Pulmonary and Extrapulmonary Impairments in Patients With Lung Cancer Awaiting Surgery

Study Overview
=================
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.

Official Title
-----------------
Exercise Capacity, Muscle Strength, Respiratory Characteristics, Physical Activity and Quality of Life in Patients With Lung Cancer Awaiting Surgery

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1: Patients with lung cancer<br>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<br>Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were performed in healthy individuals. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test (6-MWT) | Exercise capacity was evaluated with this test according to the guidelines. | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test | Dynamic lung volume was measured using a spirometry. Obtained values were represented in percentages. | 5 minutes | 
| Respiratory strength test | Respiratory muscle weakness was detected using volitional measurements of maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) via a portable mouth pressure device based on guidelines. Both MIP and MEP were represented with same units as cmH2O and percentages. | 10 minutes | 
| Physical activity measurement | For this evaluation, a metabolic holter was used. | 3 days | 
| Dyspnea scale | The Modified Medical Research Council (MMRC) dyspnea scale was used. Dyspnea levels are categorized between 0 (dyspnea only with strenuous exercise) and 4 (too breathless to leave the house or when dressing/undressing). | 1 minute | 
| Quality of life scale | European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 version3.0 (EORTC QLQ-C30) was used to evaluate aspects of quality of life impairment. Self-administered questionnaire incorporates five functional scales including social functioning subscale, three symptom scales including fatigue subscale, a global health status and several single items. All item scores are transformed to 0-100. Higher values represent higher functional/healthy level in functional scales, a higher quality of life level in global health status and increased presence of symptoms in symptom scales. | 2 minutes | 
| Peripheral muscle strength test | A hand-held dynamometer was used to evaluate m. quadriceps femoris strength. | The test was performed during 10 minutes for each participant. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, walk test, pulmonary functions, muscle strength, physical activity, quality of life