RehabilitationNCT04914624
Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer
A study testing ACBT training, acpella®PEP and EDP-type II external diaphragm pacemaker in people with Rehabilitation, run by Sun Yat-sen University at 1 site in China.
Trial summary
This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, in order to explore the effects of different physical therapy programs on pulmonary rehabilitation in patients with lung cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rehabilitation
- What is being tested?
- ACBT training, acpella®PEP and EDP-type II external diaphragm pacemaker
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Dec 2021
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are diagnosed with non-small cell lung cancer with clear pathological cytology by fiberoptic bronchoscopy and CT, and plan to undergo lobectomy or segmentectomy under general anesthesia for tracheal intubation;
- Age 18-80 years old;
- Those who have stable vital signs and can participate in this research;
- Pulmonary function test FEV1/FVC>0.8.
- Volunteer to participate in this research and sign an informed consent form.
Who cannot join
- Pneumonectomy patients;
- Wedge resection patients
- Patients with distant metastasis of cancer;
- Patients with other malignant tumors;
- Severe complications occurred during the operation, and respiratory function training and testing are not allowed before and after Evaluator;
- Patients with severe physical or mental illness who cannot cooperate with the test;
- Patients with pacemakers, active tuberculosis, and pneumothorax.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat sen University cancer center
Guangzhou, Guangdong
Jiudi Zhong, Bachelor, +86 13610181300, zhongjd@sysucc.org.cn
Qinglin Wang, Bachelor, +86 13826293429, wangql@sysucc.org.cn
About this study
This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, in order to explore the effects of different physical therapy programs on pulmonary rehabilitation in patients with lung cancer. As well as we hope that these physical training programs can effectively improve the lung function of patients, reduce postoperative pulmonary complications, hospitalization days, hospitalization expenses, etc.
Read the detailed description
This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, ninety patients may be enrolled in this study.
Some metrics are used to evaluate the pulmonary rehabilitation status in postoperative patients which include pulmonary function test, 6-Min Walking Test，Borg index, complications incidence, chest tube draining time, and diaphragm muscle mobility.
- Conditions
- Rehabilitation
- Being tested
- ACBT training, acpella®PEP, EDP-type II external diaphragm pacemaker
- Keywords
- pulmonary rehabilitation, external diaphragm pacemaker, expiratory pressure therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACBT trainingBehavioural
Performed 5 days before surgery and one month after surgery, twice a day.
acpella®PEPDevice
Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.
EDP-type II external diaphragm pacemakerDevice
Use external diaphragm pacemaker to stimulate patients' diaphragms.
| Study group | Role | What they receive |
|---|---|---|
| Regular ACBT training | Placebo comparator | Including quitting smoking, ACBT training, cough practicing. Receives: Behavioral: ACBT training |
| Positive expiratory pressure therapy | Experimental | Use acpella®PEP therapeutic system and regular nursing care. Receives: Device: acpella®PEP |
| External diaphragm pacemaker | Experimental | Patients are trained to use external diaphragm pacemaker and receive regular nursing care. Receives: Device: EDP-type II external diaphragm pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline Forced Expiratory Volume In One Second at one month after surgery
Evaluate the change of Forced Expiratory Volume In One Second before the surgery and one month after surgery by conducting Pulmonary Function Test on resectable NSCLC patients
Measured: baseline (before the surgery), and one month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start1 May 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
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 RehabilitationStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914624
- Sponsor's protocol ID
- 2020-ZJD-001
- Status last verified
- May 2021
- First submitted
- 30 Dec 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen X, Li C, Zeng L, Rong T, Lin P, Wang Q, Guo Z, Long H, Zhong J. Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer: a randomised controlled trial. BMC Cancer. 2023 Mar 28;23(1):282. doi: 10.1186/s12885-023-10750-4.
PubMed 36978035
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer
- ClinicalTrials.gov ID
- NCT04914624
- Acronym / sponsor ID
- 2020-ZJD-001
- Conditions
- Rehabilitation
- Keywords
- pulmonary rehabilitation, external diaphragm pacemaker, expiratory pressure therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Jun 2021 (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.
This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, in order to explore the effects of different physical therapy programs on pulmonary rehabilitation in patients with lung cancer. As well as we hope that these physical training programs can effectively improve the lung function of patients, reduce postoperative pulmonary complications, hospitalization days, hospitalization expenses, etc.
Detailed description
This study applies external diaphragm pacemaker and positive expiratory pressure therapy to patients who received thoracic surgeries, ninety patients may be enrolled in this study.
Some metrics are used to evaluate the pulmonary rehabilitation status in postoperative patients which include pulmonary function test, 6-Min Walking Test，Borg index, complications incidence, chest tube draining time, and diaphragm muscle mobility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regular ACBT training | Placebo comparator | Behavioral: ACBT trainingIncluding quitting smoking, ACBT training, cough practicing. |
| Positive expiratory pressure therapy | Experimental | Device: acpella®PEPUse acpella®PEP therapeutic system and regular nursing care. |
| External diaphragm pacemaker | Experimental | Device: EDP-type II external diaphragm pacemakerPatients are trained to use external diaphragm pacemaker and receive regular nursing care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who are diagnosed with non-small cell lung cancer with clear pathological cytology by fiberoptic bronchoscopy and CT, and plan to undergo lobectomy or segmentectomy under general anesthesia for tracheal intubation;
- Age 18-80 years old;
- Those who have stable vital signs and can participate in this research;
- Pulmonary function test FEV1/FVC>0.8.
- Volunteer to participate in this research and sign an informed consent form.
Key exclusion criteria (7 listed)
- Pneumonectomy patients;
- Wedge resection patients
- Patients with distant metastasis of cancer;
- Patients with other malignant tumors;
- Severe complications occurred during the operation, and respiratory function training and testing are not allowed before and after Evaluator;
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 |
|---|---|---|
| ACBT trainingPerformed 5 days before surgery and one month after surgery, twice a day. | Behavioural | Regular ACBT training |
| acpella®PEPContinuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day. | Device | Positive expiratory pressure therapy |
| EDP-type II external diaphragm pacemakerUse external diaphragm pacemaker to stimulate patients' diaphragms. | Device | External diaphragm pacemaker |
Primary outcome
The change from baseline Forced Expiratory Volume In One Second at one month after surgery
Time frame: baseline (before the surgery), and one month after surgery
Evaluate the change of Forced Expiratory Volume In One Second before the surgery and one month after surgery by conducting Pulmonary Function Test on resectable NSCLC patients
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Derived from this study: PubMed 36978035Chen X, Li C, Zeng L, Rong T, Lin P, Wang Q, Guo Z, Long H, Zhong J. Comparative efficacy of different combinations of acapella, active cycle of breathing technique, and external diaphragmatic pacing in perioperative patients with lung cancer: a randomised controlled trial. BMC Cancer. 2023 Mar 28;23(1):282. doi: 10.1186/s12885-023-10750-4.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACBT training, acpella®PEP and EDP-type II external diaphragm pacemaker in people with Rehabilitation, run by Sun Yat-sen University at 1 site in China.
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 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: status not confirmed, as of the sponsor's last update on 4 Jun 2021. 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 China. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiudi Zhong, Bachelor (+86 87343317, zhongjd@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline Forced Expiratory Volume In One Second at one month after surgery (time frame: baseline (before the surgery), and one month after surgery). 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 NCT04914624, 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 4 Jun 2021.