Lung NeoplasmNCT06542055
Compare the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength
A study testing Preoperative and postoperative pulmonary rehabilitation exercise and Preoperative education and postoperative exercise in people with Lung Neoplasm, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Lung cancer, tracheal and bronchial cancers have long been the leading cause of cancer mortality in Taiwan. According to statistics, about 40% of newly diagnosed lung cancers are treated with surgery as the primary treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lung Neoplasm
- What is being tested?
- Preoperative and postoperative pulmonary rehabilitation exercise and Preoperative education and postoperative exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTaiwan
- Study dates
- 17 Feb 2023to 30 Jul 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracic surgery with pulmonary resection (including wedge resection, segmentectomy, and lobectomy).
- FEV1≦80%.
- over 20 years old.
- Those who can cooperate with pulmonary rehabilitation and sign the consent form.
Who cannot join
- Suspected metastases to other organs.
- Unsteady gait, limited mobility, unable to cooperate with exercise training
- Those who cannot communicate in Mandarin or Taiwanese.
- Oxygen saturation ≦85% at rest and without oxygen.
- New York Heart Association (NYHA) defines heart failure as grade IV.
- FEV1<30% and ever diagnosed COPD patients.
- S/P pneumonectomy patient.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, Zhongzheng District, 100
About this study
Official title: Comparison of the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength in Lung Neoplasm Resection Patients
Lung cancer, tracheal and bronchial cancers have long been the leading cause of cancer mortality in Taiwan. According to statistics, about 40% of newly diagnosed lung cancers are treated with surgery as the primary treatment. Although early surgery improves survival rates, most patients experience significant decreases in lung function, and physical function after surgery, which affects their quality of life.
Recent studies have found that preoperative and postoperative lung rehabilitation exercises play an increasingly important role in lung cancer care. In Taiwan, postoperative interventions for lung cancer have shown significant benefits, but there is a lack of evidence on the effectiveness of preoperative rehabilitation programs. To understand the effectiveness of the preoperative pulmonary rehabilitation program, a preoperative home rehabilitation program was designed to compare the efficacy of preoperative pulmonary rehabilitation in the current lung cancer care of patients undergoing lung neoplasm surgery.
Read the detailed description
After confirming that the patient is eligible to participate and the patient signs a consent, basic information and The Hospital Anxiety and Depression Scale (HADS) will be completed at the preoperative clinic, and lung function tests, 30-second 30 seconds sit-to-stand test, grip strength test, physical status assessment, and activity level assessment will be performed. A healthcare instruction manual will be given at the preoperative clinic.
The preoperative exercise group (experimental group) and the control group will be assigned randomly. The preoperative exercise experiment group must complete the related exercises and records. The exercises include upper extremity resistance exercise, lower extremity resistance exercise, aerobic exercise, and respiratory muscle training.
- Conditions
- Lung Neoplasm
- Being tested
- Preoperative and postoperative pulmonary rehabilitation exercise, Preoperative education and postoperative exercise
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative and postoperative pulmonary rehabilitation exerciseOther
Besides receiving preoperative thoracic surgery health education manuals and postoperative regular pulmonary rehabilitation exercises, they also receive exercises originally tailored for pulmonary rehabilitation, including upper-body resistance exercise, lower-body resistance exercise, aerobic exercise, and respiratory muscle training for 4-7 days before surgery. In addition, a communication app group will be set up and an exercise diary will be provided.
Preoperative education and postoperative exerciseOther
Receiving preoperative thoracic surgery health education manual and postoperative regular pulmonary rehabilitation exercises
| Study group | Role | What they receive |
|---|---|---|
| Preoperative & postoperative exercise | Experimental | Will receive preoperative thoracic surgery health education manuals. Tailored preoperative pulmonary rehabilitation exercises and postoperative regular pulmonary rehabilitation exercises. Receives: Other: Preoperative and postoperative pulmonary rehabilitation exercise |
| Postoperative exercise | Active comparator | Preoperatively, an education manual was provided; postoperatively, routine rehabilitation exercises were given. Receives: Other: Preoperative education and postoperative exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression
The patient's anxiety was assessed by the Hospital Anxiety and Depression Scale (HADS).
The scale consists of 14 items, with 7 items for anxiety and 7 items for depression. The anxiety items are the odd-numbered questions, and the depression items are the even-numbered questions. Each item is scored on a four-point scale (0-3 points). The scores for the two subscales are calculated separately, each with a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety or depression.
Measured: at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)
Secondary outcomes (5)
Lung function
Lung function will be assessed using MicroLab Spirometer.
- Forced Vital Capacity；FVC (L)、(% predicted)
- Forced Expiratory Volume in First Second；FEV1)(L) 、(% predicted)
- Peak Expiratory Flow Rate；PERF(L/S)、(% predicted)
- FEV1/FVC(%)
Measured: Through preoperative intervention, rehabilitation exercises for the lungs were performed for up to 6 weeks after surgery until discharge. The time frame includes at baseline (preoperative outpatient department)、at admission and before discharge
Early Activity Level
ICCA (IntelliSpace Critical Care and Anesthesia) Ranges from 0-10, the higher level indicates better functional activity.
Measured: Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.The initial activity level after surgery (through study completion, an average of 3 weeks)
Grip strength
measured with TTM-YD digital grip strength dynamometer
Measured: at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)
Lower limb muscle strength
30 seconds sit and stand test
Measured: Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.Time Frame at baseline(preoperative OPD).
Physical condition
ECOG Performance Status Scale 0 Fully active, able to carry on all pre-disease performance without restriction
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
- Dead
Measured: Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.Time Frame at baseline(preoperative OPD)、the next day after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start17 Feb 2023
- Primary completion28 Feb 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung NeoplasmStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542055
- Sponsor's protocol ID
- 202207101RINC
- Status last verified
- Jul 2024
- First submitted
- 13 Feb 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- 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 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Preoperative Pulmonary Rehabilitation Exercises on Postoperative Anxiety and Muscle Strength in Lung Neoplasm Resection Patients
- ClinicalTrials.gov ID
- NCT06542055
- Acronym / sponsor ID
- 202207101RINC
- Conditions
- Lung Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 7 Aug 2024 (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.
Lung cancer, tracheal and bronchial cancers have long been the leading cause of cancer mortality in Taiwan. According to statistics, about 40% of newly diagnosed lung cancers are treated with surgery as the primary treatment. Although early surgery improves survival rates, most patients experience significant decreases in lung function, and physical function after surgery, which affects their quality of life.
Recent studies have found that preoperative and postoperative lung rehabilitation exercises play an increasingly important role in lung cancer care. In Taiwan, postoperative interventions for lung cancer have shown significant benefits, but there is a lack of evidence on the effectiveness of preoperative rehabilitation programs. To understand the effectiveness of the preoperative pulmonary rehabilitation program, a preoperative home rehabilitation program was designed to compare the efficacy of preoperative pulmonary rehabilitation in the current lung cancer care of patients undergoing lung neoplasm surgery.
Detailed description
After confirming that the patient is eligible to participate and the patient signs a consent, basic information and The Hospital Anxiety and Depression Scale (HADS) will be completed at the preoperative clinic, and lung function tests, 30-second 30 seconds sit-to-stand test, grip strength test, physical status assessment, and activity level assessment will be performed. A healthcare instruction manual will be given at the preoperative clinic.
The preoperative exercise group (experimental group) and the control group will be assigned randomly. The preoperative exercise experiment group must complete the related exercises and records. The exercises include upper extremity resistance exercise, lower extremity resistance exercise, aerobic exercise, and respiratory muscle training.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative & postoperative exercise | Experimental | Other: Preoperative and postoperative pulmonary rehabilitation exerciseWill receive preoperative thoracic surgery health education manuals. Tailored preoperative pulmonary rehabilitation exercises and postoperative regular pulmonary rehabilitation exercises. |
| Postoperative exercise | Active comparator | Other: Preoperative education and postoperative exercisePreoperatively, an education manual was provided; postoperatively, routine rehabilitation exercises were given. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing thoracic surgery with pulmonary resection (including wedge resection, segmentectomy, and lobectomy).
- FEV1≦80%.
- over 20 years old.
- Those who can cooperate with pulmonary rehabilitation and sign the consent form.
Key exclusion criteria (7 listed)
- Suspected metastases to other organs.
- Unsteady gait, limited mobility, unable to cooperate with exercise training
- Those who cannot communicate in Mandarin or Taiwanese.
- Oxygen saturation ≦85% at rest and without oxygen.
- New York Heart Association (NYHA) defines heart failure as grade IV.
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 |
|---|---|---|
| Preoperative and postoperative pulmonary rehabilitation exerciseBesides receiving preoperative thoracic surgery health education manuals and postoperative regular pulmonary rehabilitation exercises, they also receive exercises originally tailored for pulmonary rehabilitation, including upper-body resistance exercise, lower-body resistance exercise, aerobic exercise, and respiratory muscle training for 4-7 days before surgery. In addition, a communication app group will be set up and an exercise diary will be provided. | Other | Preoperative & postoperative exercise |
| Preoperative education and postoperative exerciseReceiving preoperative thoracic surgery health education manual and postoperative regular pulmonary rehabilitation exercises | Other | Postoperative exercise |
Primary outcome
Anxiety and depression
Time frame: at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)
The patient's anxiety was assessed by the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items, with 7 items for anxiety and 7 items for depression. The anxiety items are the odd-numbered questions, and the depression items are the even-numbered questions. Each item is scored on a four-point scale (0-3 points). The scores for the two subscales are calculated separately, each with a total score ranging from 0 to 21. Higher scores indicate greater levels of anxiety or depression.
5 secondary outcomes
Lung function
Time frame: Through preoperative intervention, rehabilitation exercises for the lungs were performed for up to 6 weeks after surgery until discharge. The time frame includes at baseline (preoperative outpatient department)、at admission and before discharge
Early Activity Level
Time frame: Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.The initial activity level after surgery (through study completion, an average of 3 weeks)
Grip strength
Time frame: at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)
Lower limb muscle strength
Time frame: Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.Time Frame at baseline(preoperative OPD).
Physical condition
Time frame: Through preoperative intervention, rehabilitation exercises for the lungs were performed until about a month after surgery before discharge.Time Frame at baseline(preoperative OPD)、the next day after 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 7 Aug 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 Preoperative and postoperative pulmonary rehabilitation exercise and Preoperative education and postoperative exercise in people with Lung Neoplasm, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 7 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 7 Aug 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 Taiwan. 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?
Anxiety and depression (time frame: at preoperative OPD(baseline), admission, and discharge (through study completion, an average of 3 weeks)). 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 7 Aug 2024.