Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients with Interstitial Lung Disease
Exercise Therapy for Advanced Lung Disease Trials: Response and Adaptation to Aerobic Exercise in Patients with Interstitial Lung Disease
批准号:
10007389
负责人:
Leighton Chan
金额:
$0.0万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
AerobicAerobic ExerciseBehavioralCell RespirationChronic Obstructive Airway DiseaseConsentDataDropoutDropsEmergency SituationEnergy MetabolismEnrollmentEtiologyExerciseExercise TherapyExercise stress testFailureFamilyFatigueGuidelinesHealth StatusHealth SurveysHuman ActivitiesInterstitial Lung DiseasesInterventionLifeLung diseasesMeasuresMedicalMetabolicModalityMoodsMuscleOutcomeOutcome MeasurePatient CarePatientsPhysical activityProtocols documentationPublic HealthPulmonary Gas ExchangePulmonary HypertensionQuestionnairesRandomizedRegimenRehabilitation therapyResearchSafetySerious Adverse EventSeveritiesSupervisionSymptomsTest ResultTestingTimeTrainingTraining ProgramsUncontrolled StudyWalkingWithdrawalWorkbaseexercise rehabilitationexercise traininghealth related quality of lifeimprovedindexingpatient safetyprimary outcomepsychosocialpulmonary rehabilitationrespiratoryresponsesecondary outcomestandard of caretreadmill
中文摘要
AET通常是安全、廉价的,几乎每个人都可以很容易地获得和接触到AET。它不需要得到监管机构的批准,因此在其安全性和有效性得到确认后,几乎立即可以作为一种医学处方和监督干预措施。6分钟步行距离与ILD患者和特定亚组患者的HRQL改善相关。有效地使用AET作为康复干预措施可能会对这一晚期肺部疾病亚组的个人和公共健康结果产生高度影响。
筛选的受试者总数=161
注册科目总数=28
本年度入学总人数=4人
今年退学的科目总数=0
同意人数(包括屏幕故障和退学/退学):
在协议的有效期内=42
自上次CR=6以来(4名受试者被认为已完成随机分组;2名受试者因筛查失败而未被入选-见下文)
同意这项研究但因筛查失败而未入选的两名受试者:
1例因肺动脉高压筛查失败
一名患者因家庭紧急情况退出治疗
英文摘要
AET is generally safe, inexpensive, and can easily be made available and accessible to almost everyone. It requires no approval by regulatory agencies and is thus available as a medically prescribed and supervised intervention almost immediately following confirmation of its safety and efficacy. Six-minute walk distance is associated with improved HRQoL in patients with ILD and in specific subsets. Effective use of AET as a rehabilitative intervention could have a high degree of impact on personal and public health outcomes in this advanced lung disease subset.
Total Number of Subjects Screened=161
Total Number of Subjects Enrolled = 28
Total Number of Subjects Enrolled in the current year = 4
Total Number of Subjects Enrolled that dropped this year =0
Number consented (including screen failures and withdrawals/dropouts):
over the life of the protocol = 42
since last CR = 6 (4 subjects are considered "enrolled" as having completed randomization; 2 subjects were not "enrolled" due to screen failure - see below)
The 2 subjects who were consented to the study but were not enrolled due to screen failure:
One patient was screen failure due to pulmonary hypertension
One patient withdrew due to family emergency
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