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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01650857

Enrollment

100

Registered

2012-07-26

Start date

2010-04-30

Completion date

2018-12-31

Last updated

2015-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension: Efficacy of Rehabilitation

Keywords

Pulmonary hypertension, Rehabilitation, Exercise capacity, Body composition, Health related Quality of Life

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

* Functional class I and IV * Right heart decompensation

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Body composition	3 weeks	Body composition (bioimpedance analysis)

Other

Measure	Time frame	Description
Health related Quality of Life	3 weeks	Health related Quality of Life (Short form 36 questionnaire)
Right ventricular function	3 weeks	Right ventricular function (echocardiography: estimated right ventricular systolic pressure, Tricuspid annular plane systolic excursion, left ventricular eccentricity index)
Activities of daily living	3 weeks	Activities of daily living (Barthel's Index)

Countries

Germany

Contacts

Primary ContactMartin G Dierich, MD

dierich.martin@mh-hannover.de+49 532 3530

Backup ContactThomas Fuehner, MD

fuehner.thomas@mh-hannover.de+ 49 532 3530

Outcome results