Clinical trial NCT04450719: Pulmonary and Extrapulmonary Impairments in Patients With Lung Cancer Awaiting Surgery
Official title: Exercise Capacity, Muscle Strength, Respiratory Characteristics, Physical Activity and Quality of Life in Patients With Lung Cancer Awaiting Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: lung cancer
walk test
pulmonary functions
muscle strength
physical activity
quality of life
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-06-29
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_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.

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.

Detailed description: According to global cancer statistics, the most commonly diagnosing and the highest mortality rates belong to lung cancer. As known, patients with lung cancer suffer from many pathophysiological changes due to characteristics of the lung cancer and its cytotoxic treatments including chemotherapy and radiotherapy. Especially, these changes commonly occur in respiratory mechanics and gas exchange all of which resulted in pulmonary function impairment. Moreover, excessive weight loss, anemia, protein catabolism, muscle wasting, skeletal muscle atrophy and inhibition of muscle regeneration are observed in these patients in course of time.

The 6-minute walk test provides valuable and valid knowledge about exercise intolerance in diseases. As known, progressive decline in exercise capacity is commonly observed in patients with lung cancer. The loss of muscle mass also happens not only peripheral muscle but also respiratory muscles in patients with lung cancer. Based on the limited studies regarding patients with lung cancer, weakness in respiratory muscles before surgery has been demonstrated. Furthermore, these patients experience fatigue and dyspnea perceptions all of which increase disease burden and afflict quality of life.

According to the results of a study compared the patients with lung cancer before surgery and healthy individuals, the patients are less physically active than healthy individuals. Moreover, at the diagnosis stage, the patients have worse quadriceps muscle strength, nutritional status, mood and quality of life compared to others. After six months, the patients experience decreases in physical activity, 6-minute walk test distance, and muscle strength and worsening symptoms following chemotherapy, radiotherapy and/or surgery. On the other hand, it could not be clearly demonstrated in the literature to the amount of impairments of pulmonary function and respiratory muscle strength compared to healthy individuals.

To reveal aforementioned impairments in patients with lung cancer before surgery is of importance in terms of being helpful in both determining the protective rehabilitation program and also reducing the disease burden and other possible factors in lung cancer. Therefore, the aim of the current study was to investigate the differences in exercise capacity, pulmonary functions, respiratory and peripheral muscle strength, physical activity level, dyspnea, fatigue and quality of life between the patients with lung cancer before lung surgery and gender and age-matched healthy individuals.

Eligibility criteria: Inclusion Criteria for patients:

* 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.

Exclusion Criteria for patients:

* 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.

Inclusion Criteria for healthy individuals:

* being 18-80 years of age,
* willing to participate to the study,
* being individuals without known and diagnosed any chronic diseases.

Exclusion Criteria for healthy individuals:

* being current smokers,
* being ex-smokers (≥10 pack\*years).

Primary outcomes:
measure: 6-minute walk test (6-MWT)
timeFrame: 10 minutes
Secondary outcomes:
measure: Pulmonary function test
timeFrame: 5 minutes
measure: Respiratory strength test
timeFrame: 10 minutes
measure: Physical activity measurement
timeFrame: 3 days
measure: Dyspnea scale
timeFrame: 1 minute
measure: Quality of life scale
timeFrame: 2 minutes
measure: Peripheral muscle strength test
timeFrame: The test was performed during 10 minutes for each participant.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation
Study officials:
affiliation: İzmir Democracy University
name: Gülşah Barğı, PhD
role: STUDY_CHAIR
affiliation: Gazi University
name: Ece Baytok, MsC
role: STUDY_CHAIR
affiliation: Gazi University
name: Zeliha Çelik, MsC
role: STUDY_CHAIR
affiliation: Gazi University
name: Merve Şatır Türk, MD
role: STUDY_CHAIR
affiliation: Gazi University
name: Ali Çelik, Prof. Dr.
role: STUDY_CHAIR
affiliation: Gazi University
name: İsmail Cüneyt Kurul, Prof. Dr.
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.