- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06118164
Effect of Pursed-lips Breathing Combined With Aerobic Walking Exercise on Oxygenation and Activity Endurance in Lung Cancer Patients After Lobectomy
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Wufeng
-
Taichung, Wufeng, Taiwan, 41354
- Asia University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Participants aged over 20 who have been informed of the research process and are willing to participate and sign consent.
- Participants with clear consciousness, the ability to communicate in Mandarin or Taiwanese, and the ability to walk independently.
- Participants diagnosed with lung cancer who have undergone lung lobe resection surgery.
Exclusion Criteria:
- Changes in the surgical plan, not undergoing at least a single lung lobe resection.
- Deterioration of postoperative condition, making it impossible to correctly perform pursed lip breathing or aerobic walking exercises.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: experimental group -pursing- lip breathing combined with aerobic walking exercise
For the pursed-lip breathing combined with aerobic walking exercise group (experimental group), subjects were taught to coordinate their breathing with their walking. They were instructed to inhale for two steps and exhale with pursed lips for four to five steps. Initially, they were allowed to walk at a pace that felt comfortable to them, and then gradually increase their walking speed until they reached the target aerobic heart rate, calculated using the formula: (220 - age) × 55-65% of maximum heart rate. During the walking exercise, a pulse oximeter was used to monitor their heart rate and blood oxygen saturation. Training sessions were conducted daily from the first day after surgery until the fifth day, with three sessions each day, and each session lasting for 15 minutes. |
pursing- lip breathing combined with aerobic walking exercise
|
|
Active Comparator: Control group 1-pursed-lip breathing
For the group receiving single pursing- lip breathing training (control group 1), subjects were taught to perform deep inhalation through the nose (counting mentally from 1 to 2) while in a seated or standing position. They were then instructed to purse their lips and exhale slowly and steadily (counting mentally from 1 to 4). During the walking exercise, a pulse oximeter was used to monitor their heart rate and blood oxygen saturation. Training sessions were conducted daily from the first day after surgery until the fifth day, with three sessions each day, and each session lasting for 15 minutes. |
pursing- lip breathing
|
|
Active Comparator: Control group 2 -aerobic walking exercise
For the single aerobic walking exercise group (control group 2), subjects were taught to start with their own acceptable stride and pace and then gradually increase their walking speed until they reached the target aerobic heart rate. Pulse oximeters were used to monitor their heart rate and blood oxygen saturation levels during the process. During the walking exercise, a pulse oximeter was used to monitor their heart rate and blood oxygen saturation. Training sessions were conducted daily from the first day after surgery until the fifth day, with three sessions each day, and each session lasting for 15 minutes. |
aerobic walking exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect on Postoperative Oxygenation in Lung Cancer Patients
Time Frame: pretests(before the start of the three interventions on the post-op day 1)
|
Measurements were taken on the 1st day after surgery, prior to the intervention.
The pulse oximeter was placed on the patient's fingertip, and after a 5-second wait, the SpO2 value appeared on the monitor interface, which was then recorded on the data sheet.
|
pretests(before the start of the three interventions on the post-op day 1)
|
|
Effect on Postoperative Oxygenation in Lung Cancer Patients
Time Frame: posttests(after the completion of the three interventions on the post-op day 5)
|
Measurements were taken on the 5th day after surgery, after three activities.
The pulse oximeter was placed on the patient's fingertip, and after a 5-second wait, the SpO2 value appeared on the monitor interface, which was then recorded on the data sheet.
|
posttests(after the completion of the three interventions on the post-op day 5)
|
|
Effect on Postoperative Oxygenation in Lung Cancer Patients
Time Frame: pretests(before the start of the three interventions on the post-op day 1)
|
Dyspnea Visual Analogue Scale (DVAS):Draw a vertical 10 cm line on an A4 white paper. Label the top end of the line as "Not Breathless" and the bottom end as "Very Breathless." The longer the distance marked on the line, the more severe the breathlessness. Measurement Method: Measurements were taken on the 1st day after surgery, prior to the intervention. After the patient completes a six-minute walk test, they mark their level of breathlessness on the vertical line to assess the degree of breathlessness. |
pretests(before the start of the three interventions on the post-op day 1)
|
|
Effect on Postoperative Oxygenation in Lung Cancer Patients
Time Frame: posttests(after the completion of the three interventions on the post-op day 5)
|
Dyspnea Visual Analogue Scale (DVAS): Draw a vertical 10 cm line on an A4 white paper. Label the top end of the line as "Not Breathless" and the bottom end as "Very Breathless." The longer the distance marked on the line, the more severe the breathlessness. Measurement Method: Measurements were taken on the 5th day after surgery, after three activities. After the patient completes a six-minute walk test, they mark their level of breathlessness on the vertical line to assess the degree of breathlessness. |
posttests(after the completion of the three interventions on the post-op day 5)
|
|
Effect on Postoperative activity endurance in Lung Cancer Patients
Time Frame: pretests(before the start of the three interventions on the post-op day 1)
|
Six-minute walking test (6MWT) : A long, flat, unobstructed hospital corridor is selected as the testing location.
The floor is marked every 1 meter, covering a total distance of 30 meters.
Patients are instructed to walk back and forth within the marked distance.
Before the test, patients are informed to walk at the fastest pace they can tolerate and that they can slow down or pause if they experience any physical discomfort during the test.
The test lasts for six minutes, and when the time is up, patients stop walking.
The location where patients stop is recorded, corresponding to a marked point on the floor.
The distances covered are summed up to determine the test result.
|
pretests(before the start of the three interventions on the post-op day 1)
|
|
Effect on Postoperative activity endurance in Lung Cancer Patients
Time Frame: posttests(after the completion of the three interventions on the post-op day 5)
|
Six-minute walking test (6MWT) : A long, flat, unobstructed hospital corridor is selected as the testing location.
The floor is marked every 1 meter, covering a total distance of 30 meters.
Patients are instructed to walk back and forth within the marked distance.
Before the test, patients are informed to walk at the fastest pace they can tolerate and that they can slow down or pause if they experience any physical discomfort during the test.
The test lasts for six minutes, and when the time is up, patients stop walking.
The location where patients stop is recorded, corresponding to a marked point on the floor.
The distances covered are summed up to determine the test result.
Measurements were taken on the 1st day after surgery before the intervention.
|
posttests(after the completion of the three interventions on the post-op day 5)
|
|
Effect on Postoperative activity endurance in Lung Cancer Patients
Time Frame: pretests(before the start of the three interventions on the post-op day 1)
|
Rating scale of perceived exertion (RPE / Borg 6-20):This scale ranges from 6 points (indicating no perceived exertion) to 20 points (indicating maximal exertion).
Higher scores indicate a higher level of perceived exertion.Measurements were taken on the 1st day after surgery before the intervention.
After the six-minute walking test, patients were asked to circle the score on the scale that corresponds to their perceived level of exertion to assess the level of exertion felt by patients after activity.
|
pretests(before the start of the three interventions on the post-op day 1)
|
|
Effect on Postoperative activity endurance in Lung Cancer Patients
Time Frame: posttests(after the completion of the three interventions on the post-op day 5)
|
Rating scale of perceived exertion (RPE / Borg 6-20):This scale ranges from 6 points (indicating no perceived exertion) to 20 points (indicating maximal exertion).
Higher scores indicate a higher level of perceived exertion.Measurements were taken on the 5th day after surgery after three separate activities.
Following the six-minute walking test, patients were asked to circle the score on the scale that corresponds to their perceived level of exertion to assess the level of exertion felt by patients after activity.
|
posttests(after the completion of the three interventions on the post-op day 5)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hua-Shan Wu, PhD, Asia University
Publications and helpful links
General Publications
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Travis WD, Brambilla E, Burke AP, Marx A, Nicholson AG. Introduction to The 2015 World Health Organization Classification of Tumors of the Lung, Pleura, Thymus, and Heart. J Thorac Oncol. 2015 Sep;10(9):1240-1242. doi: 10.1097/JTO.0000000000000663. No abstract available.
- Amin MB, Greene FL, Edge SB, Compton CC, Gershenwald JE, Brookland RK, Meyer L, Gress DM, Byrd DR, Winchester DP. The Eighth Edition AJCC Cancer Staging Manual: Continuing to build a bridge from a population-based to a more "personalized" approach to cancer staging. CA Cancer J Clin. 2017 Mar;67(2):93-99. doi: 10.3322/caac.21388. Epub 2017 Jan 17.
- Abbas AE. Surgical Management of Lung Cancer: History, Evolution, and Modern Advances. Curr Oncol Rep. 2018 Nov 13;20(12):98. doi: 10.1007/s11912-018-0741-7.
- Ettinger DS, Wood DE, Aggarwal C, Aisner DL, Akerley W, Bauman JR, Bharat A, Bruno DS, Chang JY, Chirieac LR, D'Amico TA, Dilling TJ, Dobelbower M, Gettinger S, Govindan R, Gubens MA, Hennon M, Horn L, Lackner RP, Lanuti M, Leal TA, Lin J, Loo BW Jr, Martins RG, Otterson GA, Patel SP, Reckamp KL, Riely GJ, Schild SE, Shapiro TA, Stevenson J, Swanson SJ, Tauer KW, Yang SC, Gregory K; OCN; Hughes M. NCCN Guidelines Insights: Non-Small Cell Lung Cancer, Version 1.2020. J Natl Compr Canc Netw. 2019 Dec;17(12):1464-1472. doi: 10.6004/jnccn.2019.0059.
- Granger CL, Edbrooke L, Denehy L. The nexus of functional exercise capacity with health-related quality of life in lung cancer: how closely are they related? Ann Transl Med. 2018 Dec;6(Suppl 2):S131. doi: 10.21037/atm.2018.12.35. No abstract available.
- Kobayashi N, Kobayashi K, Kikuchi S, Goto Y, Ichimura H, Endo K, Sato Y. Long-term pulmonary function after surgery for lung cancer. Interact Cardiovasc Thorac Surg. 2017 May 1;24(5):727-732. doi: 10.1093/icvts/ivw414.
- Lugg ST, Agostini PJ, Tikka T, Kerr A, Adams K, Bishay E, Kalkat MS, Steyn RS, Rajesh PB, Thickett DR, Naidu B. Long-term impact of developing a postoperative pulmonary complication after lung surgery. Thorax. 2016 Feb;71(2):171-6. doi: 10.1136/thoraxjnl-2015-207697.
- Li J, Guo NN, Jin HR, Yu H, Wang P, Xu GG. Effects of exercise training on patients with lung cancer who underwent lung resection: a meta-analysis. World J Surg Oncol. 2017 Aug 23;15(1):158. doi: 10.1186/s12957-017-1233-1.
- Mayer AF, Karloh M, Dos Santos K, de Araujo CLP, Gulart AA. Effects of acute use of pursed-lips breathing during exercise in patients with COPD: a systematic review and meta-analysis. Physiotherapy. 2018 Mar;104(1):9-17. doi: 10.1016/j.physio.2017.08.007. Epub 2017 Aug 31.
- Villeneuve PJ. Interventions to avoid pulmonary complications after lung cancer resection. J Thorac Dis. 2018 Nov;10(Suppl 32):S3781-S3788. doi: 10.21037/jtd.2018.09.26.
- Ziarnik E, Grogan EL. Postlobectomy Early Complications. Thorac Surg Clin. 2015 Aug;25(3):355-64. doi: 10.1016/j.thorsurg.2015.04.003. Epub 2015 Jun 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TaichungTCH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Complications During Rehabilitation Stay
-
University Hospital of North NorwayCompletedPsychiatric Patients Experiences of Vocational Rehabilitation During Admittance in HospitalNorway
-
Dr. Lutfi Kirdar Kartal Training and Research HospitalNot yet recruitingOperative Time | Length of Hospital Stay | Perioperative Complications
-
Hayat Abad Medical Complex, Peshawar.Active, not recruitingPyeloplasty | Hospital Stay | Complications of Surgical Procedures or Medical CarePakistan
-
LTBIO Co., Ltd.Samsung Medical Center; Korea University Anam Hospital; Inje University; Gangnam... and other collaboratorsNot yet recruitingPostoperative Pain Management During Rehabilitation in Patients Undergoing Total Knee Arthroplasty
-
Universitätsklinikum Hamburg-EppendorfUniversity of Kiel; University of Valencia; University of Witten/Herdecke; Szeged... and other collaboratorsCompletedReduction of Length of Hospitality Stay, Reduction of Perioperative ComplicationsGermany
-
Ling CuiCompletedPostoperative Complications | Length of Stay | CRPChina
-
Shanghai Zhongshan HospitalUnknownPostoperative Complications | Morality | Length of Stay
-
Swansea Bay University Health BoardRecruitingCancer | Lung Resection | Inspiratory Muscle Training | Prehabilitation | Respiratory Complications | Length of Hospital StayUnited Kingdom
-
University Hospital, LinkoepingCompletedPostoperative Complications | Hydration | Hospital Stay | Bioelectrical Impedance
-
St. Anne's University Hospital Brno, Czech RepublicRecruitingPostoperative Complications | Length of Hospital Stay | Postoperative OutcomesCzechia
Clinical Trials on pursing- lip breathing combined with aerobic walking exercise
-
Chulalongkorn UniversityCompletedSmoking Cessation | Smoker LungThailand
-
Khon Kaen UniversityCompleted
-
University of PretoriaNot yet recruitingMajor Depressive Disorder (MDD)Saudi Arabia
-
National Cheng Kung UniversityNot yet recruiting
-
Riphah International UniversityCompleted
-
Capital University of Physical Education and Sports...CompletedObese College Students | Aerobic Exercise Combined with Resistance ExerciseChina
-
Kocaeli UniversityRecruitingCardiac SurgeryTurkey (Türkiye)
-
Hasan Kalyoncu UniversityNot yet recruiting
-
Taipei Veterans General Hospital, TaiwanEnrolling by invitationHyperglycemia | Quality of Life | Diabetic Foot | Wound Healing | Resistance Exercise
-
Hacettepe UniversityCompleted