Maximal Exercise Capacity and Extra-pulmonary Characteristics in Patients With Lung Cancer With Complete Remission .

Lung Cancer Clinical Trial

Official title:

Maximal Exercise Capacity, Extra-pulmonary Characteristics and Physical Activity Levels in Patients With Lung Cancer With Complete Remission .

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03838757
• Other study ID #: Gaziuniversity13
• Status: Completed
• Start date: December 31, 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2019
• Source: Gazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
Turkey	Gazi University Faculty of Health Sciences Department of Physical Therapy and Rehabilitation	Yenimahalle

Sponsors (1)

Lead Sponsor	Collaborator
Gazi University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

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 — View Citation

Cavalheri V, Jenkins S, Cecins N, Gain K, Hill K. Comparison of the six-minute walk test with a cycle-based cardiopulmonary exercise test in people following curative intent treatment for non-small cell lung cancer. Chron Respir Dis. 2016 May;13(2):118-27 — View 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: 10.1 — View Citation

Granger CL, Denehy L, Parry SM, Martin J, Dimitriadis T, Sorohan M, Irving L. Which field walking test should be used to assess functional exercise capacity in lung cancer? An observational study. BMC Pulm Med. 2015 Aug 12;15:89. doi: 10.1186/s12890-015-0 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal exercise capacity	Cardiopulmonary exercise testing (Oxygen consumption measurement during test).	Second day
Secondary	Functional exercise capacity	The six-minute walking test (6-MWT) was used to evaluate submaximal exercise capacity.	First day
Secondary	Physical activity	Physical activity will be evaluated multi sensor activity monitor for 2 consecutive days.	First day
Secondary	Pulmonary function test	This test was evaluated using a spirometry by which is evaluated dynamic lung functions expressed as percentages of expected values.	First day
Secondary	Inspiratory and Expiratory muscle strength (MIP, MEP)	Respiratory muscle strength was evaluated with a mouth pressure device	First day
Secondary	Peripheral muscle strength	Peripheral muscle strength was evaluated with a hand-held dynamometer.	First day
Secondary	Dyspnea	The severity of dyspnea during daily living activities was evaluated using the Modified Medical Research Council (MMRC) dyspnea scale. Dyspnea is graded as follows: zero (dyspnea only with strenuous exercise), one (dyspnea when hurrying or walking up a slight hill), two (walks slower than people of the same age due to dyspnea or having to stop for breath when walking at own pace), three (stops for breath after walking 100 yards or after a few minutes) and four (too dyspneic to leave house or breathless when dressing). The minimal clinically important difference (MCID) is 1 unit for the MMRC dyspnea scale.	First day
Secondary	Fatigue Severity	The Turkish version of Fatigue Severity Scale, which is a valid and reliable test, was performed to the recipients for evaluation of fatigue severity. Self-administered questionnaire is comprised of nine questions. The average score is identified on seven-point scale. Patients select a number from 1 to 7 for each 9 questions which demonstrates from strong disagreement to strong agreement, respectively. The cut-off score for fatigue severity is 36 according to this scale, if the total score obtained from this scale is higher than 36, the recipient is defined as severe fatigue.	First day
Secondary	Life Quality	Quality of life was measured using Turkish version of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version 3.0 (EORTCQLQ) which is widely used as health related quality of life questionnaire in cancer patients. The cancer-specific questionnaire has 30 questions and incorporates five functional scales, three symptom scales, a global health status and several single items. All item scores are transformed to 0-100. Higher values indicate higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased symptoms in symptom scales.	First day
Secondary	Depression	Montgomery Asberg Depression Rating Scale (MADRS) (Turkish version of scale) This assessment tool contains 10 items with a score from 0 to 6, thus the maximum score is 60. A higher score indicates a more severe depression.	First day
Secondary	Sleep of quality	Sleep quality of the individuals was evaluated with the Turkish version of Pittsburgh Sleep Quality Index. It is an individual evaluation scale that evaluates sleep quality and sleep disturbance in the last one month period.	First day
Secondary	Cough	The Turkish version of the Leicester Cough Scale (LÖQ) was used to assess the health-related quality of life of individuals with chronic cough. The scale evaluates chronic cough consisting of 19 items, including physical (8 items), psychosocial (7 items) and social (4 items) subsections. Each item is scored between 1 (always) and 7 (never). The total score is 3-21 points. The high scores obtained from this questionnaire, which evaluates the effect of the symptoms that have been going on for the last two weeks, show less impact on cough and lower scores indicate more impact.	First day
Secondary	Life Quality	Functional Assessment of Cancer Therapy - Lung cancer Quality of life questionnaire (Turkish version) is used to assess the quality of life of lung cancer patients from many cultures all over the world. It is an individual applied scale and consists of 36 questions specific to lung cancer. Body is a scale consisting of 5 subsections including status, social life and family situation, emotional state, activity status and other concerns.	Second day