Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer

NCT ID: NCT04914624

Last Updated: 2021-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2021-12-30

Brief Summary

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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

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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

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Rehabilitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Regular ACBT training

Including quitting smoking, ACBT training, cough practicing.

Group Type PLACEBO_COMPARATOR

ACBT training

Intervention Type BEHAVIORAL

Performed 5 days before surgery and one month after surgery, twice a day.

Positive expiratory pressure therapy

Use acpella®PEP therapeutic system and regular nursing care.

Group Type EXPERIMENTAL

acpella®PEP

Intervention Type DEVICE

Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.

External diaphragm pacemaker

Patients are trained to use external diaphragm pacemaker and receive regular nursing care.

Group Type EXPERIMENTAL

EDP-type II external diaphragm pacemaker

Intervention Type DEVICE

Use external diaphragm pacemaker to stimulate patients' diaphragms.

Interventions

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ACBT training

Performed 5 days before surgery and one month after surgery, twice a day.

Intervention Type BEHAVIORAL

acpella®PEP

Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.

Intervention Type DEVICE

EDP-type II external diaphragm pacemaker

Use external diaphragm pacemaker to stimulate patients' diaphragms.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. 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;
2. Age 18-80 years old;
3. Those who have stable vital signs and can participate in this research;
4. Pulmonary function test FEV1/FVC\>0.8.
5. Volunteer to participate in this research and sign an informed consent form.

Exclusion Criteria

1. Pneumonectomy patients;
2. Wedge resection patients
3. Patients with distant metastasis of cancer;
4. Patients with other malignant tumors;
5. Severe complications occurred during the operation, and respiratory function training and testing are not allowed before and after Evaluator;
6. Patients with severe physical or mental illness who cannot cooperate with the test;
7. Patients with pacemakers, active tuberculosis, and pneumothorax.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Hao Long

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sun Yat sen University cancer center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiudi Zhong, Bachelor

Role: CONTACT

+86 87343317

Hao Long, MD

Role: CONTACT

+86 87343261

Facility Contacts

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Jiudi Zhong, Bachelor

Role: primary

+86 13610181300

Qinglin Wang, Bachelor

Role: backup

+86 13826293429

References

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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.

Reference Type DERIVED
PMID: 36978035 (View on PubMed)

Other Identifiers

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2020-ZJD-001

Identifier Type: -

Identifier Source: org_study_id

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