients Undergoing Lung Resection
The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study.
Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Prehabilitation consists of respiratory muscle exercise and walking is recommended to Intervention Group.
Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day and 1st month. The intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.
Read the detailed description
The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study. Patients will be informed about the study and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Routine preoperative evaluation including detailed history (daily physical activity, clinical complaints at rest or exertion, if any) and physical examination will be performed on the patients. Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Preoperative exercise, alcohol and smoking cessation are recommended to all patients. Prehabilitation consists of respiratory muscle exercise with inspiratory muscle trainer (two times a day) and walking (5000steps/day) is recommended to Intervention Group. Hospitalized patients are followed up with daily visits, and patients who are at home are followed up by phone call. All patients' induction of anesthesia and maintenance were similar.
Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day (as primary outcome) and 1st month. The duration of anesthesia, surgery duration, intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.
- Conditions
- Lung Cancer
- Being tested
- Respiratory muscle exercise, Endurance exercise
- Keywords
- prehabilitation, quality of recovery, lung resection
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle exerciseOther
respiratory muscle exercise with inspiratory muscle trainer (two times a day)
Endurance exerciseOther
walking exercise 5000 steps/day
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Preoperative exercise, alcohol and smoking cessation are recommended to patients. |
| Intervention | Active comparator | Respiratory muscle exercise (two times a day) and walking (5000steps/day) are recommended to the patients preoperatively. Receives: Other: Respiratory muscle exercise; Other: Endurance exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of recovery at postoperative second day
The primary aim of our study is to compare recovery of patients who have prehabilitation programme and who have not any programme by using QoR-15 questionnaire on the 2nd postoperative day.
Measured: two days
Secondary outcomes (4)
Quality of recovery at postoperative first month
Investigating recovery of patients by by using QoR-15 questionnaire
Measured: one month
length of intensive care unit stay
Investigating planned or unplanned ICU admission
Measured: two weeks
Length of hospital stay
patients' length of stay
Measured: one month
Postoperative pulmonary complications
Patients' pulmonary complications such as pneumonia, atelectasis, hemorrhage, emphysema, prolonged air leak, chylothorax and respiratory failure.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Jun 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
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.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, prospective
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Turhan, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891340
- Sponsor's protocol ID
- 2022/2131
- Status last verified
- May 2024
- First submitted
- 25 May 2023
- Last updated
- 17 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Prehabilitation on Postoperative Recovery in Patients Undergoing Lung Resection
- ClinicalTrials.gov ID
- NCT05891340
- Acronym / sponsor ID
- 2022/2131
- Conditions
- Lung Cancer
- Keywords
- prehabilitation, quality of recovery, lung resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 Jun 2023 (actual)
- 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.
The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study.
Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Prehabilitation consists of respiratory muscle exercise and walking is recommended to Intervention Group.
Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day and 1st month. The intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.
Detailed description
The study to be carried out in the Istanbul Faculty of Medicine Department of Anesthesiology was planned as a randomized, prospective study. Patients who will undergo lung resection will be included in the study. Patients will be informed about the study and their written consent will be obtained. Patients who do not give consent will not be included in the study.
Routine preoperative evaluation including detailed history (daily physical activity, clinical complaints at rest or exertion, if any) and physical examination will be performed on the patients. Patients were randomized into two groups: Intervention Group includes patients who are rehabilitated preoperatively (prehabilitation), Control Group includes patients who are routinely recommended preoperative exercise, alcohol and smoking cessation. Preoperative exercise, alcohol and smoking cessation are recommended to all patients. Prehabilitation consists of respiratory muscle exercise with inspiratory muscle trainer (two times a day) and walking (5000steps/day) is recommended to Intervention Group. Hospitalized patients are followed up with daily visits, and patients who are at home are followed up by phone call. All patients' induction of anesthesia and maintenance were similar.
Postoperative recovery will be questioned with Quality of Recovery-15 (QoR-15) on the 2nd day (as primary outcome) and 1st month. The duration of anesthesia, surgery duration, intensive care unit admission, postoperative pulmonary complications and length of hospital stay will be recorded.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- randomized, prospective
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Preoperative exercise, alcohol and smoking cessation are recommended to patients. |
| Intervention | Active comparator | Other: Respiratory muscle exercise, Other: Endurance exerciseRespiratory muscle exercise (two times a day) and walking (5000steps/day) are recommended to the patients preoperatively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA physical status classification system score 1-3 patients
- Patients who underwent lung resection
- Patients who agreed to participate in the study and gave written informed consent
Key exclusion criteria (4 listed)
- Re-operation
- Emergency operations
- Patients with psychiatric drug use
- unability for physical exercise
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 |
|---|---|---|
| Respiratory muscle exerciserespiratory muscle exercise with inspiratory muscle trainer (two times a day) | Other | Intervention |
| Endurance exercisewalking exercise 5000 steps/day | Other | Intervention |
Primary outcome
Quality of recovery at postoperative second day
Time frame: two days
The primary aim of our study is to compare recovery of patients who have prehabilitation programme and who have not any programme by using QoR-15 questionnaire on the 2nd postoperative day.
4 secondary outcomes
Quality of recovery at postoperative first month
Time frame: one month
length of intensive care unit stay
Time frame: two weeks
Length of hospital stay
Time frame: one month
Postoperative pulmonary complications
Time frame: one month
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 May 2024.
- Individual participant dataSharing planned: No
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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 Respiratory muscle exercise and Endurance exercise in people with Lung Cancer, run by Istanbul University at 1 site in Turkey (Türkiye).
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 4 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 May 2024. 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 Turkey (Türkiye). 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?
Quality of recovery at postoperative second day (time frame: two days). 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 May 2024.