Pulmonary HypertensionNCT00491309
Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
A study testing exercise training in people with Pulmonary Hypertension and Connective Tissue Disease, run by Heidelberg University at 1 site in Germany.
Trial summary
In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Hypertension, Connective Tissue Disease
- What is being tested?
- exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2011to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Men and women 18 - 80 years
- Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease)
- Symptomatic PAH (WHO- functional class II-IV) invasively diagnosed by right heart catheterisation
- Mean pulmonary artery pressure (mPAP) > 25 mmHg
- Pulmonary capillary wedge pressure (PCWP) > 15 mmHg
- Pulmonary vascular resistance (PVR) at baseline >320 dyn.sec/cm5 patients under optimized medical treatment since at least 2 ½ months
Who cannot join
- Other forms of PAH.
- Pregnancy or lactation
- Change in medication during the last 2 ½ months
- Patients with signs of right heart decompensation
- Severe impairment of walking
- Unclear diagnosis
Show all 9Show fewer
- No invasive diagnosis of PH
- Acute illness, infection, fever
- Severe lung disease with FEV1 <50% and TLC< 70% below reference
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Thoraxclinic at the University Hospital Heidelberg
Heidelberg, Baden-Wurttemberg, 69126
Ekkehard Gruenig, MD
About this study
In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.
- Conditions
- Pulmonary Hypertension, Connective Tissue Disease
- Being tested
- exercise training
- Medical subject headings
- Hypertension, Pulmonary, Connective Tissue Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)
| Study group | Role | What they receive |
|---|---|---|
| exercise training group | Active comparator | exercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training) Receives: Behavioral: exercise training |
| Control group without exercise training | No intervention | continuation of sedentary lifestyle without advice for specific exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the 6-minute walking distance
Measured: after 3 weeks and after 15 weeks compared to baseline.
Quality of life (SF-36)
Measured: baseline and 15 weeks
Secondary outcomes (6)
change in inflammatory parameters (BKS, CRP, Leucocytes), change in inflammatory cytokines (TNF-α), change in parameters of the vascular endothelium (Endothelin, PDGF, VEGF), and endothelial progenitor cells
Measured: baseline and 15 weeks
Physical capacity in the cardiopulmonary exercise testing (Watt)
Measured: baseline, 3 weeks, 15 weeks
change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.
Measured: baseline, 3 weeks, 15 weeks
hemodynamic parameters: dimension and pump function of the right and the left ventricle.
Measured: baseline, 15 weeks
change in systolic pulmonary arterial pressure at rest and during exercise
echocardiography
Measured: baseline, 3 weeks, 15 weeks
change of NTproBNP-value
Measured: baseline, 3 weeks, 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2007 (estimated)
- Study startJul 2011
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med. Ekkehard Gruenig, Heidelberg University
- Investigators
- Ekkehard Gruenig, MD, Principal investigator, Thoraxclinic at the University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00491309
- Sponsor's protocol ID
- Reha PH Rheumatic
- Status last verified
- Jul 2022
- First submitted
- 25 Jun 2007
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Grunig E, Maier F, Ehlken N, Fischer C, Lichtblau M, Blank N, Fiehn C, Stockl F, Prange F, Staehler G, Reichenberger F, Tiede H, Halank M, Seyfarth HJ, Wagner S, Nagel C. Exercise training in pulmonary arterial hypertension associated with connective tissue diseases. Arthritis Res Ther. 2012 Jun 18;14(3):R148. doi: 10.1186/ar3883.
PubMed 22709477
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT00491309
- Acronym / sponsor ID
- Reha PH Rheumatic
- Conditions
- Pulmonary Hypertension, Connective Tissue Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 26 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In Patients with rheumatic disease exercise training is a well established element of therapy. In contrast patients with severe pulmonary hypertension are advised to avoid physical exertion and must not perform exercise training. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise training group | Active comparator | Behavioral: exercise trainingexercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training) |
| Control group without exercise training | No intervention | –continuation of sedentary lifestyle without advice for specific exercise training |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Informed consent
- Men and women 18 - 80 years
- Diagnosed rheumatic disease: rheumatoid arthritis, Collagenosis (Systemic Lupus Erythematodes, Systemic Sclerosis, Sjögren-Syndrome, Sharp-Syndrome, Crest-Syndrome, Mixed connective tissue disease)
- Symptomatic PAH (WHO- functional class II-IV) invasively diagnosed by right heart catheterisation
Key exclusion criteria (9 listed)
- Other forms of PAH.
- Pregnancy or lactation
- Change in medication during the last 2 ½ months
- Patients with signs of right heart decompensation
- Severe impairment of walking
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise trainingexercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training) | Behavioural | exercise training group |
Primary outcome
Change in the 6-minute walking distance
Time frame: after 3 weeks and after 15 weeks compared to baseline.
Quality of life (SF-36)
Time frame: baseline and 15 weeks
6 secondary outcomes
change in inflammatory parameters (BKS, CRP, Leucocytes), change in inflammatory cytokines (TNF-α), change in parameters of the vascular endothelium (Endothelin, PDGF, VEGF), and endothelial progenitor cells
Time frame: baseline and 15 weeks
Physical capacity in the cardiopulmonary exercise testing (Watt)
Time frame: baseline, 3 weeks, 15 weeks
change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.
Time frame: baseline, 3 weeks, 15 weeks
hemodynamic parameters: dimension and pump function of the right and the left ventricle.
Time frame: baseline, 15 weeks
change in systolic pulmonary arterial pressure at rest and during exercise
Time frame: baseline, 3 weeks, 15 weeks
change of NTproBNP-value
Time frame: baseline, 3 weeks, 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2022.
- Derived from this study: PubMed 22709477Grunig E, Maier F, Ehlken N, Fischer C, Lichtblau M, Blank N, Fiehn C, Stockl F, Prange F, Staehler G, Reichenberger F, Tiede H, Halank M, Seyfarth HJ, Wagner S, Nagel C. Exercise training in pulmonary arterial hypertension associated with connective tissue diseases. Arthritis Res Ther. 2012 Jun 18;14(3):R148. doi: 10.1186/ar3883.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekkehard Gruenig, MD principal investigator
Thoraxclinic at the University Hospital Heidelberg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training in people with Pulmonary Hypertension and Connective Tissue Disease, run by Heidelberg University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ekkehard Gruenig, MD (+49 6221 396 80 53, ekkehard.gruenig@thoraxklinik-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the 6-minute walking distance (time frame: after 3 weeks and after 15 weeks compared to baseline.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00491309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2022.