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

Pulmonary Hypertension: Efficacy of Rehabilitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01650857
• Other study ID #: HannoverMS PH-Reha001
• Status: Recruiting
• Phase: N/A
• First received: July 21, 2012
• Last updated: August 19, 2015
• Start date: April 2010
• Est. completion date: December 2018

Study information

• Verified date: August 2015
• Source: Hannover Medical School
• Contact: Martin G Dierich, MD
• Phone: +49 532 3530
• Email: dierich.martin[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of pulmonary hypertension

• Functional class II-III

Exclusion Criteria:

• Functional class I and IV

• Right heart decompensation

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension: Efficacy of Rehabilitation

Locations

Country	Name	City	State
Germany	Klinik Bad Fallingbostel	Bad Fallingbostel	Lower Saxony

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Klinik Bad Fallingbostel

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Mereles D, Ehlken N, Kreuscher S, Ghofrani S, Hoeper MM, Halank M, Meyer FJ, Karger G, Buss J, Juenger J, Holzapfel N, Opitz C, Winkler J, Herth FF, Wilkens H, Katus HA, Olschewski H, Grünig E. Exercise and respiratory training improve exercise capacity and quality of life in patients with severe chronic pulmonary hypertension. Circulation. 2006 Oct 3;114(14):1482-9. Epub 2006 Sep 18. — View Citation

Rosenkranz S, Ghofrani HA, Grünig E, Hoeper MM. Cologne Consensus Conference on pulmonary hypertension. Int J Cardiol. 2011 Dec;154 Suppl 1:S1-2. doi: 10.1016/S0167-5273(11)70487-9. — View Citation

Task Force for Diagnosis and Treatment of Pulmonary Hypertension of European Society of Cardiology (ESC); European Respiratory Society (ERS); International Society of Heart and Lung Transplantation (ISHLT), Galiè N, Hoeper MM, Humbert M, Torbicki A, Vachiery JL, Barbera JA, Beghetti M, Corris P, Gaine S, Gibbs JS, Gomez-Sanchez MA, Jondeau G, Klepetko W, Opitz C, Peacock A, Rubin L, Zellweger M, Simonneau G. Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2009 Dec;34(6):1219-63. doi: 10.1183/09031936.00139009. Epub 2009 Sep 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Health related Quality of Life	Health related Quality of Life (Short form 36 questionnaire)	3 weeks	No
Other	Right ventricular function	Right ventricular function (echocardiography: estimated right ventricular systolic pressure, Tricuspid annular plane systolic excursion, left ventricular eccentricity index)	3 weeks	No
Other	Activities of daily living	Activities of daily living (Barthel`s Index)	3 weeks	No
Primary	Exercise capacity	Exercise capacity (peak work load and 6-minute walk distance at completion of an 3-week inpatient pulmonary rehabilitation)	3 weeks	No
Secondary	Body composition	Body composition (bioimpedance analysis)	3 weeks	No