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Pulmonary and Extrapulmonary Impairments in Patients With Lung Cancer Awaiting Surgery

25 de junio de 2020 actualizado por: Meral Boşnak Güçlü, Gazi University

Exercise Capacity, Muscle Strength, Respiratory Characteristics, Physical Activity and Quality of Life 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

47

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Ankara, Pavo, 06010
        • Gazi University Faculty of Health Science Department of Physiotherapy and Rehabilitation

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 80 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Group 1: Patients with lung cancer
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
Healthy individuals were selected from individuals without known and diagnosed any chronic diseases. Similar measurements were performed in healthy individuals.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
6-minute walk test (6-MWT)
Periodo de tiempo: 10 minutes
Exercise capacity was evaluated with this test according to the guidelines.
10 minutes

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Medición de la actividad física
Periodo de tiempo: 3 días
Para esta evaluación se utilizó un holter metabólico.
3 días
Pulmonary function test
Periodo de tiempo: 5 minutes
Dynamic lung volume was measured using a spirometry. Obtained values were represented in percentages.
5 minutes
Respiratory strength test
Periodo de tiempo: 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.
10 minutes
Dyspnea scale
Periodo de tiempo: 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).
1 minute
Quality of life scale
Periodo de tiempo: 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.
2 minutes
Peripheral muscle strength test
Periodo de tiempo: The test was performed during 10 minutes for each participant.
A hand-held dynamometer was used to evaluate m. quadriceps femoris strength.
The test was performed during 10 minutes for each participant.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Silla de estudio: Ece BAYTOK, MsC, Gazi University
  • Silla de estudio: Zeliha Çelik, MsC, Gazi University
  • Silla de estudio: Gülşah Barğı, PhD, Izmir Democracy University
  • Silla de estudio: Merve Şatır Türk, MD, Gazi University
  • Silla de estudio: Ali Çelik, Prof. Dr., Gazi University
  • Silla de estudio: İsmail Cüneyt Kurul, Prof. Dr., Gazi University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

10 de julio de 2018

Finalización primaria (Actual)

17 de junio de 2019

Finalización del estudio (Actual)

26 de julio de 2019

Fechas de registro del estudio

Enviado por primera vez

1 de junio de 2020

Primero enviado que cumplió con los criterios de control de calidad

25 de junio de 2020

Publicado por primera vez (Actual)

29 de junio de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de junio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

25 de junio de 2020

Última verificación

1 de junio de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

There is not a plan to make individual participant data but when the statistical analyses of all data are made, all results will be shared.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Cáncer de pulmón

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