- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04803617
Investigation of Pectoralis Muscle Strength in Elderly With Interstitial Lung Disease
2021년 3월 16일 업데이트: Habibedurdu
The Effect of Pectoralis Muscle Strength on Pulmonary Function in Elderly With Interstitial Lung Disease
Interstitial lung disease (ILD) is a restrictive lung disease characterized by impaired lung function, exercise limitation and skeletal muscle dysfunction.
There is limited data on skeletal muscle function in ILD, most of which are focused on the lower limb muscles.
The aim of this study were to evaluated the change of pectoralis muscle strength and relationship of pulmonary function with pectoralis muscle strength.
연구 개요
상태
완전한
상세 설명
This study consisted of intervention and control groups.
Thirty one patients with ILD were included in the patient's group and 37 healthy volunteers in the control group.
All participants were selected from the geriatric population.
Demographic and cardiopulmonary physiotherapy assessment of all participants were performed.
Lung function test, maximal inspiratory and expiratory pressure and pectoralis muscle strength were measured in participants of both groups.
All measurements were performed once.
연구 유형
관찰
등록 (실제)
68
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Giresun, 칠면조
- Giresun University
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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
65년 (고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
The patient's group was selected from among the patients who applied to Süreyyapaşa Chest Diseases and Thoracic Surgery Training and Research Hospital.
The control group was selected among volunteers invited from the local community.
설명
Inclusion Criteria:
- Diagnosed with ILD by a multidisciplinary team according to the 2011 ATS/ERS guidelines for ILD
- Aged 65-85
Exclusion Criteria:
- Uncontrolled/active cardiovascular, metabolic, systemic or cancerous disease
- Significant orthopedic, neurologic or musculoskeletal comorbidity that limited functional independence
- No being able to cooperate
- Refuse to participate in the current study
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 케이스 컨트롤
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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Patient's group
geriatric patients with interstitial lung disease
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In both groups, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and FEV1 / FVC ratio were measured with portable spirometer according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Maximal inspiratory (MIP) and expiratory pressure (MEP) were evaluated with mouth pressure device as per ATS/ERS guidelines.
Sensation of dyspnea was assessed with Modified medical council research scale.
Pectoralis muscle strength were measured isometrically using with digital hand held dynamometer.
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Control group
healthy volunteers selected from the geriatric population
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In both groups, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and FEV1 / FVC ratio were measured with portable spirometer according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS).
Maximal inspiratory (MIP) and expiratory pressure (MEP) were evaluated with mouth pressure device as per ATS/ERS guidelines.
Sensation of dyspnea was assessed with Modified medical council research scale.
Pectoralis muscle strength were measured isometrically using with digital hand held dynamometer.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Pectoralis muscle strength test
기간: 15 minute
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The pectoralis muscle strength were measured with handheld dynamometer in supine position.
The shoulder joint of participant was positioned at 90º abducted and at 0º internal/external rotation and the elbow joint was flexed at 90º.
The other shoulder joint was fixed by the physiotherapist.
While the participant performed isometrically horizontal adduction movement, the measurement was performed on the distal part of the upper arm and the contraction was sustained for at least 5 seconds by the participant.
The test was performed three times and with 60 seconds rest between tests.
The mean of the best value on both sides was recorded.
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15 minute
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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FEV1
기간: 5 minute
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FEV1 value was measured with portable spirometer according to ATS/ ERS guidelines for pulmonary function test.
Results of the measurements were recorded as percentanges of predicted values.
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5 minute
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FVC
기간: 5 minute
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FVC value was measured with portable spirometer according to ATS/ ERS guidelines for pulmonary function test.
Results of the measurements were recorded as percentanges of predicted values.
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5 minute
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FEV1/FVC
기간: 5 minute
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The ratio of FEV1/FVC was calculated by measuring device according to measured FEV1 and FVC values
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5 minute
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Respiratory muscle strength test
기간: 15 minute
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Maximal mouth pressures were measured to evaluate respiratory muscle strength.
The test was performed with mouth pressure device in sitting position.
Participants breathed through a flanged mouthpiece inside the lips at near residual volume for the MIP value and near total lung capacity for MEP value .
The maximum effort was sustained for at least one second.
The test was repeated at least 3 times until no more than 10% difference was present between highest and previous measurements .
The higest value and percentage value of predicted highest value were recorded
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15 minute
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Dyspnea assessment
기간: 3 minute
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Modified Medical Council Research Dyspnea scale were used to assess sensation of dyspnea
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3 minute
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Habibe DURDU, MSc, Giresun 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
- Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
- Hirano M, Katoh M, Kawaguchi S, Uemura T. Intrarater reliabilities of shoulder joint horizontal adductor muscle strength measurements using a handheld dynamometer for geriatric and stroke patients. J Phys Ther Sci. 2016 Jan;28(1):51-5. doi: 10.1589/jpts.28.51. Epub 2016 Jan 30.
- Panagiotou M, Polychronopoulos V, Strange C. Respiratory and lower limb muscle function in interstitial lung disease. Chron Respir Dis. 2016 May;13(2):162-72. doi: 10.1177/1479972315626014. Epub 2016 Jan 14.
- Hanada M, Sakamoto N, Ishimatsu Y, Kakugawa T, Obase Y, Kozu R, Senjyu H, Izumikawa K, Mukae H, Kohno S. Effect of long-term treatment with corticosteroids on skeletal muscle strength, functional exercise capacity and health status in patients with interstitial lung disease. Respirology. 2016 Aug;21(6):1088-93. doi: 10.1111/resp.12807. Epub 2016 May 13.
- Durdu H, Yurdalan SU, Ozmen I. Clinical significance of pectoralis muscle strength in elderly patients with idiopathic pulmonary fibrosis. Sarcoidosis Vasc Diffuse Lung Dis. 2022;39(1):e2022009. doi: 10.36141/svdld.v39i1.12094. Epub 2022 Mar 31.
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)
2017년 1월 23일
기본 완료 (실제)
2017년 6월 23일
연구 완료 (실제)
2017년 6월 23일
연구 등록 날짜
최초 제출
2021년 3월 13일
QC 기준을 충족하는 최초 제출
2021년 3월 16일
처음 게시됨 (실제)
2021년 3월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 3월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 3월 16일
마지막으로 확인됨
2021년 3월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Pectoralismajor
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니
IPD 계획 설명
The data sets collected and analyzed during this study could be provided from corresponding author upon reasonable request
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. .