NCT04450719

Brief Summary

To detect comparatively the extent to which physical impairments are observed in patients with lung cancer awaiting lung surgery, comparing exercise capacity, pulmonary functions, muscle strength, physical activity, dyspnea, fatigue and quality of life between the patients with lung cancer and healthy individuals was aimed in current study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2018

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

July 10, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 1, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

June 29, 2020

Completed
Last Updated

June 29, 2020

Status Verified

June 1, 2020

Enrollment Period

11 months

First QC Date

June 1, 2020

Last Update Submit

June 25, 2020

Conditions

Keywords

lung cancerwalk testpulmonary functionsmuscle strengthphysical activityquality of life

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk test (6-MWT)

    Exercise capacity was evaluated with this test according to the guidelines.

    10 minutes

Secondary Outcomes (6)

  • Pulmonary function test

    5 minutes

  • Respiratory strength test

    10 minutes

  • Physical activity measurement

    3 days

  • Dyspnea scale

    1 minute

  • Quality of life scale

    2 minutes

  • +1 more secondary outcomes

Study Arms (2)

Group 1: Patients with lung cancer

Exercise capacity \[6-minute walk test (6-MWT)\], pulmonary functions \[spirometry\], respiratory \[maximal inspiratory and expiratory pressures (MIP-MEP), mouth pressure device\] and peripheral muscle strength \[dynamometer\], physical activity level \[metabolic holter\], dyspnea \[Modified Medical Research Council dyspnea scale (MMRC)\] and quality of life \[European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTCQOL)\] were evaluated in patients with lung cancer. Vital signs, dyspnea and fatigue perception \[Modified Borg Scale\] were recorded as pre-post measurements of 6-MWT.

Group 2: Healthy individuals

Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were performed in healthy individuals.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Twenty six patients with lung cancer and 21 healthy individuals were included in this study. All patients were referred from Gazi University, Faculty of Medicine, Department of Thoracic Surgery to Gazi University, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation. The patients with lung cancer who were decided to undergo lung surgery by thoracic surgeons were referred to the physiotherapist. Healthy volunteers were also recruited. Then, the patients were matched with healthy individuals according to statistically similarity of both age and gender.

You may qualify if:

  • being between ages of 18 and 80,
  • being a candidate for lung surgery due to lung cancer diagnosis,
  • being able to walk,
  • receiving optimal medical therapy.

You may not qualify if:

  • having health problems such as cooperation,
  • having orthopedic or neurological disease that limit the walking ability and physical activity,
  • having comorbidities such as uncontrolled diabetes mellitus, heart failure, atrial fibrillation and/or hypertension, acute infections,
  • having myocardial infarction in the last six months.
  • being 18-80 years of age,
  • willing to participate to the study,
  • being individuals without known and diagnosed any chronic diseases.
  • being current smokers,
  • being ex-smokers (≥10 pack\*years).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, 06010, Turkey (Türkiye)

Location

Related Publications (15)

  • Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.

  • Jones LW, Eves ND, Haykowsky M, Freedland SJ, Mackey JR. Exercise intolerance in cancer and the role of exercise therapy to reverse dysfunction. Lancet Oncol. 2009 Jun;10(6):598-605. doi: 10.1016/S1470-2045(09)70031-2.

  • Travers J, Dudgeon DJ, Amjadi K, McBride I, Dillon K, Laveneziana P, Ofir D, Webb KA, O'Donnell DE. Mechanisms of exertional dyspnea in patients with cancer. J Appl Physiol (1985). 2008 Jan;104(1):57-66. doi: 10.1152/japplphysiol.00653.2007. Epub 2007 Nov 1.

  • Cavalheri V, Jenkins S, Cecins N, Gain K, Phillips M, Sanders LH, Hill K. Impairments after curative intent treatment for non-small cell lung cancer: a comparison with age and gender-matched healthy controls. Respir Med. 2015 Oct;109(10):1332-9. doi: 10.1016/j.rmed.2015.08.015. Epub 2015 Aug 29.

  • Pinson P, Klastersky J. The value of lung function measurements for the assessment of chemotherapy in lung cancer patients. Lung Cancer. 1998 Mar;19(3):179-84. doi: 10.1016/s0169-5002(97)00094-9.

  • Granger CL, McDonald CF, Irving L, Clark RA, Gough K, Murnane A, Mileshkin L, Krishnasamy M, Denehy L. Low physical activity levels and functional decline in individuals with lung cancer. Lung Cancer. 2014 Feb;83(2):292-9. doi: 10.1016/j.lungcan.2013.11.014. Epub 2013 Nov 26.

  • Sullivan MJ, Green HJ, Cobb FR. Altered skeletal muscle metabolic response to exercise in chronic heart failure. Relation to skeletal muscle aerobic enzyme activity. Circulation. 1991 Oct;84(4):1597-607. doi: 10.1161/01.cir.84.4.1597.

  • Wagner PD. The major limitation to exercise performance in COPD is inadequate energy supply to the respiratory and locomotor muscles vs. lower limb muscle dysfunction vs. dynamic hyperinflation. The real cause of exercise limitation in COPD. J Appl Physiol (1985). 2008 Aug;105(2):758. doi: 10.1152/japplphysiol.90336.2008c. No abstract available.

  • Solway S, Brooks D, Lacasse Y, Thomas S. A qualitative systematic overview of the measurement properties of functional walk tests used in the cardiorespiratory domain. Chest. 2001 Jan;119(1):256-70. doi: 10.1378/chest.119.1.256.

  • Granger CL, Holland AE, Gordon IR, Denehy L. Minimal important difference of the 6-minute walk distance in lung cancer. Chron Respir Dis. 2015 May;12(2):146-54. doi: 10.1177/1479972315575715. Epub 2015 Mar 6.

  • Laude EA, Duffy NC, Baveystock C, Dougill B, Campbell MJ, Lawson R, Jones PW, Calverley PM. The effect of helium and oxygen on exercise performance in chronic obstructive pulmonary disease: a randomized crossover trial. Am J Respir Crit Care Med. 2006 Apr 15;173(8):865-70. doi: 10.1164/rccm.200506-925OC. Epub 2006 Jan 26.

  • Nomori H, Horio H, Fuyuno G, Kobayashi R, Yashima H. Respiratory muscle strength after lung resection with special reference to age and procedures of thoracotomy. Eur J Cardiothorac Surg. 1996;10(5):352-8. doi: 10.1016/s1010-7940(96)80094-7.

  • Weiner P, Man A, Weiner M, Rabner M, Waizman J, Magadle R, Zamir D, Greiff Y. The effect of incentive spirometry and inspiratory muscle training on pulmonary function after lung resection. J Thorac Cardiovasc Surg. 1997 Mar;113(3):552-7. doi: 10.1016/S0022-5223(97)70370-2.

  • Bower JE. Cancer-related fatigue--mechanisms, risk factors, and treatments. Nat Rev Clin Oncol. 2014 Oct;11(10):597-609. doi: 10.1038/nrclinonc.2014.127. Epub 2014 Aug 12.

  • Fox SW, Lyon DE. Symptom clusters and quality of life in survivors of lung cancer. Oncol Nurs Forum. 2006 Sep 1;33(5):931-6. doi: 10.1188/06.ONF.931-936.

MeSH Terms

Conditions

Lung NeoplasmsMotor Activity

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesBehavior

Study Officials

  • Gülşah Barğı, PhD

    İzmir Democracy University

    STUDY CHAIR
  • Ece Baytok, MsC

    Gazi University

    STUDY CHAIR
  • Zeliha Çelik, MsC

    Gazi University

    STUDY CHAIR
  • Merve Şatır Türk, MD

    Gazi University

    STUDY CHAIR
  • Ali Çelik, Prof. Dr.

    Gazi University

    STUDY CHAIR
  • İsmail Cüneyt Kurul, Prof. Dr.

    Gazi University

    STUDY CHAIR
  • Meral Boşnak Güçlü, Prof. Dr.

    Gazi University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 1, 2020

First Posted

June 29, 2020

Study Start

July 10, 2018

Primary Completion

June 17, 2019

Study Completion

July 26, 2019

Last Updated

June 29, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.

Locations