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Complications During Rehabilitation StayNCT06118164

Effect of Pursed-lips Breathing Combined With Aerobic Walking Exercise on Oxygenation and Activity Endurance in Lung Cancer Patients After Lobectomy

A study testing pursing- lip breathing combined with aerobic walking exercise, pursing- lip breathing and aerobic walking exercise in people with Complications During Rehabilitation Stay, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Complications During Rehabilitation Stay
What is being tested?
pursing- lip breathing combined with aerobic walking exercise, pursing- lip breathing and aerobic walking exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTaiwan
Study dates
22 Apr 2020to 30 Jun 2022
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Asia University

    Taichung, Wufeng, 41354

Other trials in Taiwan

About this study

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.

Read the detailed description

An randomized controlled trial was used. Sixty eligible subjects from the Department of Thoracic Surgery of a regional hospital in central Taiwan participate in this study. A total of sixty subjects were randomly and equally assigned to the experimental group, control group I and control group II, to carry out postoperative both pursed lip breathing and aerobic walking exercise, pursed lip breathing, and aerobic walking exercise respectively. All three interventions were conducted 3 times a day, each lasting 15 minutes, from the 1st to 5th day after the operation. Pretests were done before the start of the three interventions on the first postoperative day, and posttests were done after the completion of the three interventions on the 5th postoperative day. Data including 6-minute walking test, Dyspnea Visual Analogue Scale, Rating scale of perceived exertion, peak expiratory flow rate and SpO2 were collected.

Being tested
pursing- lip breathing combined with aerobic walking exercise, pursing- lip breathing, aerobic walking exercise
Keywords
lung cancer, lobectomy, pursed-lip breathing, aerobic walking, oxygenation, exercise tolerance
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pursing- lip breathing combined with aerobic walking exerciseBehavioural

    pursing- lip breathing combined with aerobic walking exercise

  • pursing- lip breathingBehavioural

    pursing- lip breathing

  • aerobic walking exerciseBehavioural

    aerobic walking exercise

Study groups in NCT06118164
Study groupRoleWhat they receive
experimental group -pursing- lip breathing combined with aerobic walking exerciseExperimentalFor 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.
Receives: Behavioral: pursing- lip breathing combined with aerobic walking exercise
Control group 1-pursed-lip breathingActive comparatorFor 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.
Receives: Behavioral: pursing- lip breathing
Control group 2 -aerobic walking exerciseActive comparatorFor 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.
Receives: Behavioral: aerobic walking exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: pretests(before the start of the three interventions on the post-op day 1)

  2. 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.

    Measured: posttests(after the completion of the three interventions on the post-op day 5)

  3. 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.

    Measured: pretests(before the start of the three interventions on the post-op day 1)

  4. 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.

    Measured: posttests(after the completion of the three interventions on the post-op day 5)

  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.

    Measured: pretests(before the start of the three interventions on the post-op day 1)

  6. 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.

    Measured: posttests(after the completion of the three interventions on the post-op day 5)

  7. 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.

    Measured: pretests(before the start of the three interventions on the post-op day 1)

  8. 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.

    Measured: posttests(after the completion of the three interventions on the post-op day 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2023
  2. Study start22 Apr 2020
  3. Primary completion30 Jun 2022
  4. Study completion30 Jun 2022

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06118164
Sponsor's protocol ID
TaichungTCH
Status last verified
Nov 2023
First submitted
31 Oct 2023
Last updated
9 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28094848
  • 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.

    PubMed 30421260
  • 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.

    PubMed 31805526
  • 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.

    PubMed 30740452
  • 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.

    PubMed 28453808
  • 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.

    PubMed 26769017
  • 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.

    PubMed 28835249
  • 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.

    PubMed 28969859
  • 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.

    PubMed 33538338
  • 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.

    PubMed 26291007
  • 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.

    PubMed 30505565
  • 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.

    PubMed 26210931

Questions about this trial

What is this clinical trial studying?

A study testing pursing- lip breathing combined with aerobic walking exercise, pursing- lip breathing and aerobic walking exercise in people with Complications During Rehabilitation Stay, run by Taichung Tzu Chi Hospital at 1 site in Taiwan.

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 3 inclusion and 2 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: finished, as of the sponsor's last update on 9 Nov 2023. 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 Taiwan. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect on Postoperative Oxygenation in Lung Cancer Patients (time frame: pretests(before the start of the three interventions on the post-op day 1)). The study lists 8 primary outcomes in all. 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 NCT06118164, which also lists 12 linked publications.

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 9 Nov 2023.

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