NCT06118164

Brief Summary

The effects of pursed-lip breathing or aerobic walking exercise in increasing muscle strength and motility and relieving dyspnea have been proved. However, patients with lung cancer often have decreased lung function and exercise capacity after lobectomy. The aim of this study was to explore the effects of pursed-lip breathing combined with aerobic walking exercise on postoperative oxygenation and exercise tolerance of lung cancer patients underwent lobectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 22, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

October 31, 2023

Last Update Submit

November 6, 2023

Conditions

Keywords

lung cancerlobectomypursed-lip breathingaerobic walkingoxygenationexercise tolerance

Outcome Measures

Primary Outcomes (8)

  • Effect on Postoperative Oxygenation in Lung Cancer Patients

    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

    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

    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

    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

    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

    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

    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

    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)

Study Arms (3)

experimental group -pursing- lip breathing combined with aerobic walking exercise

EXPERIMENTAL

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) Ă— 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.

Behavioral: pursing- lip breathing combined with aerobic walking exercise

Control group 1-pursed-lip breathing

ACTIVE COMPARATOR

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.

Behavioral: pursing- lip breathing

Control group 2 -aerobic walking exercise

ACTIVE COMPARATOR

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.

Behavioral: aerobic walking exercise

Interventions

pursing- lip breathing combined with aerobic walking exercise

experimental group -pursing- lip breathing combined with aerobic walking exercise

pursing- lip breathing

Control group 1-pursed-lip breathing

aerobic walking exercise

Control group 2 -aerobic walking exercise

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asia University

Taichung, Wufeng, 41354, Taiwan

Location

Related Publications (12)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hua-Shan Wu, PhD

    Asia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Patients who agreed to participate were randomly assigned to the experimental group or one of the two control groups (Control I and Control II) by outpatient nurses drawing lots from a lottery box. Once the group assignment was determined, on the day of admission, the researchers provided instructions on the respective intervention measures for that group (Pursed-lip breathing combined with aerobic walking exercise group, Pursed-lip breathing only group, Aerobic walking exercise only group). Data collection was carried out by registered nurses with at least two years of clinical experience in non-enrollment wards.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: The experimental group was given pursed-mouth breathing training combined with aerobic walking exercise. Control group I was given pursed-mouth breathing training. Control group II was given aerobic walking exercise.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Thoracic Surgery

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 7, 2023

Study Start

April 22, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations