Clinical trial NCT03838757: Maximal Exercise Capacity and Extra-pulmonary Characteristics in Patients With Lung Cancer With Complete Remission .
Official title: Maximal Exercise Capacity, Extra-pulmonary Characteristics and Physical Activity Levels in Patients With Lung Cancer With Complete Remission .
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Keywords: Lung cancer
Exercise capacity
Cardiopulmonary exercise test
Respiratory muscle strength
Physical activity
Pulmonary functions
Peripheral Muscle Strength
Quality of life
Sleep of quality
Dyspnea
Depression
Fatigue
Cough
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 20 patients with lung cancer were included in the patients group and 20 healthy individuals were included in the control group

Brief summary: While lung cancer are rare disease in the early 20th century, its incidence increased in parallel with the increase in smoking habits. It is the most common type of cancer in the world. Despite advances in the efficacy of chemotherapy and radiotherapy regimens, surgical resection is the most effective curative treatment modality to improve survival in non-small cell lung cancer. Pulmonary resection candidates are selected according to not only tumor type and stage, but also functional status, exercise capacity, underlying lung disorders and health-related quality of life assessments. Patients with lung cancer often have lung and heart comorbidities that affect the outcome of the outcome measures and restricts cancer treatment options. In patients with lung cancer, shortness of breath, physical inactivity, weakness in peripheral muscles and exercise intolerance are described. Pulmonary rehabilitation is a multidisciplinary treatment designed to improve exercise capacity, functional status, health-related quality of life and to reduce the attenuation of chronic shortness of breath and fatigue in patients with chronic lung problems.

In literature, the effect of surgery in patients with lung cancer on postoperative respiratory muscle strength is not clear. There is no study investigating the effect of chemotherapy and radiotherapy on respiratory muscle strength. For these reasons, the aim of the study was to evaluate the curative period of non-small cell lung cancer patients with reliability and validity assessment methods. The hypothesis of our study was; when compared with patients with lung cancer and healthy individuals, exercise capacity, respiratory and peripheral muscle strength, physical activity levels, sleep and quality of life of lung cancer patients are reduced; dyspnoea, fatigue, depression, cough and pain levels increase.

Detailed description: According to sample size calculation 20 lung with complete remission cancer patients and 20 healthy individuals were included in the study. Cross-sectional observational research. The demographic, physical and physiological characteristics were recorded from the patient files. Exercise capacity (using cardiopulmonary exercise testing), physical activity, pulmonary functions, respiratory and peripheral muscle strength, dyspnea and fatigue perception, depression, cough, pain and quality of life were evaluated. Primary outcome measurement is maximal exercise capacity. Secondary outcomes are respiratory and peripheral muscle strength, pulmonary functions, physical activity, dyspnea and fatigue perception, depression, cough, pain and quality of life.

Eligibility criteria: Inclusion Criteria:

* Patients with; Diagnosed with lung cancer Stage 1, stage 2 and stage 3 patients in lung cancer patients Clinically stable and Under standard medication patients were included.

Exclusion Criteria:

* Patients with Metastasis Orthopedic and neurological problems Acute infection Non-co-operable
* Healthy Subjects with Any diagnosed disease were excluded.

Primary outcomes:
measure: Maximal exercise capacity
timeFrame: Second day
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: First day
measure: Physical activity
timeFrame: First day
measure: Pulmonary function test
timeFrame: First day
measure: Inspiratory and Expiratory muscle strength (MIP, MEP)
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: First day
measure: Dyspnea
timeFrame: First day
measure: Fatigue Severity
timeFrame: First day
measure: Life Quality
timeFrame: First day
measure: Depression
timeFrame: First day
measure: Sleep of quality
timeFrame: First day
measure: Cough
timeFrame: First day
measure: Life Quality
timeFrame: Second day
Other outcomes:
Locations:
city: Yenimahalle
country: Turkey
facility: Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation
Study officials:
affiliation: Gazi University
name: Zeynep Pelin Dündar, MSc
role: STUDY_CHAIR
affiliation: Gazi University
name: Meral Boşnak Güçlü, Assoc. Prof
role: STUDY_DIRECTOR
affiliation: Gebze Medical Park Hospital
name: Aydın Çiltaş, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cukurambar/Ankara
name: Mustafa Benekli, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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citation: Granger CL, Parry SM, Edbrooke L, Denehy L. Deterioration in physical activity and function differs according to treatment type in non-small cell lung cancer - future directions for physiotherapy management. Physiotherapy. 2016 Sep;102(3):256-63. doi: 10.1016/j.physio.2015.10.007. Epub 2015 Oct 23.
citation: Arbane G, Douiri A, Hart N, Hopkinson NS, Singh S, Speed C, Valladares B, Garrod R. Effect of postoperative physical training on activity after curative surgery for non-small cell lung cancer: a multicentre randomised controlled trial. Physiotherapy. 2014 Jun;100(2):100-7. doi: 10.1016/j.physio.2013.12.002. Epub 2014 Feb 12.
citation: Hashmi A, Baciewicz FA Jr, Soubani AO, Gadgeel SM. Preoperative pulmonary rehabilitation for marginal-function lung cancer patients. Asian Cardiovasc Thorac Ann. 2017 Jan;25(1):47-51. doi: 10.1177/0218492316683757. Epub 2016 Dec 5.