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Pulmonary and Extrapulmonary Impairments in Patients With Lung Cancer Awaiting Surgery

2020년 6월 25일 업데이트: 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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (실제)

47

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

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.

설명

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).

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
6-minute walk test (6-MWT)
기간: 10 minutes
Exercise capacity was evaluated with this test according to the guidelines.
10 minutes

2차 결과 측정

결과 측정
측정값 설명
기간
신체 활동 측정
기간: 3 일
이 평가를 위해 대사 홀터를 사용했습니다.
3 일
Pulmonary function test
기간: 5 minutes
Dynamic lung volume was measured using a spirometry. Obtained values were represented in percentages.
5 minutes
Respiratory strength test
기간: 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
기간: 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
기간: 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
기간: 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.

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2018년 7월 10일

기본 완료 (실제)

2019년 6월 17일

연구 완료 (실제)

2019년 7월 26일

연구 등록 날짜

최초 제출

2020년 6월 1일

QC 기준을 충족하는 최초 제출

2020년 6월 25일

처음 게시됨 (실제)

2020년 6월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2020년 6월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2020년 6월 25일

마지막으로 확인됨

2020년 6월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

폐암에 대한 임상 시험

3
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