Effects of Different Physical Therapy Programs on Pulmonary Rehabilitation in Patients With Lung Cancer
3. juni 2021 opdateret af: Hao Long, Sun Yat-sen University
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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Jiudi Zhong, Bachelor
- Telefonnummer: +86 87343317
- E-mail: zhongjd@sysucc.org.cn
Undersøgelse Kontakt Backup
- Navn: Hao Long, MD
- Telefonnummer: +86 87343261
- E-mail: longhao@sysucc.org.cn
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina
- Rekruttering
- Sun Yat Sen University Cancer Center
-
Kontakt:
- Jiudi Zhong, Bachelor
- Telefonnummer: +86 13610181300
- E-mail: zhongjd@sysucc.org.cn
-
Kontakt:
- Qinglin Wang, Bachelor
- Telefonnummer: +86 13826293429
- E-mail: wangql@sysucc.org.cn
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Regular ACBT training
Including quitting smoking, ACBT training, cough practicing.
|
Performed 5 days before surgery and one month after surgery, twice a day.
|
|
Eksperimentel: Positive expiratory pressure therapy
Use acpella®PEP therapeutic system and regular nursing care.
|
Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.
|
|
Eksperimentel: External diaphragm pacemaker
Patients are trained to use external diaphragm pacemaker and receive regular nursing care.
|
Use external diaphragm pacemaker to stimulate patients' diaphragms.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The change from baseline Forced Expiratory Volume In One Second at one month after surgery
Tidsramme: 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
|
baseline (before the surgery), and one month after surgery
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The change from baseline Borg Score at one month after surgery.
Tidsramme: baseline (before the surgery), and one month after surgery
|
Borg Score is a rating of perceived exertion which is a reliable indicator to monitor and guide exercise intensity.It allows individuals to subjectively rate their level of exertion during exercise testing.We would record patients' Borg Score after 6 minutes walking test
|
baseline (before the surgery), and one month after surgery
|
|
Complications incidence
Tidsramme: One month after surgery
|
Record the complications of patients after surgery.
|
One month after surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. maj 2020
Primær færdiggørelse (Forventet)
30. november 2021
Studieafslutning (Forventet)
30. december 2021
Datoer for studieregistrering
Først indsendt
30. december 2020
Først indsendt, der opfyldte QC-kriterier
3. juni 2021
Først opslået (Faktiske)
4. juni 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juni 2021
Sidst verificeret
1. maj 2021
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2020-ZJD-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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