Back to results

Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

Primary Purpose

Pulmonary Hypertension, Connective Tissue Disease

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

exercise training

About this trial

This is an interventional treatment trial for Pulmonary Hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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
No invasive diagnosis of PH
Acute illness, infection, fever
Severe lung disease with FEV1 <50% and TLC< 70% below reference

Sites / Locations

Thoraxclinic at the University Hospital HeidelbergRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

exercise training group

Control group without exercise training

Arm Description

exercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training)

continuation of sedentary lifestyle without advice for specific exercise training

Outcomes

Primary Outcome Measures

Change in the 6-minute walking distance

Quality of life (SF-36)

Secondary Outcome Measures

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

Physical capacity in the cardiopulmonary exercise testing (Watt)

change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.

hemodynamic parameters: dimension and pump function of the right and the left ventricle.

change in systolic pulmonary arterial pressure at rest and during exercise

echocardiography

change of NTproBNP-value

Full Information

NCT ID

NCT00491309

First Posted

June 25, 2007

Last Updated

July 12, 2022

Sponsor

Heidelberg University

1. Study Identification

Unique Protocol Identification Number

NCT00491309

Brief Title

Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

Official Title

Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Recruiting

Study Start Date

July 2011 (undefined)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Heidelberg University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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. This study aims to evaluate the effectivity and safety of a low-dose training program in patients with pulmonary hypertension and rheumatic disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Hypertension, Connective Tissue Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

exercise training group

Arm Type

Active Comparator

Arm Description

exercise and respiratory therapy with specific program for pulmonary hypertension (respiratory therapy, dumbbell training, ergometer training, mental training)

Arm Title

Control group without exercise training

Arm Type

No Intervention

Arm Description

continuation of sedentary lifestyle without advice for specific exercise training

Intervention Type

Behavioral

Intervention Name(s)

exercise training

Intervention Description

exercise training with specific program (respiratory therapy, dumbbell training, ergometer training, mental training)

Primary Outcome Measure Information:

Title

Change in the 6-minute walking distance

Time Frame

after 3 weeks and after 15 weeks compared to baseline.

Title

Quality of life (SF-36)

Time Frame

baseline and 15 weeks

Secondary Outcome Measure Information:

Title

Time Frame

baseline and 15 weeks

Title

Physical capacity in the cardiopulmonary exercise testing (Watt)

Time Frame

baseline, 3 weeks, 15 weeks

Title

change of peak oxygen consumption and other parameters of cardiopulmonary exercise testing.

Time Frame

baseline, 3 weeks, 15 weeks

Title

hemodynamic parameters: dimension and pump function of the right and the left ventricle.

Time Frame

baseline, 15 weeks

Title

change in systolic pulmonary arterial pressure at rest and during exercise

Description

echocardiography

Time Frame

baseline, 3 weeks, 15 weeks

Title

change of NTproBNP-value

Time Frame

baseline, 3 weeks, 15 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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 No invasive diagnosis of PH Acute illness, infection, fever Severe lung disease with FEV1 <50% and TLC< 70% below reference

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ekkehard Gruenig, MD

Phone

+49 6221 396 80 53

ekkehard.gruenig@thoraxklinik-heidelberg.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ekkehard Gruenig, MD

Organizational Affiliation

Thoraxclinic at the University Hospital Heidelberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thoraxclinic at the University Hospital Heidelberg

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69126

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ekkehard Gruenig, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

22709477

Citation

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.

Results Reference

derived

Learn more about this trial

Exercise and Respiratory Therapy in Patients With Rheumatoid Arthritis / Collagenosis and Pulmonary Hypertension

We'll reach out to this number within 24 hrs