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临床试验/NCT01650857
NCT01650857Unknown不适用

Pulmonary Hypertension: Efficacy of a 3 Week Inpatient Pulmonary Rehabilitation on Physical Condition, Body Composition and Health Related Quality of Life - an Observational Study

Hannover Medical School1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Exercise capacity

研究概览

简要总结

Pulmonary hypertension (PH) leads to impaired physical condition (PC), body composition (BC) and health-related quality of life (HRQOL). We hypothesized that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL.

详细描述

Pulmonary hypertension (PH) impairs physical condition (PC), body composition (BC) and health-related quality of life (HRQOL).

Specific pharmacological treatment and - in selected patients, refractory to agents - lung or combined heart and lung transplantation can improve physical functioning and long term survival. Initial trials with limited numbers of patients were encouraging. Investigation of larger cohorts is essential to assess the efficacy of rehabilitation programmes in PH.

We hypothesize that a 3 week inpatient pulmonary rehabilitation (PR) improves PC, BC and HRQOL in patients with PH in functional classes (FC) II and III. Critical ill patients with a functional class IV are excluded. All patients with PH undergo a 3-week inpatient rehabilitation program (interval bicycle and strength training, physiotherapy, psychological support, education). Exercise testing (peak work load (PWL) 6-min-walk distance), body composition (bioimpedance analysis BIA: lean body mass (LBM), body cell mass (BCM), BCM/LBM ratio, phase angle (PA)) and HRQOL (SF 36 questionnaire) are assessed at baseline and completion of PR.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of pulmonary hypertension
  • Functional class II-III

排除标准

  • Functional class I and IV
  • Right heart decompensation

结局指标

主要结局

Exercise capacity

时间窗: 3 weeks

Exercise capacity (peak work load and 6-minute walk distance at completion of an 3-week inpatient pulmonary rehabilitation)

次要结局

  • Body composition(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin G Dierich, MD

MD

Hannover Medical School

研究点 (1)

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