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Completed

NCT Number: NCT04450719

Pulmonary and Extrapulmonary Impairments in Patients With Lung Cancer Awaiting Surgery

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 6-minute walk test (6-MWT)

    Time frame: 10 minutes

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

Secondary outcomes

  1. Pulmonary function test

    Time frame: 5 minutes

    Dynamic lung volume was measured using a spirometry. Obtained values were represented in percentages.

  2. Respiratory strength test

    Time frame: 10 minutes

    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.

  3. Physical activity measurement

    Time frame: 3 days

    For this evaluation, a metabolic holter was used.

  4. Dyspnea scale

    Time frame: 1 minute

    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).

  5. Quality of life scale

    Time frame: 2 minutes

    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.

  6. Peripheral muscle strength test

    Time frame: The test was performed during 10 minutes for each participant.

    A hand-held dynamometer was used to evaluate m. quadriceps femoris strength.

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 29, 2020
Registry last updated
Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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