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Status unknownNCT01650857Updated Aug 20, 2015

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

An observational study in Pulmonary Hypertension: Efficacy of Rehabilitation, sponsored by Hannover Medical School. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-08-20.

Sponsored by Hannover Medical School · Observational

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Pulmonary Hypertension: Efficacy of Rehabilitation

Keywords

  • Pulmonary hypertension
  • Rehabilitation
  • Exercise capacity
  • Body composition
  • Health related Quality of Life
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In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 100 is below the median of 116 across 386 observational studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Patients with pulmonary hypertension in World Heart Organization functional classification classes (FC) II and III

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Functional class I and IV
  • Right heart decompensation
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
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What researchers measure

Primary outcomes

  1. Exercise capacity

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

    Time frame: 3 weeks

Secondary outcomes

  1. Body composition

    Body composition (bioimpedance analysis)

    Time frame: 3 weeks

Other outcomes

  1. Health related Quality of Life

    Health related Quality of Life (Short form 36 questionnaire)

    Time frame: 3 weeks

  2. Right ventricular function

    Right ventricular function (echocardiography: estimated right ventricular systolic pressure, Tricuspid annular plane systolic excursion, left ventricular eccentricity index)

    Time frame: 3 weeks

  3. Activities of daily living

    Activities of daily living (Barthel's Index)

    Time frame: 3 weeks

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Study locations

1 of 1 sites recruiting
  • Klinik Bad Fallingbostel
    Bad Fallingbostel, Lower Saxony 29683, Germany
    Recruiting
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References and documents

Publications

  • Rosenkranz S, Ghofrani HA, Grunig 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. No abstract available. PubMed 22221968 ↗
  • 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); Galie 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. No abstract available. PubMed 19749199 ↗
  • 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, Grunig 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. doi: 10.1161/CIRCULATIONAHA.106.618397. Epub 2006 Sep 18. PubMed 16982941 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 20, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01650857
Lead sponsor
Hannover Medical School
Collaborators
Klinik Bad Fallingbostel
Responsible party
Martin G Dierich, MD (MD, Hannover Medical School) — Principal investigator
First posted
Jul 26, 2012
Start date
Apr 2010
Primary completion
Aug 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Aug 20, 2015

Study contacts

Martin G Dierich, MD
Contact
dierich.martin@mh-hannover.de
+49 532 3530
Thomas Fuehner, MD
Contact
fuehner.thomas@mh-hannover.de
+ 49 532 3530
Martin G Dierich, MD
principal investigator · Department of Respiratory Diseases, Hannover Medical School

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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