Physiotherapy in Hypoxic AECOPD Patients
2020년 3월 2일 업데이트: Marie Carmen Valenza, Universidad de Granada
Feasibility and Efficacy of Physiotherapy in Hypoxic AECOPD Patients
Hypoxia is considered a key player in many of the comorbidities that characterize COPD, such as pulmonary hypertension, skeletal muscle dysfunction, and systemic inflammation.
These comorbidities are worsened during an exacerbation due to prolonged bed rest and treatment with steroids, showing a reduction in the quality of life, exercise tolerance, and a greater risk of death in these patients.
Therefore, a better understanding of the safety and effectiveness of exercise training for AECOPD patients with resting hypoxemia is needed.
연구 개요
상태
알려지지 않은
정황
연구 유형
중재적
등록 (예상)
36
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Granada
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Granada., Granada, 스페인, 18071
- 모병
- Faculty of Health Sciences. University of Granada.
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연락하다:
- Marie Carmen Valenza, PT
- 전화번호: 958 248035
- 이메일: cvalenza@ugr.es
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수석 연구원:
- Marie Carmen Valenza, PT, PhD
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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
40년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Patients of both sexes
- A diagnosis of COPD made according to the criteria of the American Thoracic Society (ATS)
- With hypoxemia at rest defined as mean arterial oxygen saturation below 90%
- Agreed to participate
Exclusion Criteria:
- Unstable cardiovascular disease
- Orthopedic diseases in the upper and lower limbs
- Being in ICU or use of mechanical ventilation
- Motor sequelae from a neurological or cognitive impairment that interfere with the evaluation and the treatment
- Contraindications of electrotherapy
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Global Exercise Group
all patients received the Control Group treatment added to global exercise treatment.
The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises.
The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises.
The number of repetitions was adapted to the subject's response taken into account the perceived dyspnea and fatigue during the exercise performance.
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The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises.
The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises
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실험적: Functional Electrostimulation Group
all patients received the Control Group treatment plus neuromuscular stimulation therapy (SEFAR Rehab X2, DJO France S.A.S., France) on quadriceps accompanied by lower limb exercises. The intervention was performed following the protocol described by Valenza et al (2017). Valenza MC, Torres-Sánchez I, López-López L, Cabrera-Martos I, Ortiz-Rubio A, Valenza-Demet G. Effects of home-based neuromuscular electrical stimulation in severe chronic obstructive pulmonary disease patients: a randomized controlled clinical trial. Eur J Phys Rehabil Med. 2018 Jun;54(3):323-332. doi: 10.23736/S1973-9087.17.04745-1. Epub 2017 Nov 16. PubMed PMID: 29144103. |
The program included a neuromuscular stimulation therapy on quadriceps accompanied by lower limb exercises. The intervention was performed following the protocol described by Valenza et al (2017). Valenza MC, Torres-Sánchez I, López-López L, Cabrera-Martos I, Ortiz-Rubio A, Valenza-Demet G. Effects of home-based neuromuscular electrical stimulation in severe chronic obstructive pulmonary disease patients: a randomized controlled clinical trial. Eur J Phys Rehabil Med. 2018 Jun;54(3):323-332. doi: 10.23736/S1973-9087.17.04745-1. Epub 2017 Nov 16. PubMed PMID: 29144103. |
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활성 비교기: Standard treatment
Patients received standard medical and pharmacological care that consisted in systemic steroids, inhaled bronchodilators, oxygen, and a regimen of oral prednisone or its equivalent in doses of 40 to 60 mg per day for the duration of therapy as well as anti-biotic therapy.
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Patients received standard medical and pharmacological care that consisted in systemic steroids, inhaled bronchodilators, oxygen, and a regimen of oral prednisone or its equivalent in doses of 40 to 60 mg per day for the duration of therapy as well as anti-biotic therapy
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Lower limb strength
기간: Baseline
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Quadriceps strength was assessed with a portable hand-held dynamometer (Lafayette Manual Muscle Testing System, model 01163, Lafayette, IN, USA).
The test was performed with the patient seated with his/her knees and hips flexed at 90°.
Resistance was applied to the anterior tibia during 5 seconds of maximal muscle contraction.
The test was repeated alternatively 3 times on the leg, allowing participants to rest between measurements.
The highest value in Newton was selected for the analysis.
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Baseline
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Lower limb strength
기간: Up to 9 days
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Quadriceps strength was assessed with a portable hand-held dynamometer (Lafayette Manual Muscle Testing System, model 01163, Lafayette, IN, USA).
The test was performed with the patient seated with his/her knees and hips flexed at 90°.
Resistance was applied to the anterior tibia during 5 seconds of maximal muscle contraction.
The test was repeated alternatively 3 times on the leg, allowing participants to rest between measurements.
The highest value in Newton was selected for the analysis.
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Up to 9 days
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Balance
기간: Baseline
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Balance was evaluated by the one-leg standing balance test (OLS), that measured the time that the patient balances on one leg as long as possible.
The patient choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg.
Higher values mean better balance.
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Baseline
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Balance
기간: Up to 9 days
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Balance was evaluated by the one-leg standing balance test (OLS), that measured the time that the patient balances on one leg as long as possible.
The patient choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg.
Higher values mean better balance.
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Up to 9 days
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Dyspnea
기간: Baseline
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Dyspnea was assessed at rest using the modified Borg scale.
Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)
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Baseline
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Dyspnea
기간: Up to 9 days
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Dyspnea was assessed at rest using the modified Borg scale.
Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)
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Up to 9 days
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Fatigue
기간: Baseline
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Fatigue was evaluated using the Piper Fatigue Scale (PFS) that consists of 22 numerical items which assess multidimensional aspects of fatigue.
The scale measures four dimensions of subjective fatigue: "behavioral/severity", relating to the severity, distress, and degree of disruption in activity of daily living; "affective meaning", relating to the emotional meaning attributed to fatigue; "sensory", relating to the physical symptoms of fatigue; and "cognitive/mood", relating to mental and mood states
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Baseline
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Fatigue
기간: Up to 9 days
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Fatigue was evaluated using the Piper Fatigue Scale (PFS) that consists of 22 numerical items which assess multidimensional aspects of fatigue.
The scale measures four dimensions of subjective fatigue: "behavioral/severity", relating to the severity, distress, and degree of disruption in activity of daily living; "affective meaning", relating to the emotional meaning attributed to fatigue; "sensory", relating to the physical symptoms of fatigue; and "cognitive/mood", relating to mental and mood states
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Up to 9 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
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)
2019년 12월 1일
기본 완료 (실제)
2020년 1월 1일
연구 완료 (예상)
2020년 4월 1일
연구 등록 날짜
최초 제출
2020년 2월 17일
QC 기준을 충족하는 최초 제출
2020년 3월 2일
처음 게시됨 (실제)
2020년 3월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 3월 4일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 3월 2일
마지막으로 확인됨
2020년 3월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- DF0089UG
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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